{"protocolSection":{"identificationModule":{"nctId":"NCT02358343","orgStudyIdInfo":{"id":"48647"},"organization":{"fullName":"University of Washington","class":"OTHER"},"briefTitle":"A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}","officialTitle":"ASCEND: A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression","acronym":"ASCEND"},"statusModule":{"statusVerifiedDate":"2019-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-03-23","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2017-11-15","type":"ACTUAL"},"completionDateStruct":{"date":"2017-12-15","type":"ACTUAL"},"studyFirstSubmitDate":"2015-01-13","studyFirstSubmitQcDate":"2015-02-05","studyFirstPostDateStruct":{"date":"2015-02-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-05-31","resultsFirstSubmitQcDate":"2019-07-03","resultsFirstPostDateStruct":{"date":"2019-07-23","type":"ACTUAL"},"lastUpdateSubmitDate":"2019-07-03","lastUpdatePostDateStruct":{"date":"2019-07-23","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Rajnish Mehrotra","investigatorTitle":"Professor of Medicine, Division of Nephrology","investigatorAffiliation":"University of Washington"},"leadSponsor":{"name":"University of Washington","class":"OTHER"},"collaborators":[{"name":"University of Texas","class":"OTHER"},{"name":"University of New Mexico","class":"OTHER"},{"name":"Patient-Centered Outcomes Research Institute","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"Patients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy.\n\nTo fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined.\n\nThe two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.","detailedDescription":"BACKGROUND Patients with end-stage renal disease undergoing maintenance hemodialysis (HD) have to adjust to complex treatment regimens, and experience frequent care transitions. This is compounded by a four-fold higher prevalence of comorbid depression than in the general population, which is strongly associated with poor patient-centered outcomes. Yet, depression is often not diagnosed when present, not treated when identified, and many HD patients are reluctant to accept treatment. This is likely a result of lack of high-quality evidence for the efficacy of different treatment options for comorbid depression in HD patients. OBJECTIVES Conduct an open-label, randomized controlled clinical trial among HD patients with comorbid depression to (1) compare the efficacy of an engagement interview with usual care in increasing acceptability of treatment (n=200); and (2) compare the efficacy of 12 weeks of cognitive behavioral therapy (CBT) or anti-depressant drug therapy (sertraline) for reducing the severity of depressive symptoms, and other meaningful outcomes (n=120). METHODS HD patients in up to 50 dialysis facilities in three different regions (Albuquerque, NM; Dallas, TX; Seattle, WA) will be pre-screened for the presence of clinically significant depressive symptoms. Patients with a confirmed diagnosis of major depression or dysthymia will be randomly assigned to an engagement interview or usual care to determine efficacy in increasing acceptability of treatment (n=200). Individuals who agree to treatment will be randomly assigned to individual CBT or drug therapy. CBT will be administered in a dialysis facility by a trained therapist. Sertraline will be titrated to the maximum tolerated dose using Measurement Based Care, a model of shared-decision-making. Patient-reported outcomes will be measured by a single assessor for all three sites, blinded to the treatment assignment. The primary efficacy measure will be a change in severity of depressive symptoms; secondary outcome measures will assess other important patient-reported outcomes such as somatic symptom burden, functioning, and adherence with dialysis treatment, diet, and medications. The longitudinal evolution of symptoms in patients who refuse to accept any treatment either within or outside the clinical trial will also be studied (n=40). PATIENT OUTCOMES (PROJECTED) This study will provide answers to three questions faced by HD patients with clinically significant depressive symptoms: (1) \"Given my preferences, what should I expect will happen to me?\"; (2) \"What are my options, and what are the potential benefits and harms of these options?\"; and (3) \"What can I do to improve the outcomes that are most important to me?\" Oversight of study will be provided by separate Patient Council and Stakeholder Council to align with PCORI's mission of generating high-integrity, evidence-based information from research guided by patients, caregivers, and broader health care community."},"conditionsModule":{"conditions":["Depression","End Stage Renal Disease"],"keywords":["Comorbid Depression","Major Depressive Disorder","Dysthymia","Cognitive Behavioral therapy (CBT)","Sertraline","Engagement Interview","End Stage Renal Disease (ESRD)","Hemodialysis"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":184,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Engagement Interview","type":"ACTIVE_COMPARATOR","description":"Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.","interventionNames":["Behavioral: Engagement Interview"]},{"label":"Control Visit","type":"NO_INTERVENTION","description":"Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial."