Mental IllnessTRIUMPHNCT02424188
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
A study testing TRIIUMPH Intervention in people with Mental Illness, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mental Illness
- What is being tested?
- TRIIUMPH Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness
- Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available)
- 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)
- Competent and willing to give informed consent
- Completion of baseline data collection
- Willing to participate in smoking cessation intervention that includes combination of evidence-based behavioral (group and individual sessions) and pharmacotherapeutic smoking cessation aids
Who cannot join
- Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months
- Serious unstable medical condition that limits life expectancy
- Pregnant, breastfeeding, or planning a pregnancy during study period.
- Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Mental Illness
- Being tested
- TRIIUMPH Intervention
- Keywords
- weight management, physical activity, Tobacco smoking, Serious mental illness
- Medical subject headings
- Mental Disorders, Motor Activity, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIIUMPH InterventionOther
Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support
| Study group | Role | What they receive |
|---|---|---|
| TRIUMPH intervention | Experimental | Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support Receives: Other: TRIIUMPH Intervention |
| Treatment as Usual | No intervention | referral to quit line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Smoking Abstinence
7-day point prevalence, biochemically validated
Measured: measured at 18 months
Secondary outcomes (9)
Smoking Abstinence - 3 Months
Participants with 3 month smoking abstinence
Measured: from 15 to 18 months
Smoking Abstinence
7-day point prevalence, biochemically validated
Measured: measured at 6 and 12 months
12 Months Continuous Smoking Abstinence
participants who reported smoking abstinence continuously from 6 months 18 months
Measured: measured from 6 months to 18 months
Weight
weight in kilograms
Measured: Baseline, 6 and 18 months
Body Mass Index
Measured: Baseline, 18 months
Six Minute Walk
Measured: 18 months
Framingham Stroke Risk Profile Score
The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Measured: 18 months
Health Status as Assessed by the Short Form -12 (SF-12) Index
SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome
Measured: 6 and 18 months
Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start7 Jul 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gail L Daumit, MD, MHS, Principal investigator, Johns Hopkins UniversityA. Eden Evins, MD, MPH, Principal investigator, Massachussetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424188
- Sponsor's protocol ID
- IRB00072510
- Other IDs
- R01MH104553
- Acronym
- TRIUMPH
- Status last verified
- Jun 2025
- First submitted
- 18 Apr 2015
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 37378972
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
- ClinicalTrials.gov ID
- NCT02424188
- Acronym / sponsor ID
- TRIUMPH / IRB00072510
- Conditions
- Mental Illness
- Keywords
- weight management, physical activity, Tobacco smoking, Serious mental illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, National Institute of Mental Health (NIMH)
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRIUMPH intervention | Experimental | Other: TRIIUMPH InterventionGroup and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support |
| Treatment as Usual | No intervention | –referral to quit line |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression meeting criteria for serious mental illness
- Fagerstrom Test for Nicotine Dependence of ≥3 and daily cigarette smoking for at least the past 6 months (on days that cigarettes were available)
- 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)
- Competent and willing to give informed consent
- Completion of baseline data collection
Key exclusion criteria (5 listed)
- Serious cardiovascular event (e.g. myocardial infarction, stroke) within the past 6 months
- Serious unstable medical condition that limits life expectancy
- Pregnant, breastfeeding, or planning a pregnancy during study period.
- Alcohol or illicit substance use disorder if not sober/abstinent for ≥ 30 days
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIIUMPH InterventionGroup and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support | Other | TRIUMPH intervention |
Primary outcome
Number of Participants With Smoking Abstinence
Time frame: measured at 18 months
7-day point prevalence, biochemically validated
9 secondary outcomes
Smoking Abstinence - 3 Months
Time frame: from 15 to 18 months
Smoking Abstinence
Time frame: measured at 6 and 12 months
12 Months Continuous Smoking Abstinence
Time frame: measured from 6 months to 18 months
Weight
Time frame: Baseline, 6 and 18 months
Body Mass Index
Time frame: Baseline, 18 months
Six Minute Walk
Time frame: 18 months
Framingham Stroke Risk Profile Score
Time frame: 18 months
Health Status as Assessed by the Short Form -12 (SF-12) Index
Time frame: 6 and 18 months
Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37378972Daumit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail L Daumit, MD, MHS principal investigator
Johns Hopkins University
A. Eden Evins, MD, MPH principal investigator
Massachussetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRIIUMPH Intervention in people with Mental Illness, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Smoking Abstinence (time frame: measured at 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02424188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.