{"protocolSection":{"identificationModule":{"nctId":"NCT00127673","orgStudyIdInfo":{"id":"R01MH066347","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH066347"},"secondaryIdInfos":[{"id":"R01MH066348","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH066348"}],"organization":{"fullName":"Case Western Reserve University","class":"OTHER"},"briefTitle":"Comparison of Two Treatments for Post-Traumatic Stress Disorder","officialTitle":"Effectiveness of PTSD Treatment: CBT Versus Sertraline"},"statusModule":{"statusVerifiedDate":"2022-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-09"},"primaryCompletionDateStruct":{"date":"2011-08","type":"ACTUAL"},"completionDateStruct":{"date":"2011-08","type":"ACTUAL"},"studyFirstSubmitDate":"2005-08-05","studyFirstSubmitQcDate":"2005-08-05","studyFirstPostDateStruct":{"date":"2005-08-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-07-11","resultsFirstSubmitQcDate":"2022-04-28","resultsFirstPostDateStruct":{"date":"2022-05-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2022-04-28","lastUpdatePostDateStruct":{"date":"2022-05-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Norah Feeny","investigatorTitle":"Professor","investigatorAffiliation":"Case Western Reserve University"},"leadSponsor":{"name":"Case Western Reserve University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.","detailedDescription":"Exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. PTSD is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. Both CBT and antidepressant therapy have been shown to effectively treat PTSD symptoms; however, comparisons of the treatments are limited. This study will compare the short- and long-term effectiveness of CBT and the antidepressant sertraline.\n\nParticipants will either be randomly assigned to CBT or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. Participants in the CBT group will have 10 weekly sessions of therapy. During the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. Participants will also be encouraged to practice the techniques learned in therapy in everyday life. Participants in the antidepressant group will take sertraline daily for 10 weeks. These participants will be seen weekly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. The medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. At the end of 10 weeks, participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months. Participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks. Self-report scales and questionnaires will be used to assess participants' PTSD symptoms, depression, anxiety, and social functioning. These assessments will occur at 3, 6, 12, and 24 months after the study treatment period."},"conditionsModule":{"conditions":["Post-Traumatic Stress Disorder"],"keywords":["Antidepressants","Cognitive behavior therapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":200,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"CBT no choice","type":"ACTIVE_COMPARATOR","description":"Participants will receive no choice cognitive behavioral therapy (CBT no choice)","interventionNames":["Behavioral: Cognitive behavioral therapy (CBT)"]},{"label":"CBT choice","type":"ACTIVE_COMPARATOR","description":"Participants will receive choice cognitive behavioral therapy (CBT choice)","interventionNames":["Behavioral: Cognitive behavioral therapy (CBT)"]},{"label":"sertraline no choice","type":"ACTIVE_COMPARATOR","description":"Participants will receive no choice sertraline (sertraline no choice)","interventionNames":["Drug: Sertraline"]},{"label":"sertraline choice","type":"ACTIVE_COMPARATOR","description":"Participants will receive choice sertraline (sertraline choice)","interventionNames":["Drug: Sertraline"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.","armGroupLabels":["sertraline choice","sertraline no choice"],"otherNames":["Zoloft"]},{"type":"BEHAVIORAL","name":"Cognitive behavioral therapy (CBT)","description":"CBT will include 10 weekly sessions of individual cognitive behavioral therapy.","armGroupLabels":["CBT choice","CBT no choice"],"otherNames":["Prolonged exposure (PE)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"PTSD Symptoms","description":"total score, range from 0-80, higher scores are more severe","timeFrame":"Post-treatment, ten weeks"},{"measure":"Depression Symptoms","description":"Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression","timeFrame":"Measured at Post-Treatment, at 10 weeks"},{"measure":"State Anxiety","description":"State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe","timeFrame":"Measured at Post-Treatment, at 10 weeks"}],"secondaryOutcomes":[{"measure":"Quality of Life Functioning","description":"Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment","timeFrame":"Measured at Post-Treatment, at 10 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* DSM-IV diagnosis of PTSD\n* Experienced traumatic event at least 12 weeks prior to study entry\n* Willingness to discontinue current CBT or antidepressant treatment\n\nExclusion Criteria:\n\n* Current diagnosis of schizophrenia or delusional disorder\n* Medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment\n* Current diagnosis of alcohol or substance dependence within 3 months prior to study entry\n* Ongoing intimate relationship with the perpetrator of the traumatic event\n* History of nonresponse to either CBT or sertraline\n* Medical contraindication for sertraline","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Norah C. Feeny, PhD","affiliation":"Department of Psychology, Case Western Reserve University","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Lori A. Zoellner, PhD","affiliation":"Department of Psychology, University of Washington","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Department of Psychology, University of Washington","city":"Seattle","state":"Washington","zip":"98195","country":"United States","geoPoint":{"lat":47.60621,"lon":-122.33207}}]},"referencesModule":{"references":[{"pmid":"39509231","type":"DERIVED","citation":"Gauthier GM, PeConga EK, Mohr JL, Feeny NC, Zoellner LA. Prospective stability of memory for peritraumatic dissociation and anxiety: Replication and extension examining PTSD treatment modality and response. Psychol Trauma. 