},{"label":"Cognitive Behavioral Therapy","type":"ACTIVE_COMPARATOR","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT will be administered while the patient is undergoing HD; however, alternative arrangements will be made upon individual patient's preferences.","interventionNames":["Behavioral: Cognitive Behavioral Therapy"]},{"label":"Antidepressant Drug Therapy","type":"ACTIVE_COMPARATOR","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.","interventionNames":["Drug: Antidepressant Drug Therapy"]},{"label":"Observational Cohort","type":"NO_INTERVENTION","description":"Subjects who (1) are not willing to participate in the clinical trial and (2) do not find any treatment acceptable outside the clinical trial will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C."}],"interventions":[{"type":"BEHAVIORAL","name":"Engagement Interview","description":"An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.","armGroupLabels":["Engagement Interview"]},{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. During the course of intervention, study subjects will undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).","armGroupLabels":["Cognitive Behavioral Therapy"],"otherNames":["CBT"]},{"type":"DRUG","name":"Antidepressant Drug Therapy","description":"The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.","armGroupLabels":["Antidepressant Drug Therapy"],"otherNames":["Sertraline, \"Zoloft\""]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Initiated Depression Treatment","description":"The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition.\n\nThis will be defined as one of the following:\n\n* Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia.\n* Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia.","timeFrame":"within four weeks of engagement interview or control visit"},{"measure":"QIDS-C Score","description":"The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups.","timeFrame":"Week 12 of treatment"}],"secondaryOutcomes":[{"measure":"Number of Participants Who Accepted Depression Treatment","description":"The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment.\n\nThis will be measured by the patient's intent and will be defined as one of the following:\n\n* Signing the informed consent to be randomly assigned to individual CBT or drug therapy\n* Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community.\n* Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia.","timeFrame":"within two weeks of engagement interview or control visit"},{"measure":"BDI-II","description":"Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression","timeFrame":"Week 12"},{"measure":"GAD-7","description":"Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety","timeFrame":"Week 12"},{"measure":"Sheehan Disability Scale","description":"range 0-30, higher scores indicate worse disability","timeFrame":"Week 12"},{"measure":"SF-36 Energy/Vitality","description":"Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality","timeFrame":"Week 12"},{"measure":"Global Quality of Life Scale","description":"range 0-10, higher scores indicate better quality of life","timeFrame":"Week 12"},{"measure":"Satisfaction With Life Scale","description":"range 1-35, higher scores indicate better satisfaction","timeFrame":"Week 12"},{"measure":"Perceived Social Support","description":"Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support","timeFrame":"Week 12"},{"measure":"PSQI","description":"Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality","timeFrame":"Week 12"},{"measure":"Exercise","description":"Single item activity measure, range 1-6, higher indicates less activity","timeFrame":"Week 12"},{"measure":"Percentage of Dialysis Treatment Sessions Skipped and/or Shortened","description":"Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment.","timeFrame":"Over 12 Weeks"},{"measure":"Percent Inter-dialytic Weight Gain","description":"Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study","timeFrame":"Week 12"},{"measure":"Serum Phosphorus Level","description":"Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study.","timeFrame":"Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Age ≥ 21 years;\n2. Undergoing thrice-weekly maintenance HD for ≥ 3 months;\n3. Able to speak either English or Spanish;\n4. BDI-II score ≥ 15; and\n5. Meets diagnostic criteria for either current major depressive episode or dysthymia on the MINI.\n\nExclusion Criteria:\n\n1. Active suicidal intent;\n2. Ongoing psychotherapy or current treatment with certain anti-depressant drugs;\n3. Evidence of cognitive impairment on Mini-Cog;\n4. Present or past psychosis or bipolar disorder I or II on the MINI;\n5. Alcohol or substance abuse diagnosed on the MINI or history of such abuse in the past three months;\n6. Life expectancy \\< 3 months, in the judgment of the site principal investigator;\n7. Anticipated to receive living related donor kidney transplantation within 3 months;\n8. Pregnancy, or lactation, or women of childbearing age not willing to use adequate birth control;\n9. Clinical and/or laboratory evidence of chronic liver disease;\n10. History of significant active bleeding in the past three months, such as hospitalization for gastrointestinal bleeding;\n11. Current use of class I anti-arrhythmic medications (e.g., propafenone, flecainide), pimozide, monoamine oxidase inhibitors, reserpine, guanethidine, cimetidine, tri-cyclic anti-depressants, triptans, tramadol, linezolid, tryptophan, and St. John's wort; and\n12. Known hypersensitivity to sertraline.","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Rajnish Mehrotra, MD","affiliation":"University of Washington","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of New Mexico","city":"Albuquerque","state":"New Mexico","zip":"87131","country":"United States","geoPoint":{"lat":35.08449,"lon":-106.65114}},{"facility":"University of Texas Southwestern","city":"Dallas","state":"Texas","zip":"75390","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Washington","city":"Seattle","state":"Washington","zip":"98195","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"16310620","type":"BACKGROUND","citation":"Davison SN, Jhangri GS. