{"protocolSection":{"identificationModule":{"nctId":"NCT03534284","orgStudyIdInfo":{"id":"STUDY00004678"},"secondaryIdInfos":[{"id":"R01DK115468","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DK115468"}],"organization":{"fullName":"University of Washington","class":"OTHER"},"briefTitle":"Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis","officialTitle":"Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)","acronym":"Sleep-HD"},"statusModule":{"statusVerifiedDate":"2024-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-09-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-10-17","type":"ACTUAL"},"completionDateStruct":{"date":"2022-11-17","type":"ACTUAL"},"studyFirstSubmitDate":"2018-05-01","studyFirstSubmitQcDate":"2018-05-11","studyFirstPostDateStruct":{"date":"2018-05-23","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-01-08","resultsFirstSubmitQcDate":"2024-02-02","resultsFirstPostDateStruct":{"date":"2024-02-05","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-02-02","lastUpdatePostDateStruct":{"date":"2024-02-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Rajnish Mehrotra","investigatorTitle":"Section Head Nephrology, School of Medicine: Department of Medicine","investigatorAffiliation":"University of Washington"},"leadSponsor":{"name":"University of Washington","class":"OTHER"},"collaborators":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months.\n\nThe SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo).\n\n126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).","detailedDescription":"Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments.\n\nThere is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients.\n\nSLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo."},"conditionsModule":{"conditions":["Insomnia","End Stage Renal Disease"],"keywords":["Hemodialysis","Kidney disease","Trazodone","Cognitive behavioral therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","maskingDescription":"The investigator, the participant, and the care provider will be blinded to the drug assignment (trazodone vs. placebo) for those subjects randomized into the medication intervention arm.","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR"]}},"enrollmentInfo":{"count":126,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"CBT-I","type":"ACTIVE_COMPARATOR","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.","interventionNames":["Behavioral: Cognitive Behavioral Therapy for Insomnia"]},{"label":"Medication- Trazodone","type":"ACTIVE_COMPARATOR","description":"Trazodone (50-100 mg):","interventionNames":["Drug: Trazodone"]},{"label":"Medication- Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo (for trazodone)","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy for Insomnia","description":"Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.","armGroupLabels":["CBT-I"],"otherNames":["CBT-I"]},{"type":"DRUG","name":"Trazodone","description":"trazodone tablet","armGroupLabels":["Medication- Trazodone"],"otherNames":["Desyrel"]},{"type":"DRUG","name":"Placebo","description":"Inactive pill manufactured to mimic trazodone tablets.","armGroupLabels":["Medication- Placebo"],"otherNames":["Placebo (for trazodone)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Insomnia Severity Index (ISI) Short-term","description":"summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Insomnia Severity Index (ISI) Long-term","description":"summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"}],"secondaryOutcomes":[{"measure":"Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term","description":"Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term","description":"Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term","description":"Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term","description":"Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term","description":"Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term","description":"Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term","description":"Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term","description":"Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term","description":"Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term","description":"Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term","description":"Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term","description":"Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term","description":"Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term","description":"Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term","description":"Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term","description":"Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term","description":"Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term","description":"Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Cumulative Weekly Use of Sedatives/Hypnotics - Short-term","description":"This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Cumulative Weekly Use of Sedatives/Hypnotics - Long-term","description":"This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"},{"measure":"Objective Measure of Sleep - Short-term","description":"Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention","timeFrame":"Week 