2025 Feb;17(2):429-437. doi: 10.1037/tra0001790. Epub 2024 Nov 7."},{"pmid":"34672659","type":"DERIVED","citation":"Rosencrans PL, Zoellner LA, Feeny NC. A network approach to posttraumatic stress disorder: Comparing interview and self-report networks. Psychol Trauma. 2024 Feb;16(2):340-346. doi: 10.1037/tra0001151. Epub 2021 Oct 21."},{"pmid":"32662191","type":"DERIVED","citation":"Graham B, Garcia NM, Bergman HE, Feeny NC, Zoellner LA. Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning. J Trauma Stress. 2020 Aug;33(4):488-499. doi: 10.1002/jts.22570. Epub 2020 Jul 13."},{"pmid":"30336702","type":"DERIVED","citation":"Zoellner LA, Roy-Byrne PP, Mavissakalian M, Feeny NC. Doubly Randomized Preference Trial of Prolonged Exposure Versus Sertraline for Treatment of PTSD. Am J Psychiatry. 2019 Apr 1;176(4):287-296. doi: 10.1176/appi.ajp.2018.17090995. Epub 2018 Oct 19."},{"pmid":"29541927","type":"DERIVED","citation":"Le QA, Doctor JN, Zoellner LA, Feeny NC. Effects of treatment, choice, and preference on health-related quality-of-life outcomes in patients with posttraumatic stress disorder (PTSD). Qual Life Res. 2018 Jun;27(6):1555-1562. doi: 10.1007/s11136-018-1833-4. Epub 2018 Mar 14."},{"pmid":"24717377","type":"DERIVED","citation":"Le QA, Doctor JN, Zoellner LA, Feeny NC. Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder (the Optimizing PTSD Treatment Trial): a doubly randomized preference trial. J Clin Psychiatry. 2014 Mar;75(3):222-30. doi: 10.4088/JCP.13m08719."},{"pmid":"23587015","type":"DERIVED","citation":"Le QA, Doctor JN, Zoellner LA, Feeny NC. Minimal clinically important differences for the EQ-5D and QWB-SA in Post-traumatic Stress Disorder (PTSD): results from a Doubly Randomized Preference Trial (DRPT). Health Qual Life Outcomes. 2013 Apr 12;11:59. doi: 10.1186/1477-7525-11-59."}],"seeAlsoLinks":[{"label":"Click here for more information about the effectiveness of CBT and sertraline for PTSD","url":"http://faculty.washington.edu/zoellner/PTSDTx.htm"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"NoChoice_CBT","description":"Participants will receive no choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"FG001","title":"Choice_CBT","description":"Participants will receive choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"FG002","title":"NoChoice_SER","description":"Participants will receive no choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"FG003","title":"Choice_SER","description":"Participants will receive choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"48"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"55"},{"groupId":"FG003","numSubjects":"36"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"35"},{"groupId":"FG003","numSubjects":"25"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"20"},{"groupId":"FG003","numSubjects":"11"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Intent-to-treat","groups":[{"id":"BG000","title":"NoChoice_CBT","description":"Participants will receive no choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"BG001","title":"Choice_CBT","description":"Participants will receive choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"BG002","title":"NoChoice_SER","description":"Participants will receive no choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"BG003","title":"Choice_SER","description":"Participants will receive choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"55"},{"groupId":"BG003","value":"36"},{"groupId":"BG004","value":"200"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.2","spread":"11.4"},{"groupId":"BG001","value":"37.1","spread":"11.3"},{"groupId":"BG002","value":"38.9","spread":"11.3"},{"groupId":"BG003","value":"38.3","spread":"11.4"},{"groupId":"BG004","value":"36.60","spread":"11.30"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"152"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"48"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"10"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"52"},{"groupId":"BG003","value":"33"},{"groupId":"BG004","value":"190"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"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":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"5"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"10"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"43"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"38"},{"groupId":"BG003","value":"24"},{"groupId":"BG004","value":"130"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"11"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"PTSD Symptoms","description":"total score, range from 0-80, higher scores are more severe","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Post-treatment, ten weeks","groups":[{"id":"OG000","title":"CBT no Choice","description":"Participants will receive no choice cognitive behavioral therapy (CBT no choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG001","title":"CBT Choice","description":"Participants will receive choice cognitive behavioral therapy (CBT choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG002","title":"Sertraline no Choice","description":"Participants will receive no choice sertraline (sertraline no choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"OG003","title":"Sertraline Choice","description":"Participants will receive choice sertraline (sertraline choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.02","spread":"10.27"},{"groupId":"OG001","value":"10.87","spread":"8.75"},{"groupId":"OG002","value":"15.12","spread":"14.03"},{"groupId":"OG003","value":"10.78","spread":"7.59"}]}]}]},{"type":"PRIMARY","title":"Depression