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage. 2005 Nov;30(5):465-73. doi: 10.1016/j.jpainsymman.2005.05.013."},{"pmid":"15975996","type":"BACKGROUND","citation":"Weisbord SD, Fried LF, Arnold RM, Fine MJ, Levenson DJ, Peterson RA, Switzer GE. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol. 2005 Aug;16(8):2487-94. doi: 10.1681/ASN.2005020157. Epub 2005 Jun 23."},{"pmid":"16598203","type":"BACKGROUND","citation":"Hedayati SS, Bosworth HB, Kuchibhatla M, Kimmel PL, Szczech LA. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int. 2006 May;69(9):1662-8. doi: 10.1038/sj.ki.5000308."},{"pmid":"10792629","type":"BACKGROUND","citation":"Kimmel PL, Peterson RA, Weihs KL, Simmens SJ, Alleyne S, Cruz I, Veis JH. Multiple measurements of depression predict mortality in a longitudinal study of chronic hemodialysis outpatients. Kidney Int. 2000 May;57(5):2093-8. doi: 10.1046/j.1523-1755.2000.00059.x."},{"pmid":"18580856","type":"BACKGROUND","citation":"Hedayati SS, Bosworth HB, Briley LP, Sloane RJ, Pieper CF, Kimmel PL, Szczech LA. Death or hospitalization of patients on chronic hemodialysis is associated with a physician-based diagnosis of depression. Kidney Int. 2008 Oct;74(7):930-6. doi: 10.1038/ki.2008.311. Epub 2008 Jun 25."},{"type":"BACKGROUND","citation":"System, U.S.R.D., US Department of Public Health and Human Services, Public Health Service, National Institutes of Health, Bethesda, 2012."},{"pmid":"12169073","type":"BACKGROUND","citation":"Glassman AH, O'Connor CM, Califf RM, Swedberg K, Schwartz P, Bigger JT Jr, Krishnan KR, van Zyl LT, Swenson JR, Finkel MS, Landau C, Shapiro PA, Pepine CJ, Mardekian J, Harrison WM, Barton D, Mclvor M; Sertraline Antidepressant Heart Attack Randomized Trial (SADHEART) Group. Sertraline treatment of major depression in patients with acute MI or unstable angina. JAMA. 2002 Aug 14;288(6):701-9. doi: 10.1001/jama.288.6.701."},{"pmid":"19242502","type":"BACKGROUND","citation":"Cukor D, Rosenthal DS, Jindal RM, Brown CD, Kimmel PL. Depression is an important contributor to low medication adherence in hemodialyzed patients and transplant recipients. Kidney Int. 2009 Jun;75(11):1223-1229. doi: 10.1038/ki.2009.51. Epub 2009 Feb 25."},{"pmid":"11773470","type":"BACKGROUND","citation":"Kutner NG, Zhang R, McClellan WM, Cole SA. Psychosocial predictors of non-compliance in haemodialysis and peritoneal dialysis patients. Nephrol Dial Transplant. 2002 Jan;17(1):93-9. doi: 10.1093/ndt/17.1.93."},{"pmid":"17702730","type":"BACKGROUND","citation":"Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8."},{"pmid":"24115478","type":"BACKGROUND","citation":"Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10."},{"pmid":"19455196","type":"BACKGROUND","citation":"Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20."},{"pmid":"19953347","type":"BACKGROUND","citation":"Atalay H, Solak Y, Biyik M, Biyik Z, Yeksan M, Uguz F, Guney I, Tonbul HZ, Turk S. Sertraline treatment is associated with an improvement in depression and health-related quality of life in chronic peritoneal dialysis patients. Int Urol Nephrol. 2010 Jun;42(2):527-36. doi: 10.1007/s11255-009-9686-y. Epub 2009 Dec 2."},{"pmid":"18684897","type":"BACKGROUND","citation":"Cukor D, Coplan J, Brown C, Peterson RA, Kimmel PL. Course of depression and anxiety diagnosis in patients treated with hemodialysis: a 16-month follow-up. Clin J Am Soc Nephrol. 2008 Nov;3(6):1752-8. doi: 10.2215/CJN.01120308. Epub 2008 Aug 6."},{"pmid":"19493600","type":"BACKGROUND","citation":"Hedayati SS, Minhajuddin AT, Toto RD, Morris DW, Rush AJ. Validation of depression screening scales in patients with CKD. Am J Kidney Dis. 2009 Sep;54(3):433-9. doi: 10.1053/j.ajkd.2009.03.016. Epub 2009 Jun 3."},{"pmid":"16728903","type":"BACKGROUND","citation":"Wisniewski SR, Rush AJ, Balasubramani GK, Trivedi MH, Nierenberg AA; STARD Investigators. Self-rated global measure of the frequency, intensity, and burden of side effects. J Psychiatr Pract. 2006 Mar;12(2):71-9. doi: 10.1097/00131746-200603000-00002."},{"pmid":"12946886","type":"BACKGROUND","citation":"Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8."},{"pmid":"37651553","type":"DERIVED","citation":"Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2."},{"pmid":"30802897","type":"DERIVED","citation":"Mehrotra R, Cukor D, Unruh M, Rue T, Heagerty P, Cohen SD, Dember LM, Diaz-Linhart Y, Dubovsky A, Greene T, Grote N, Kutner N, Trivedi MH, Quinn DK, Ver Halen N, Weisbord SD, Young BA, Kimmel PL, Hedayati SS. Comparative Efficacy of Therapies for Treatment of Depression for Patients Undergoing Maintenance Hemodialysis: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 19;170(6):369-379. doi: 10.7326/M18-2229. Epub 2019 Feb 26."