7"},{"measure":"Objective Measure of Sleep - Long-term","description":"Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention","timeFrame":"Week 25"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months\n* Able to speak English\n* ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months\n\nExclusion Criteria:\n\n* Severe cognitive impairment on Mini-COG cognitive test (score \\< 3)\n* Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9\n* Suicidal Ideation\n* Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score \\> 5)\n* Severe restless leg syndrome\n* Treatment with trazodone in the past one month\n* Known allergy to trazodone (self-report or by chart review)\n* Current treatment with monoamine oxidase inhibitors or in the preceding 14 days\n* Current treatment with linezolid (self-report or by chart review)\n* Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics\n* Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control\n* Life Expectancy \\< 3 months\n* Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months\n* Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Raj Mehrotra, MD","affiliation":"University of Washington","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Northwest Kidney Centers","city":"Seattle","state":"Washington","zip":"98122","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"38224591","type":"DERIVED","citation":"Mehrotra R, Cukor D, McCurry SM, Rue T, Roumelioti ME, Heagerty PJ, Unruh M. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188. doi: 10.7326/M23-1794. Epub 2024 Jan 16."},{"pmid":"33081705","type":"DERIVED","citation":"Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"126 participants completed baseline measures before group assignment, including patient reported outcomes collected via Computer Assisted Telephone Interview (CATI) and nights using sleep aid on sedatives\\&hypnotics CRF. Most (115) also completed baseline Actigraphy, although this was not required for study entry (randomization).","recruitmentDetails":"923 patients screened with Insomnia Severity Index (ISI). Of 411 identified as having insomnia (ISI score \\>=10),179 declined study participation and 106 met exclusion criteria.","groups":[{"id":"FG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"FG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"FG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"41"}]},{"type":"Week 7 Primary Outcome","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"40"}]},{"type":"COMPLETED","comment":"Week 25 primary outcome","achievements":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"39"},{"groupId":"FG002","numSubjects":"38"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"BG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"BG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"41"},{"groupId":"BG003","value":"126"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"60.9","spread":"15.2"},{"groupId":"BG001","value":"56.2","spread":"13.4"},{"groupId":"BG002","value":"57.2","spread":"12.7"},{"groupId":"BG003","value":"58.1","spread":"13.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"63"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"63"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"26"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"33"},{"groupId":"BG003","value":"100"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"7"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"8"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"27"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"78"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Time since starting dialysis, months","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"months","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"26.4","lowerLimit":"15.8","upperLimit":"45.7"},{"groupId":"BG001","value":"36.3","lowerLimit":"19.6","upperLimit":"58.2"},{"groupId":"BG002","value":"28.2","lowerLimit":"14.0","upperLimit":"52.5"},{"groupId":"BG003","value":"30.9","lowerLimit":"15.5","upperLimit":"52.4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Insomnia Severity Index (ISI) Short-term","description":"summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.47","lowerLimit":"10.68","upperLimit":"14.26"},{"groupId":"OG001","value":"11.97","lowerLimit":"10.23","upperLimit":"13.72"},{"groupId":"OG002","value":"13.05","lowerLimit":"11.29","upperLimit":"14.82"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Null hypothesis: average CBT-I=Trazodone=Placebo at week 7","nonInferiorityType":"SUPERIORITY","pValue":"0.6761","pValueComment":"0.05 threshold for significance; no adjustment for multiple comparisons","statisticalMethod":"Mixed Models Analysis"}]},{"type":"PRIMARY","title":"Insomnia Severity Index (ISI) Long-term","description":"summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11.34","lowerLimit":"9.28","upperLimit":"13.41"},{"groupId":"OG001","value":"12.2","lowerLimit":"10.2","upperLimit":"14.19"},{"groupId":"OG002","value":"11.85","lowerLimit":"9.83","upperLimit":"13.88"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"Null hypothesis: average CBT-I=Trazodone=Placebo at week 