{"protocolSection":{"identificationModule":{"nctId":"NCT02424188","orgStudyIdInfo":{"id":"IRB00072510"},"secondaryIdInfos":[{"id":"R01MH104553","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH104553"}],"organization":{"fullName":"Johns Hopkins University","class":"OTHER"},"briefTitle":"Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH","officialTitle":"Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH","acronym":"TRIUMPH"},"statusModule":{"statusVerifiedDate":"2025-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-07-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-03","type":"ACTUAL"},"completionDateStruct":{"date":"2020-03","type":"ACTUAL"},"studyFirstSubmitDate":"2015-04-18","studyFirstSubmitQcDate":"2015-04-18","studyFirstPostDateStruct":{"date":"2015-04-22","type":"ESTIMATED"},"resultsFirstSubmitDate":"2025-04-09","resultsFirstSubmitQcDate":"2025-06-18","resultsFirstPostDateStruct":{"date":"2025-06-25","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-06-18","lastUpdatePostDateStruct":{"date":"2025-06-25","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Johns Hopkins University","class":"OTHER"},"collaborators":[{"name":"Massachusetts General Hospital","class":"OTHER"},{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will determine whether an 18-month practical tobacco smoking cessation program integrating weight management counseling and exercise will be superior to treatment as usual in achieving prolonged smoking abstinence in persons with serious mental illness.","detailedDescription":"The objective of this study is to perform a randomized clinical trial (TRIUMPH) in persons with serious mental illness to test the hypothesis that intervention participants will have higher rates of smoking abstinence at 18 months than participants in the treatment as usual arm. The intervention includes group and individual smoking cessation and weight management counseling tailored by a participant's readiness to quit, pharmacotherapy with either varenicline or buproprion plus nicotine replacement therapy prescribed in the community clinic, exercise, and text messaging supporting health behavior change."},"conditionsModule":{"conditions":["Mental Illness"],"keywords":["weight management","physical activity","Tobacco smoking","Serious mental illness"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":192,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"TRIUMPH intervention","type":"EXPERIMENTAL","description":"Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support","interventionNames":["Other: TRIIUMPH Intervention"]},{"label":"Treatment as Usual","type":"NO_INTERVENTION","description":"referral to quit line"}],"interventions":[{"type":"OTHER","name":"TRIIUMPH Intervention","description":"Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support","armGroupLabels":["TRIUMPH intervention"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Smoking Abstinence","description":"7-day point prevalence, biochemically validated","timeFrame":"measured at 18 months"}],"secondaryOutcomes":[{"measure":"Smoking Abstinence - 3 Months","description":"Participants with 3 month smoking abstinence","timeFrame":"from 15 to 18 months"},{"measure":"Smoking Abstinence","description":"7-day point prevalence, biochemically validated","timeFrame":"measured at 6 and 12 months"},{"measure":"12 Months Continuous Smoking Abstinence","description":"participants who reported smoking abstinence continuously from 6 months 18 months","timeFrame":"measured from 6 months to 18 months"},{"measure":"Weight","description":"weight in kilograms","timeFrame":"Baseline, 6 and 18 months"},{"measure":"Body Mass Index","timeFrame":"Baseline, 18 months"},{"measure":"Six Minute Walk","timeFrame":"18 months"},{"measure":"Framingham Stroke Risk Profile Score","description":"The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke","timeFrame":"18 months"},{"measure":"Health Status as Assessed by the Short Form -12 (SF-12) Index","description":"SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome","timeFrame":"6 and 18 months"},{"measure":"Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale","description":"Brief Psychiatric Rating Scale. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.","timeFrame":"Baseline"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness\n* Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available)\n* On stable psychotropic medication for mental illness for at least 30 days (i.e., antipsychotic medication for those with schizophrenia spectrum illness, mood stabilizer for those with bipolar disorder)\n* Competent and willing to give informed consent\n* Completion of baseline data collection\n* Willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids\n\nExclusion Criteria:\n\n* Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months\n* Serious unstable medical condition that limits life expectancy\n* Pregnant, breastfeeding, or planning a pregnancy during study period.\n* Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days\n* Planning to leave mental health program or move out of geographic area within 18 months Review by treating psychiatrist required for those with inpatient psychiatric hospitalization within six months of enrollment.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Gail L Daumit, MD, MHS","affiliation":"Johns Hopkins University","role":"PRINCIPAL_INVESTIGATOR"},{"name":"A. Eden Evins, MD, MPH","affiliation":"Massachussetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Johns Hopkins","city":"Baltimore","state":"Maryland","zip":"21287","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}}]},"referencesModule":{"references":[{"pmid":"37378972","type":"DERIVED","citation":"Daumit GL, Evins AE, Cather C, Dalcin AT, Dickerson FB, Miller ER 3rd, Appel LJ, Jerome GJ, McCann U, Ford DE, Charleston JB, Young DR, Gennusa JV 3rd, Goldsholl S, Cook C, Fink T, Wang NY. Effect of a Tobacco Cessation Intervention Incorporating Weight Management for Adults With Serious Mental Illness: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Sep 1;80(9):895-904. doi: 10.1001/jamapsychiatry.2023.1691."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"TRIUMPH Intervention","description":"Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support\n\nTRIIUMPH Intervention: Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support"},{"id":"FG001","title":"Treatment as Usual","description":"referral to quit line"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"95"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"90"}]},{"type":"NOT 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Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48","spread":"12.1"},{"groupId":"BG001","value":"51.3","spread":"11"},{"groupId":"BG002","value":"49.6","spread":"11.7"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"52"},{"groupId":"BG002","value":"97"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"43"},{"groupId":"BG002","value":"95"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]},{"title":"Not Hispanic or 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