},{"pmid":"26621218","type":"DERIVED","citation":"Hedayati SS, Daniel DM, Cohen S, Comstock B, Cukor D, Diaz-Linhart Y, Dember LM, Dubovsky A, Greene T, Grote N, Heagerty P, Katon W, Kimmel PL, Kutner N, Linke L, Quinn D, Rue T, Trivedi MH, Unruh M, Weisbord S, Young BA, Mehrotra R. Rationale and design of A Trial of Sertraline vs. Cognitive Behavioral Therapy for End-stage Renal Disease Patients with Depression (ASCEND). Contemp Clin Trials. 2016 Mar;47:1-11. doi: 10.1016/j.cct.2015.11.020. Epub 2015 Nov 24."}],"seeAlsoLinks":[{"label":"Kidney Research Institute","url":"http://kri.washington.edu"}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants screened at 3 sites in the United States.","groups":[{"id":"FG000","title":"Engagement Interview","description":"An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home."},{"id":"FG001","title":"Control Visit","description":"A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial."},{"id":"FG002","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT is administered while the patient is undergoing hemodialysis unless alternative arrangements preferred by participant. During the course of intervention, study subjects undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12)."},{"id":"FG003","title":"Antidepressant Drug Therapy","description":"Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This protocol establishes the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks."},{"id":"FG004","title":"Observational Cohort","description":"Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study will be invited to participate in the prospective observational cohort for serial assessment of depressive symptoms.These subjects will only undergo assessment of severity of depressive symptoms at weeks 0, 6, and 12 using QIDS-C."}],"periods":[{"title":"Screening Intervention","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"90 completed engagement interview","numSubjects":"92"},{"groupId":"FG001","comment":"89 completed control visit","numSubjects":"92"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Determined Ineligible","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]},{"title":"Comparative Efficacy Trial / Observation","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Participants enrolled in screening intervention enrolled in comparative efficacy trial","numSubjects":"0"},{"groupId":"FG001","comment":"Participants enrolled in screening intervention enrolled in comparative efficacy trial","numSubjects":"0"},{"groupId":"FG002","comment":"44 completed treatment","numSubjects":"60"},{"groupId":"FG003","comment":"47 completed treatment","numSubjects":"60"},{"groupId":"FG004","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"55"},{"groupId":"FG003","numSubjects":"58"},{"groupId":"FG004","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"}]},{"type":"Administrative Withdrawal","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Participants in the comparitive efficacy/observation period (N=140) are a subset of participants in the screening intervention period (N=184). Total enrolled in the study is 184 (NOT 324).","groups":[{"id":"BG000","title":"Engagement Interview","description":"An Engagement Interview is a one-on-one session with the participant, during which a trained cognitive behavioral therapist explores barriers to treatment, including watching a 40-minute DVD together, in the dialysis facility. The DVD is given to the participant to take home."},{"id":"BG001","title":"Control Visit","description":"A control visit is a follow up discussion with the participant at the dialysis facility by research staff. During this visit, participants are informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial."},{"id":"BG002","title":"Cognitive Behavioral Therapy","description":"Cognitive Behavioral Therapy (CBT) consists of 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"BG003","title":"Antidepressant Drug Therapy","description":"Anti-Depressant Drug Therapy is sertraline, a selective serotonin reuptake inhibitor, and is delivered for 12 weeks. The site investigators prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration is implemented using standardized assessments of depressive symptoms and drug side effects."},{"id":"BG004","title":"Obsevational Cohort","description":"Subjects who (1) are not willing to be randomized to study treatment and (2) do not find treatment acceptable even outside the study."},{"id":"BG005","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"324"}]}],"measures":[{"title":"Age, Continuous","populationDescription":"Screening Intervention Period","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"184"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"52","spread":"14"},{"groupId":"BG001","value":"53","spread":"12"},{"groupId":"BG005","value":"53","spread":"13"}]}]}]},{"title":"Age, Continuous","populationDescription":"Comparative Efficacy Trial / Observation Period","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"140"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"50","spread":"13"},{"groupId":"BG003","value":"53","spread":"12"},{"groupId":"BG004","value":"53","spread":"13"},{"groupId":"BG005","value":"52","spread":"13"}]}]}]},{"title":"Sex: Female, Male","populationDescription":"Screening Intervention Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"184"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"35"},{"groupId":"BG005","value":"77"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"57"},{"groupId":"BG005","value":"107"}]}]}]},{"title":"Sex: Female, Male","populationDescription":"Comparative