25","nonInferiorityType":"SUPERIORITY","pValue":"0.8375","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term","description":"Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.44","lowerLimit":"8.32","upperLimit":"10.55"},{"groupId":"OG001","value":"11.09","lowerLimit":"10","upperLimit":"12.18"},{"groupId":"OG002","value":"12.39","lowerLimit":"11.28","upperLimit":"13.49"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term","description":"Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.15","lowerLimit":"7.89","upperLimit":"10.4"},{"groupId":"OG001","value":"10.49","lowerLimit":"9.26","upperLimit":"11.71"},{"groupId":"OG002","value":"9.95","lowerLimit":"8.71","upperLimit":"11.19"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term","description":"Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.67","lowerLimit":"6.37","upperLimit":"8.97"},{"groupId":"OG001","value":"8.46","lowerLimit":"7.19","upperLimit":"9.74"},{"groupId":"OG002","value":"7.5","lowerLimit":"6.21","upperLimit":"8.79"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term","description":"Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.27","lowerLimit":"5.88","upperLimit":"8.65"},{"groupId":"OG001","value":"8.12","lowerLimit":"6.76","upperLimit":"9.47"},{"groupId":"OG002","value":"7.94","lowerLimit":"6.57","upperLimit":"9.31"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term","description":"Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32.55","lowerLimit":"29.51","upperLimit":"35.59"},{"groupId":"OG001","value":"28.76","lowerLimit":"25.77","upperLimit":"31.75"},{"groupId":"OG002","value":"28.5","lowerLimit":"25.48","upperLimit":"31.51"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term","description":"Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32.65","lowerLimit":"29.44","upperLimit":"35.86"},{"groupId":"OG001","value":"28.53","lowerLimit":"25.39","upperLimit":"31.68"},{"groupId":"OG002","value":"30.7","lowerLimit":"27.52","upperLimit":"33.87"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term","description":"Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.50","lowerLimit":"3.74","upperLimit":"5.27"},{"groupId":"OG001","value":"4.53","lowerLimit":"3.78","upperLimit":"5.29"},{"groupId":"OG002","value":"4.21","lowerLimit":"3.44","upperLimit":"4.98"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term","description":"Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.14","lowerLimit":"3.34","upperLimit":"4.95"},{"groupId":"OG001","value":"4.32","lowerLimit":"3.53","upperLimit":"5.11"},{"groupId":"OG002","value":"4.80","lowerLimit":"4.00","upperLimit":"5.60"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term","description":"Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.18","lowerLimit":"3.32","upperLimit":"5.05"},{"groupId":"OG001","value":"4.07","lowerLimit":"3.22","upperLimit":"4.91"},{"groupId":"OG002","value":"3.61","lowerLimit":"2.75","upperLimit":"4.46"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term","description":"Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.88","lowerLimit":"3.07","upperLimit":"4.68"},{"groupId":"OG001","value":"3.71","lowerLimit":"2.93","upperLimit":"4.50"},{"groupId":"OG002","value":"4.30","lowerLimit":"3.50","upperLimit":"5.09"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term","description":"Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.98","lowerLimit":"5.47","upperLimit":"8.49"},{"groupId":"OG001","value":"7.93","lowerLimit":"6.45","upperLimit":"9.40"},{"groupId":"OG002","value":"8.27","lowerLimit":"6.78","upperLimit":"9.75"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term","description":"Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.61","lowerLimit":"5.09","upperLimit":"8.14"},{"groupId":"OG001","value":"8.04","lowerLimit":"6.55","upperLimit":"9.53"},{"groupId":"OG002","value":"7.34","lowerLimit":"5.83","upperLimit":"8.84"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term","description":"Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.18","lowerLimit":"3.54","upperLimit":"6.82"},{"groupId":"OG001","value":"6.18","lowerLimit":"4.58","upperLimit":"7.79"},{"groupId":"OG002","value":"7.04","lowerLimit":"5.42","upperLimit":"8.66"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term","description":"Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 25","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform."},{"id":"OG001","title":"Medication- Trazodone","description":"Trazodone (50-100 mg):\n\nTrazodone: trazodone tablet"},{"id":"OG002","title":"Medication- Placebo","description":"Placebo (for trazodone)\n\nPlacebo: Inactive pill manufactured to mimic trazodone tablets."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"41"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.27","lowerLimit":"3.56","upperLimit":"6.98"},{"groupId":"OG001","value":"6.35","lowerLimit":"4.67","upperLimit":"8.02"},{"groupId":"OG002","value":"6.29","lowerLimit":"4.60","upperLimit":"7.99"}]}]}]},{"type":"SECONDARY","title":"Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term","description":"Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention","populationDescription":"The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"score on a scale","timeFrame":"Week 7","groups":[{"id":"OG000","title":"CBT-I","description":"Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.\n\nCognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. 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