Mental Illness
Conditions
Keywords
weight management, physical activity, Tobacco smoking, Serious mental illness
Brief 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.
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.
Interventions
OTHERTRIIUMPH 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
Sponsors
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Smoking Abstinence | measured at 18 months | 7-day point prevalence, biochemically validated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | measured at 6 and 12 months | 7-day point prevalence, biochemically validated |
| 12 Months Continuous Smoking Abstinence | measured from 6 months to 18 months | participants who reported smoking abstinence continuously from 6 months 18 months |
| Weight | Baseline, 6 and 18 months | weight in kilograms |
| Body Mass Index | Baseline, 18 months | — |
| Smoking Abstinence - 3 Months | from 15 to 18 months | Participants with 3 month smoking abstinence |
| Framingham Stroke Risk Profile Score | 18 months | The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke |
| Health Status as Assessed by the Short Form -12 (SF-12) Index | 6 and 18 months | SF-12 Mental Health Index and Physical Composite (scores range from 0-100), the higher the score means a better outcome |
| Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale | Baseline | 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. |
| Six Minute Walk | 18 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 97 |
| Treatment as Usual referral to quit line | 95 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Incarceration | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Treatment as Usual | TRIUMPH Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 86 Participants | 89 Participants | 175 Participants |
| Age, Continuous | 51.3 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 12.1 | 49.6 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants | 93 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Fagerstrom Test for Nicotine Dependence | 4.6 scores on a scale STANDARD_DEVIATION 2 | 4.5 scores on a scale STANDARD_DEVIATION 2 | 4.5 scores on a scale STANDARD_DEVIATION 2 |
| Primary Psychiatric Diagnosis Bipolar disorder | 33 Participants | 29 Participants | 62 Participants |
| Primary Psychiatric Diagnosis Major depressive disorder | 22 Participants | 26 Participants | 48 Participants |
| Primary Psychiatric Diagnosis Schizoaffective disorder | 25 Participants | 30 Participants | 55 Participants |
| Primary Psychiatric Diagnosis Schizophrenia | 15 Participants | 12 Participants | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 46 Participants | 47 Participants | 93 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 45 Participants | 45 Participants | 90 Participants |
| Region of Enrollment United States | 95 Participants | 97 Participants | 192 Participants |
| Sex: Female, Male Female | 52 Participants | 45 Participants | 97 Participants |
| Sex: Female, Male Male | 43 Participants | 52 Participants | 95 Participants |
| Smoking, Willingness to quit Quit in 2 months | 58 Participants | 61 Participants | 119 Participants |
| Smoking, Willingness to quit Quit in 6 months | 37 Participants | 36 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 97 | 2 / 95 |
| other Total, other adverse events | 0 / 97 | 0 / 95 |
| serious Total, serious adverse events | 31 / 97 | 23 / 95 |
Outcome results
Primary
Number of Participants With Smoking Abstinence
7-day point prevalence, biochemically validated
Time frame: measured at 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH Intervention | Number of Participants With Smoking Abstinence | 27 Participants |
| Treatment as Usual | Number of Participants With Smoking Abstinence | 6 Participants |
95% CI: [2.3, 15.4]
Secondary
12 Months Continuous Smoking Abstinence
participants who reported smoking abstinence continuously from 6 months 18 months
Time frame: measured from 6 months to 18 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TRIUMPH Intervention | 12 Months Continuous Smoking Abstinence | Abstinent | 6 Participants |
| TRIUMPH Intervention | 12 Months Continuous Smoking Abstinence | Not abstinent | 91 Participants |
| Treatment as Usual | 12 Months Continuous Smoking Abstinence | Abstinent | 0 Participants |
| Treatment as Usual | 12 Months Continuous Smoking Abstinence | Not abstinent | 95 Participants |
Secondary
Body Mass Index
Time frame: Baseline, 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRIUMPH Intervention | Body Mass Index | Baseline | 32.1 kg/m^2 | Standard Deviation 8.2 |
| TRIUMPH Intervention | Body Mass Index | 18 months | 32.3 kg/m^2 | Standard Deviation 8.9 |
| Treatment as Usual | Body Mass Index | Baseline | 32 kg/m^2 | Standard Deviation 7 |
| Treatment as Usual | Body Mass Index | 18 months | 31.3 kg/m^2 | Standard Deviation 7.3 |
95% CI: [-0.6, 1.5]
Secondary
Framingham Stroke Risk Profile Score