Efficacy Trial / Observation Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"140"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"59"}]},{"title":"Male","measurements":[{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"35"},{"groupId":"BG004","value":"13"},{"groupId":"BG005","value":"81"}]}]}]},{"title":"Ethnicity (NIH/OMB)","populationDescription":"Screening Intervention Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"184"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"22"},{"groupId":"BG005","value":"49"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"65"},{"groupId":"BG001","value":"69"},{"groupId":"BG005","value":"134"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG005","value":"1"}]}]}]},{"title":"Ethnicity (NIH/OMB)","populationDescription":"Comparative Efficacy Trial / Observation Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"140"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"20"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"39"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG002","value":"46"},{"groupId":"BG003","value":"39"},{"groupId":"BG004","value":"15"},{"groupId":"BG005","value":"100"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","populationDescription":"Screening Intervention Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"184"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG005","value":"15"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG005","value":"7"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG005","value":"6"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"32"},{"groupId":"BG005","value":"53"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"29"},{"groupId":"BG005","value":"77"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG005","value":"5"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"12"},{"groupId":"BG005","value":"21"}]}]}]},{"title":"Race (NIH/OMB)","populationDescription":"Comparative Efficacy Trial / Observation Period","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"140"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"10"}]},{"title":"Asian","measurements":[{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"3"},{"groupId":"BG005","value":"6"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"4"}]},{"title":"Black or African American","measurements":[{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"15"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"40"}]},{"title":"White","measurements":[{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"28"},{"groupId":"BG004","value":"8"},{"groupId":"BG005","value":"60"}]},{"title":"More than one race","measurements":[{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"4"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"16"}]}]}]},{"title":"Dialysis Vintage","description":"Months since most recent initiation of dialysis","populationDescription":"Screening Intervention Period","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"months","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"184"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"32","lowerLimit":"17","upperLimit":"60"},{"groupId":"BG001","value":"28","lowerLimit":"15","upperLimit":"78"},{"groupId":"BG005","value":"31","lowerLimit":"15","upperLimit":"70"}]}]}]},{"title":"Dialysis Vintage","description":"Months since most recent initiation of dialysis","populationDescription":"Comparative Efficacy Trial / Observation Period","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"months","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"60"},{"groupId":"BG003","value":"60"},{"groupId":"BG004","value":"20"},{"groupId":"BG005","value":"140"}]}],"categories":[{"measurements":[{"groupId":"BG002","value":"30","lowerLimit":"16","upperLimit":"69"},{"groupId":"BG003","value":"32","lowerLimit":"18","upperLimit":"61"},{"groupId":"BG004","value":"21","lowerLimit":"11","upperLimit":"63"},{"groupId":"BG005","value":"31","lowerLimit":"15","upperLimit":"70"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Initiated Depression Treatment","description":"The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition.\n\nThis will be defined as one of the following:\n\n* Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia.\n* Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"within four weeks of engagement interview or control visit","groups":[{"id":"OG000","title":"Engagement Interview","description":"Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.\n\nEngagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well."},{"id":"OG001","title":"Control Visit","description":"Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"84"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"54"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.77","pValueComment":"a priori threshold for significance is 0.05.","statisticalMethod":"Likelihood Ratio Test","statisticalComment":"Likelihood ratio test obtained from logistic regression analysis adjusting for site"}]},{"type":"PRIMARY","title":"QIDS-C Score","description":"The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups.","populationDescription":"QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12 of treatment","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2). The CBT will be administered while the patient is undergoing hemodialysis; however, alternative arrangements will be made upon individual patient's preferences.