{"protocolSection":{"identificationModule":{"nctId":"NCT00118430","orgStudyIdInfo":{"id":"R01MH071268","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH071268"},"secondaryIdInfos":[{"id":"R01MH071268","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH071268"}],"organization":{"fullName":"Indiana University","class":"OTHER"},"briefTitle":"Stepped Care for Depression and Musculoskeletal Pain","officialTitle":"Stepped Care for Affective Disorders and Musculoskeletal Pain"},"statusModule":{"statusVerifiedDate":"2017-03","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-09"},"primaryCompletionDateStruct":{"date":"2008-07","type":"ACTUAL"},"completionDateStruct":{"date":"2008-08","type":"ACTUAL"},"studyFirstSubmitDate":"2005-07-06","studyFirstSubmitQcDate":"2005-07-06","studyFirstPostDateStruct":{"date":"2005-07-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-05-23","resultsFirstSubmitQcDate":"2017-03-28","resultsFirstPostDateStruct":{"date":"2017-05-09","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-03-28","lastUpdatePostDateStruct":{"date":"2017-05-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Indiana University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.","detailedDescription":"In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The \"Stepped Care for Affective Disorders and Musculoskeletal Pain\" (SCAMP) study will determine the most effective treatment for patients with pain and depression.\n\nThis study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12.\n\nStudy hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients."},"conditionsModule":{"conditions":["Pain","Depression"],"keywords":["Back Pain","Knee Pain","Hip Pain","Stepped Care","Antidepressant","Relaxation Techniques","Exercise"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":500,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Stepped Care","type":"EXPERIMENTAL","description":"Stepped care group","interventionNames":["Behavioral: Stepped Care","Drug: Antidepressants"]},{"label":"Usual Care","type":"ACTIVE_COMPARATOR","description":"Treatment as usual group","interventionNames":["Drug: Usual Care"]},{"label":"No Treatment","type":"NO_INTERVENTION","description":"Participants without depression group"}],"interventions":[{"type":"BEHAVIORAL","name":"Stepped Care","description":"Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.","armGroupLabels":["Stepped Care"]},{"type":"DRUG","name":"Antidepressants","description":"Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg).","armGroupLabels":["Stepped Care"]},{"type":"DRUG","name":"Usual Care","description":"This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.","armGroupLabels":["Usual Care"],"otherNames":["Standard Care"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Brief Pain Inventory Interference","description":"The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).","timeFrame":"Measured at Year 1"},{"measure":"HSCL-20 Depression Severity","description":"This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)","timeFrame":"Measured at Year 1"}],"secondaryOutcomes":[{"measure":"Graded Chronic Pain Scale Disability Score","description":"This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)","timeFrame":"Measured at Year 1"},{"measure":"Primary Care Visits","timeFrame":"Measured at Year 1"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Moderate or severe pain in the back, hips, or knees for at least 3 months prior to study entry\n* History of or current use of at least one medication for pain\n* English-speaking\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment\n* Schizophrenia or other psychotic disorders\n* Receiving disability benefits for pain\n* Anticipated life expectancy less than 12 months\n* Pregnancy","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Kurt Kroenke, MD","affiliation":"Indiana University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Indiana University Medical Center","city":"Indianapolis","state":"Indiana","zip":"46202","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}}]},"referencesModule":{"references":[{"pmid":"21494337","type":"DERIVED","citation":"Dube P, Kurt K, Bair MJ, Theobald D, Williams LS. The p4 screener: evaluation of a brief measure for assessing potential suicide risk in 2 randomized effectiveness trials of primary care and oncology patients. Prim Care Companion J Clin Psychiatry. 2010;12(6):PCC.10m00978. doi: 10.4088/PCC.10m00978blu."},{"pmid":"19470987","type":"DERIVED","citation":"Kroenke K, Bair MJ, Damush TM, Wu J, Hoke S, Sutherland J, Tu W. Optimized antidepressant therapy and pain self-management in primary care patients with depression and musculoskeletal pain: a randomized controlled trial. JAMA. 2009 May 27;301(20):2099-110. doi: 10.1001/jama.2009.723."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Data has been published in multiple publications. Should others wish access to data for publication reasons, we are willing to share"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly with a physician-investigator to review cases, the physician-investigator will be available at all times to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response\n\nAntidepressants: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg"},{"id":"FG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."},{"id":"FG002","title":"No Treatment","description":"Participants without depression group"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"123"},{"groupId":"FG001","numSubjects":"127"},{"groupId":"FG002","numSubjects":"250"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"123 included in primary analysis due to repeated measures and interim 1,3 and 6 month assessments","numSubjects":"102"},{"groupId":"FG001","comment":"127 included in primary analysis due to repeated measures and interim 1,3 and 6 month assessments","numSubjects":"103"},{"groupId":"FG002","numSubjects":"222"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"28"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"28"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."},{"id":"BG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."},{"id":"BG002","title":"No Treatment","description":"Participants without depression group"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"127"},{"groupId":"BG002","value":"250"},{"groupId":"BG003","value":"500"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55.2","spread":"12.6"},{"groupId":"BG001","value":"55.8","spread":"11.1"},{"groupId":"BG002","value":"62.5","spread":"14.1"},{"groupId":"BG003","value":"59.0","spread":"13.