The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Time frame: 18 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRIUMPH Intervention | Framingham Stroke Risk Profile Score | Baseline | 9.5 score on a scale | Standard Deviation 2.6 |
| TRIUMPH Intervention | Framingham Stroke Risk Profile Score | 18 months | 9.3 score on a scale | Standard Deviation 2.7 |
| Treatment as Usual | Framingham Stroke Risk Profile Score | Baseline | 11.1 score on a scale | Standard Deviation 2.9 |
| Treatment as Usual | Framingham Stroke Risk Profile Score | 18 months | 11.6 score on a scale | Standard Deviation 2.7 |
95% CI: [-30.2, -2.3]
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
Time frame: 6 and 18 months
Population: No modeled
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-baseline | 45.0 score on a scale | Standard Deviation 10.6 |
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-6 month | 45.5 score on a scale | Standard Deviation 8.6 |
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-18 month | 45.8 score on a scale | Standard Deviation 9.2 |
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- baseline | 46.8 score on a scale | Standard Deviation 7.6 |
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- 6 month | 48.3 score on a scale | Standard Deviation 9.2 |
| TRIUMPH Intervention | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- 18 month | 48.3 score on a scale | Standard Deviation 7.9 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- 6 month | 46.2 score on a scale | Standard Deviation 10.3 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-baseline | 43.2 score on a scale | Standard Deviation 10.3 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- baseline | 45.5 score on a scale | Standard Deviation 9.6 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-6 month | 42.5 score on a scale | Standard Deviation 10.5 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | mental score- 18 month | 48.0 score on a scale | Standard Deviation 8.6 |
| Treatment as Usual | Health Status as Assessed by the Short Form -12 (SF-12) Index | physical score-18 month | 43.1 score on a scale | Standard Deviation 8.2 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TRIUMPH Intervention | Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale | 42.0 score on a scale | Standard Deviation 12.5 |
| Treatment as Usual | Psychiatric Symptoms Assessed by the Brief Psychiatric Rating Scale | 41.0 score on a scale | Standard Deviation 10.7 |
Secondary
Six Minute Walk
Time frame: 18 months
Population: A substantial proportion of the follow-up visits were off-site where the standardized six-minute walk course could not be used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TRIUMPH Intervention | Six Minute Walk | Baseline | 1000.7 feet | Standard Deviation 403.1 |
| TRIUMPH Intervention | Six Minute Walk | 18 month | 953.6 feet | Standard Deviation 208.2 |
| Treatment as Usual | Six Minute Walk | Baseline | 943.8 feet | Standard Deviation 321.5 |
| Treatment as Usual | Six Minute Walk | 18 month | 942.4 feet | Standard Deviation 384.1 |
Secondary
Smoking Abstinence
7-day point prevalence, biochemically validated
Time frame: measured at 6 and 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| TRIUMPH Intervention | Smoking Abstinence | 6 month | abstinent | 13 Participants |
| TRIUMPH Intervention | Smoking Abstinence | 6 month | not abstinent | 84 Participants |
| TRIUMPH Intervention | Smoking Abstinence | 12 month | abstinent | 18 Participants |
| TRIUMPH Intervention | Smoking Abstinence | 12 month | not abstinent | 79 Participants |
| Treatment as Usual | Smoking Abstinence | 12 month | not abstinent | 93 Participants |
| Treatment as Usual | Smoking Abstinence | 6 month | abstinent | 3 Participants |
| Treatment as Usual | Smoking Abstinence | 12 month | abstinent | 2 Participants |
| Treatment as Usual | Smoking Abstinence | 6 month | not abstinent | 92 Participants |
Comparison: 6 month comparison95% CI: [1.3, 17.5]
Comparison: 12 month95% CI: [2.4, 48.6]
Secondary
Smoking Abstinence - 3 Months
Participants with 3 month smoking abstinence
Time frame: from 15 to 18 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TRIUMPH Intervention | Smoking Abstinence - 3 Months | 14 Participants |
| Treatment as Usual | Smoking Abstinence - 3 Months | 4 Participants |
95% CI: [1.2, 12.3]
Secondary
Weight
weight in kilograms
Time frame: Baseline, 6 and 18 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| TRIUMPH Intervention | Weight | Baseline | 92.1 kilograms |
| TRIUMPH Intervention | Weight | 6 month | 92.2 kilograms |
| TRIUMPH Intervention | Weight | 18 month | 92.2 kilograms |
| Treatment as Usual | Weight | Baseline | 89.8 kilograms |
| Treatment as Usual | Weight | 6 month | 89.6 kilograms |
| Treatment as Usual | Weight | 18 month | 88.4 kilograms |
Comparison: 6 months95% CI: [-1.7, 2.3]
Comparison: 18 months95% CI: [-1.5, 4.7]