\n\nCognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.\n\nAntidepressant Drug Therapy: The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d,"},{"id":"OG002","title":"Observational Cohort","description":"Participants not accepting treatment but consented to be followed."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"18"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.1","lowerLimit":"6.7","upperLimit":"9.4"},{"groupId":"OG001","value":"5.9","lowerLimit":"4.8","upperLimit":"7.1"},{"groupId":"OG002","value":"7.9","lowerLimit":"6.1","upperLimit":"9.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"All participants randomized to treatment (N=120) were included in the pre-specified longitudinal model of QIDS-C used to estimate comparative treatment effect at 12 weeks (primary outcome). The model adjustment for clinical site and included baseline, 6 week and 12 week QIDS-C scores. Week 0 (baseline) and week 6 measurements are not pre-specified primary or secondary outcomes. The Observational Cohort arm was not included in the analysis.","nonInferiorityType":"SUPERIORITY","pValue":"0.035","pValueComment":"a priori threshold for significance is 0.05.","statisticalMethod":"Wald Test","statisticalComment":"The Wald test is for the week 12 comparative treatment effect from a longitudinal model of QIDS-C adjusting for clinical site.","paramType":"Mean Difference (Final Values)","paramValue":"-1.84","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.54","ciUpperLimit":"-0.13","estimateComment":"The week 12 mean difference estimated from the longitudinal model is the difference between antidepressant drug therapy (drug) and the cognitive behavioral therapy (CBT) at 12 weeks, (drug - CBT)."}]},{"type":"SECONDARY","title":"Number of Participants Who Accepted Depression Treatment","description":"The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment.\n\nThis will be measured by the patient's intent and will be defined as one of the following:\n\n* Signing the informed consent to be randomly assigned to individual CBT or drug therapy\n* Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community.\n* Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia.","populationDescription":"Screening Intervention Period. Two participants who died both consented to treatment within the clinical trial and therefore were counted as non-missing for accepting treatment outcome by definition even though they did not complete the study.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"within two weeks of engagement interview or control visit","groups":[{"id":"OG000","title":"Engagement Interview","description":"Subjects will be randomly assigned to engagement interview or a control visit.Trained CBT therapists at each of the three sites will conduct the engagement interview. The session will be aimed at improving the acceptance of the diagnosis of depression by patients and treatment for the same.\n\nEngagement Interview: An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well."},{"id":"OG001","title":"Control Visit","description":"Subjects will be randomly assigned to engagement interview or a control visit. Individuals assigned to control visit will be scheduled for a follow-up discussion with a member of the research team. During this session, they will be informed of the diagnosis of major depression or dysthymia, the options for treatment available through the clinical trial, and alternatives should they decline participation in the clinical trial."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"86"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"70"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.96","pValueComment":"a priori threshold for significance is 0.05.","statisticalMethod":"Likelihood Ratio Test","statisticalComment":"Likelihood Ratio Test from logistic regression analysis adjusting for clinical site."}]},{"type":"SECONDARY","title":"BDI-II","description":"Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 5 participants in the CBT arm and 2 participants in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.7","lowerLimit":"15.2","upperLimit":"22.2"},{"groupId":"OG001","value":"14.1","lowerLimit":"11.2","upperLimit":"17.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"-3.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.4","ciUpperLimit":"-0.02","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"GAD-7","description":"Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 4 participants in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.5","lowerLimit":"5.9","upperLimit":"9.2"},{"groupId":"OG001","value":"6.5","lowerLimit":"4.9","upperLimit":"8.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"-1.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.1","ciUpperLimit":"0.8","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Sheehan Disability Scale","description":"range 0-30, higher scores indicate worse disability","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 1 participant in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15.2","lowerLimit":"12.8","upperLimit":"17.6"},{"groupId":"OG001","value":"11.0","lowerLimit":"8.7","upperLimit":"13.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"-3.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.2","ciUpperLimit":"-0.1","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"SF-36 Energy/Vitality","description":"Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the CBT arm and 4 participants in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"49"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.2","lowerLimit":"33.4","upperLimit":"44.9"},{"groupId":"OG001","value":"53","lowerLimit":"45.7","upperLimit":"60.