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"69"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"127"},{"groupId":"BG003","value":"259"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"123"},{"groupId":"BG003","value":"241"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"49"},{"groupId":"BG002","value":"100"},{"groupId":"BG003","value":"191"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"140"},{"groupId":"BG003","value":"291"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"15"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"123"},{"groupId":"BG001","value":"127"},{"groupId":"BG002","value":"250"},{"groupId":"BG003","value":"500"}]}]}]},{"title":"HSCL-20 depression severity","description":"This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.8","spread":"0.7"},{"groupId":"BG001","value":"1.9","spread":"0.6"},{"groupId":"BG002","value":"0.7","spread":"0.5"},{"groupId":"BG003","value":"1.3","spread":"0.8"}]}]}]},{"title":"Brief Pain Inventory severity","description":"The BPI severity scale is a 4-item scale with each item scored from 0 (no pain) to 10 (worst pain imaginable). The scale score is the average of the 4 items and thus can range from 0 (no pain) to 10 (worst or more severe pain)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.2","spread":"1.8"},{"groupId":"BG001","value":"6.1","spread":"1.8"},{"groupId":"BG002","value":"5.4","spread":"1.8"},{"groupId":"BG003","value":"5.8","spread":"1.8"}]}]}]},{"title":"Brief Pain Inventory interference","description":"The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6.8","spread":"2.2"},{"groupId":"BG001","value":"7.1","spread":"2.0"},{"groupId":"BG002","value":"4.8","spread":"2.2"},{"groupId":"BG003","value":"5.9","spread":"2.4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Brief Pain Inventory Interference","description":"The BPI interference scale consists of 7 items, each scored from 0 (no interference) to 10 (complete interference), and the total score is the average of the 7 individual item scores. Therefore, the BPI interference score can range from 0 (lowest pain) to 10 (worst or highest pain).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Year 1","groups":[{"id":"OG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."},{"id":"OG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."},{"id":"OG002","title":"No Treatment","description":"Participants without depression group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.0","spread":"2.8"},{"groupId":"OG001","value":"6.5","spread":"2.4"},{"groupId":"OG002","value":"4.6","spread":"2.4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"This reported p-value was calculated (and does not merely represent the threshold for significance.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"PRIMARY","title":"HSCL-20 Depression Severity","description":"This scale consists of 20 items, each scored from 0 (lowest) to 4 (highest or worst). The scale score is the average of the 20 items. Therefore, the HSCL-20 depression severity score can range from 0 (no depression) to 4 (highest or worst depression)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Year 1","groups":[{"id":"OG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."},{"id":"OG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."},{"id":"OG002","title":"No Treatment","description":"Participants without depression group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"0.7"},{"groupId":"OG001","value":"1.7","spread":"0.7"},{"groupId":"OG002","value":"0.8","spread":"0.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"< 0.001","pValueComment":"This reported p-value was calculated (and does not merely represent the threshold for significance.","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Graded Chronic Pain Scale Disability Score","description":"This scale ranges from 0 (no pain-specific disability) to 100 (highest or worst pain-specific disability)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Year 1","groups":[{"id":"OG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."},{"id":"OG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."},{"id":"OG002","title":"No Treatment","description":"Participants without depression group"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"127"},{"groupId":"OG002","value":"250"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"52.5","spread":"31.6"},{"groupId":"OG001","value":"66.1","spread":"27.3"},{"groupId":"OG002","value":"44.8","spread":"29.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Mixed Models Analysis"}]},{"type":"SECONDARY","title":"Primary Care Visits","populationDescription":"The no treatment group did not have depression and was followed simply as a cohort and not part of the clinical trial. Therefore we did not measure this secondary outcome of primary care visits in the no treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"number of primary care visits","timeFrame":"Measured at Year 1","groups":[{"id":"OG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline."},{"id":"OG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"127"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.3","spread":"5.8"},{"groupId":"OG001","value":"5.9","spread":"5.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Poisson"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","description":"The no treatment group did not have depression and was simply followed as a cohort and were not part of the actual clinical trial. Thus, adverse events were not assessed in this group.","eventGroups":[{"id":"EG000","title":"Stepped Care","description":"Stepped care group\n\nStepped Care: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response.\n\nAntidepressants: Participants will be assigned to optimization of venlafaxine, duloxetine, fluoxetine, sertraline, citalopram, paroxetine, or nortriptyline.","seriousNumAffected":0,"seriousNumAtRisk":123,"otherNumAffected":0,"otherNumAtRisk":123},{"id":"EG001","title":"Usual Care","description":"Treatment as usual group\n\nUsual Care: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.","seriousNumAffected":0,"seriousNumAtRisk":127,"otherNumAffected":0,"otherNumAtRisk":127}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Kurt Kroenke","organization":"Indiana University","email":"kkroenke@regenstrief.org","phone":"3172749046"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D010146","term":"Pain"},{"id":"D003863","term":"Depression"},{"id":"D001416","term":"Back Pain"},{"id":"D009043","term":"Motor Activity"}],"ancestors":[{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000928","term":"Antidepressive Agents"},{"id":"D059039","term":"Standard of Care"}],"ancestors":[{"id":"D011619","term":"Psychotropic Drugs"},{"id":"D002491","term":"Central Nervous System Agents"},{"id":"D045506","term":"Therapeutic Uses"},{"id":"D020228","term":"Pharmacologic Actions"},{"id":"D020164","term":"Chemical Actions and Uses"},{"id":"D019984","term":"Quality Indicators, Health Care"},{"id":"D011787","term":"Quality of Health Care"},{"id":"D006298","term":"Health Services Administration"},{"id":"D017530","term":"Health Care Quality, Access, and Evaluation"}]}},"hasResults":true}