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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH104553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Treatment as Usual | No Intervention | referral to quit line |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRIIUMPH Intervention | Other | Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Smoking Abstinence | 7-day point prevalence, biochemically validated | measured at 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence - 3 Months | Participants with 3 month smoking abstinence | from 15 to 18 months |
| Smoking Abstinence | 7-day point prevalence, biochemically validated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail L Daumit, MD, MHS | Johns Hopkins University | Principal Investigator |
| A. Eden Evins, MD, MPH | Massachussetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37378972 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TRIUMPH 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 TRIIUMPH 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 |
| FG001 | Treatment as Usual | referral to quit line |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | TRIUMPH 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 TRIIUMPH 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Smoking Abstinence | 7-day point prevalence, biochemically validated | Posted | Count of Participants | Participants | measured at 18 months |
|
Up to 18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TRIUMPH 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 TRIIUMPH 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric hospitalization | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Daumit, MD, MHS | Johns Hopkins University School of Medicine | 410-614-6460 | gdaumit@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2020 | Apr 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012907 | Smoking |
| D064424 | Tobacco Use |
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| measured at 6 and 12 months |
| 12 Months Continuous Smoking Abstinence | participants who reported smoking abstinence continuously from 6 months 18 months | measured from 6 months to 18 months |
| Weight | weight in kilograms | Baseline, 6 and 18 months |
| Body Mass Index | Baseline, 18 months |
| Six Minute Walk | 18 months |
| Framingham Stroke Risk Profile Score | The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke | 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 | 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. | Baseline |
| Incarceration |
|
| BG001 | Treatment as Usual | referral to quit line |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Psychiatric Diagnosis | Count of Participants | Participants |
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| Smoking, Willingness to quit | Count of Participants | Participants |
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| Fagerstrom Test for Nicotine Dependence | Total score range of 0-10 (0=minimum to 10=maximum nicotine dependence), higher score is worse | Mean | Standard Deviation | scores on a scale |
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| Secondary | Smoking Abstinence - 3 Months | Participants with 3 month smoking abstinence | Posted | Count of Participants | Participants | from 15 to 18 months |
|
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| Secondary | Smoking Abstinence | 7-day point prevalence, biochemically validated | Posted | Count of Participants | Participants | measured at 6 and 12 months |
|
|
|
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| Secondary | 12 Months Continuous Smoking Abstinence | participants who reported smoking abstinence continuously from 6 months 18 months | Posted | Count of Participants | Participants | measured from 6 months to 18 months |
|
|
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| Secondary | Weight | weight in kilograms | Posted | Mean | 95% Confidence Interval | kilograms | Baseline, 6 and 18 months |
|
|
|
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| Secondary | Body Mass Index | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 18 months |
|
|
|
|
| Secondary | Six Minute Walk | A substantial proportion of the follow-up visits were off-site where the standardized six-minute walk course could not be used. | Posted | Mean | Standard Deviation | feet | 18 months |
|
|
|
| Secondary | Framingham Stroke Risk Profile Score | The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke | Posted | Mean | Standard Deviation | score on a scale | 18 months |
|
|
|
|
| Secondary | 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 | No modeled | Posted | Mean | Standard Deviation | score on a scale | 6 and 18 months |
|
|
|
| Secondary | 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. | Data not collected at follow up due to excessive participant burden and insufficient staff needed to maintain adequate inter-rater reliability at follow-up time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| 2 |
| 97 |
| 31 |
| 97 |
| 0 |
| 97 |
| EG001 | Treatment as Usual | referral to quit line | 2 | 95 | 23 | 95 | 0 | 95 |
| Medical hospitalization | General disorders | Systematic Assessment |
|
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| 12 month |
|
| Odds Ratio (OR) |
| 10.8 |
| 2-Sided |
| 95 |
| 2.4 |
| 48.6 |
| Superiority |
| 18 month |
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| Mean Difference (Net) |
| 1.6 |
| 2-Sided |
| 95 |
| -1.5 |
| 4.7 |
| Superiority |
| physical score-18 month |
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| mental score- baseline |
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| mental score- 6 month |
|
| mental score- 18 month |
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