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"10.2","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.3","ciUpperLimit":"19.0","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Global Quality of Life Scale","description":"range 0-10, higher scores indicate better quality of life","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.6","lowerLimit":"5.0","upperLimit":"6.2"},{"groupId":"OG001","value":"6.4","lowerLimit":"5.8","upperLimit":"7.0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"0.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.2","ciUpperLimit":"1.4","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Satisfaction With Life Scale","description":"range 1-35, higher scores indicate better satisfaction","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.8","lowerLimit":"14.9","upperLimit":"18.6"},{"groupId":"OG001","value":"20.1","lowerLimit":"17.9","upperLimit":"22.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"2.6","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.1","ciUpperLimit":"5.1","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Perceived Social Support","description":"Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"51"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.7","lowerLimit":"4.3","upperLimit":"5.1"},{"groupId":"OG001","value":"4.6","lowerLimit":"4.2","upperLimit":"5.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.5","ciUpperLimit":"0.5","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"PSQI","description":"Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 11 participants in the CBT arm and 13 participants in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.5","lowerLimit":"8.1","upperLimit":"10.8"},{"groupId":"OG001","value":"6.8","lowerLimit":"5.5","upperLimit":"8.1"}]}]}]},{"type":"SECONDARY","title":"Exercise","description":"Single item activity measure, range 1-6, higher indicates less activity","populationDescription":"Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"52"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","lowerLimit":"3.1","upperLimit":"4.0"},{"groupId":"OG001","value":"3.2","lowerLimit":"2.8","upperLimit":"3.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"0.1","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.5","ciUpperLimit":"0.7","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Percentage of Dialysis Treatment Sessions Skipped and/or Shortened","description":"Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of sessions skipped/shortened","timeFrame":"Over 12 Weeks","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"58"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.2","lowerLimit":"16.4","upperLimit":"28.0"},{"groupId":"OG001","value":"17.3","lowerLimit":"13.0","upperLimit":"21.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Risk Ratio (RR)","paramValue":"0.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.55","ciUpperLimit":"1.10","estimateComment":"The mean difference estimate is from a negative binomial model adjusted for clinical site. It is the rate of sessions skipped/shortened in the Drug group (numerator) compared to CBT (denominator)."}]},{"type":"SECONDARY","title":"Percent Inter-dialytic Weight Gain","description":"Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study","populationDescription":"In addition to participants withdrawn / died, 11 participants were missing average weight gain at week 12: 3 in CBT arm and 8 in Drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of body weight","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"50"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.6","lowerLimit":"2.3","upperLimit":"3.0"},{"groupId":"OG001","value":"2.9","lowerLimit":"2.5","upperLimit":"3.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"-0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.54","ciUpperLimit":"0.34","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]},{"type":"SECONDARY","title":"Serum Phosphorus Level","description":"Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study.","populationDescription":"In addition to participants withdrawn / died, 8 participants were missing serum phosphorus level at week 12: 3 in CBT arm and 5 in Drug arm.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"mg/dl","timeFrame":"Week 12","groups":[{"id":"OG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization.\n\nIndividuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2)."},{"id":"OG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.1","lowerLimit":"5.6","upperLimit":"6.6"},{"groupId":"OG001","value":"6.3","lowerLimit":"5.9","upperLimit":"6.8"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Mean Difference (Final Values)","paramValue":"0.25","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.75","estimateComment":"The mean difference estimate is from longitudinal model adjusted for clinical site. It is the difference in scores between treatment groups (Drug - CBT) at 12 weeks. All participants are included in the longitudinal model (N=120)."