Symptoms","description":"Hamilton Depression Rating Scale (HAMD), total score, scoring range 0-50, with higher scores more severe depression","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Post-Treatment, at 10 weeks","groups":[{"id":"OG000","title":"CBT no Choice","description":"Participants will receive no choice cognitive behavioral therapy (CBT no choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG001","title":"CBT Choice","description":"Participants will receive choice cognitive behavioral therapy (CBT choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG002","title":"Sertraline no Choice","description":"Participants will receive no choice sertraline (sertraline no choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"OG003","title":"Sertraline Choice","description":"Participants will receive choice sertraline (sertraline choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10.33","spread":"10.33"},{"groupId":"OG001","value":"12.13","spread":"8.67"},{"groupId":"OG002","value":"15.24","spread":"13.90"},{"groupId":"OG003","value":"12.11","spread":"10.12"}]}]}]},{"type":"PRIMARY","title":"State Anxiety","description":"State-Trait Anxiety Inventory - State version, total score, scoring range, 0-63, with higher scores more severe","populationDescription":"Completer analysis","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Post-Treatment, at 10 weeks","groups":[{"id":"OG000","title":"NoChoice_CBT","description":"Participants will receive no choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG001","title":"Choice_CBT","description":"Participants will receive choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG002","title":"NoChoice_SER","description":"Participants will receive no choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"OG003","title":"Choice_SER","description":"Participants will receive choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.16","spread":"13.83"},{"groupId":"OG001","value":"38.79","spread":"13.13"},{"groupId":"OG002","value":"46.89","spread":"18.91"},{"groupId":"OG003","value":"38.72","spread":"12.48"}]}]}]},{"type":"SECONDARY","title":"Quality of Life Functioning","description":"Sheehan Disability Scale (SDS), total score, scoring range 0-30 , higher scores indicative of worse functional impairment","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"Measured at Post-Treatment, at 10 weeks","groups":[{"id":"OG000","title":"CBT no Choice","description":"Participants will receive no choice cognitive behavioral therapy (CBT no choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG001","title":"CBT Choice","description":"Participants will receive choice cognitive behavioral therapy (CBT choice)\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy."},{"id":"OG002","title":"Sertraline no Choice","description":"Participants will receive no choice sertraline (sertraline no choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."},{"id":"OG003","title":"Sertraline Choice","description":"Participants will receive choice sertraline (sertraline choice)\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"33"},{"groupId":"OG003","value":"27"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.82","spread":"6.24"},{"groupId":"OG001","value":"11.68","spread":"8.23"},{"groupId":"OG002","value":"14.06","spread":"10.38"},{"groupId":"OG003","value":"10.78","spread":"9.40"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Approximately 4 months","description":"After randomization through acute treatment until post-treatment assessment","eventGroups":[{"id":"EG000","title":"NoChoice_CBT","description":"Participants will receive no choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.","seriousNumAffected":1,"seriousNumAtRisk":48,"otherNumAffected":2,"otherNumAtRisk":48},{"id":"EG001","title":"Choice_CBT","description":"Participants will receive choice cognitive behavioral therapy\n\nCognitive behavioral therapy (CBT): CBT will include 10 weekly sessions of individual cognitive behavioral therapy.","seriousNumAffected":2,"seriousNumAtRisk":61,"otherNumAffected":3,"otherNumAtRisk":61},{"id":"EG002","title":"NoChoice_SER","description":"Participants will receive no choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.","seriousNumAffected":0,"seriousNumAtRisk":55,"otherNumAffected":4,"otherNumAtRisk":55},{"id":"EG003","title":"Choice_SER","description":"Participants will receive choice sertraline\n\nSertraline: The dose of sertraline will be up to 200 mg daily for 10 weeks. There will also be weekly meetings with study psychiatrist.","seriousNumAffected":0,"seriousNumAtRisk":36,"otherNumAffected":5,"otherNumAtRisk":36}],"seriousEvents":[{"term":"Chest pain/shortness of breath","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":48},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":36}]},{"term":"Kidney Stones","organSystem":"Surgical and medical procedures","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":36}]},{"term":"Motor Vehicle Accident","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":36}]}],"otherEvents":[{"term":"Headache/dizziness","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":55},{"groupId":"EG003","numEvents":6,"numAffected":2,"numAtRisk":36}]},{"term":"Gastrointestinal discomfort","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":55},{"groupId":"EG003","numEvents":3,"numAffected":2,"numAtRisk":36}]},{"term":"Delayed ejaculation","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":48},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":61},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":55},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":36}]},{"term":"Urinary hesitancy","organSystem":"Renal and urinary 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