}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Participants followed from randomization to treatment to 30 days after end of treatment period (4 months).","description":"Participants in the comparative efficacy trial (CBT-I or drug arms) were asked at each study visit if they had experienced any adverse events. Adverse events were not captured for participants in the observation arm or participants only randomized to engagement or control visit.","eventGroups":[{"id":"EG000","title":"Cognitive Behavioral Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Individuals will undergo 10 CBT sessions of 60 minutes each, by a trained therapist in the dialysis facility (8 weekly sessions; then every other week x 2).","deathsNumAffected":2,"deathsNumAtRisk":60,"seriousNumAffected":11,"seriousNumAtRisk":60,"otherNumAffected":4,"otherNumAtRisk":60},{"id":"EG001","title":"Antidepressant Drug Therapy","description":"The subjects will be randomly assigned to individual CBT or sertraline drug therapy using block randomization. Anti-Depressant Drug Therapy will be delivered with sertraline, a selective serotonin reuptake inhibitor, and the dose will be titrated using the Measurement Based Care Protocol.","deathsNumAffected":0,"deathsNumAtRisk":60,"seriousNumAffected":14,"seriousNumAtRisk":60,"otherNumAffected":12,"otherNumAtRisk":60}],"seriousEvents":[{"term":"Hypertension","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Afib","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Syncope","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Volume overload","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":60},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":60}]},{"term":"Cardiovascular event","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Fatal","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Cardiac arrest","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Rectal bleeding","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Hematemesis","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Small bowel obstruction","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Gastroparesis","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Cellulitis","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Catheter infection","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Healthcare-associated pneumonia","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Clostridium difficile infection","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Pneumonia","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Leg fracture","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Leg amputation","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Vertigo, facial palsy (shingles)","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Convulsions","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Vaginal bleeding","organSystem":"Reproductive system and breast disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Acute respiratory failure","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":60}]},{"term":"Dyspnea","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Kidney transplant","organSystem":"Surgical and medical procedures","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Arteriovenous grafts vascular access surgery","organSystem":"Surgical and medical procedures","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Leg ischemia","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]},{"term":"Arteriovenous graft malfunction","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Renal artery aneurysm","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":60}]},{"term":"Unknown System Organ Class","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Participant died at home","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":60},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":60}]}],"otherEvents":[{"term":"Dizziness","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":60}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":60},{"groupId":"EG001","numEvents":7,"numAffected":6,"numAtRisk":60}]},{"term":"Fatigue","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":60},{"groupId":"EG001","numEvents":6,"numAffected":5,"numAtRisk":60}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Tessa Rue, Biostatistician","organization":"Center for Biomedical Statistics, University of Washington","email":"ruet@uw.edu","phone":"206-543-4246"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2017-06-16","uploadDate":"2019-05-31T13:59","filename":"Prot_SAP_000.pdf","size":9957230}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D007676","term":"Kidney Failure, Chronic"},{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D019263","term":"Dysthymic Disorder"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D051436","term":"Renal Insufficiency, Chronic"},{"id":"D051437","term":"Renal Insufficiency"},{"id":"D007674","term":"Kidney Diseases"},{"id":"D014570","term":"Urologic Diseases"},{"id":"D052776","term":"Female Urogenital Diseases"},{"id":"D005261","term":"Female Urogenital Diseases and Pregnancy Complications"},{"id":"D000091642","term":"Urogenital Diseases"},{"id":"D052801","term":"Male Urogenital Diseases"},{"id":"D002908","term":"Chronic Disease"},{"id":"D020969","term":"Disease Attributes"},{"id":"D010335","term":"Pathologic Processes"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D015928","term":"Cognitive Behavioral Therapy"},{"id":"D020280","term":"Sertraline"}],"ancestors":[{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"},{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}