Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH (TRIUMPH)
Primary Purpose
Mental Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TRIIUMPH Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Mental Illness focused on measuring weight management, physical activity, Tobacco smoking, Serious mental illness
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TRIUMPH intervention
Treatment as Usual
Arm 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
referral to quit line
Outcomes
Primary Outcome Measures
smoking abstinence
7-day point prevalence, biochemically validated
Secondary Outcome Measures
smoking abstinence - 3 months
3 month smoking abstinence
smoking abstinence
7-day point prevalence, biochemically validated
continuous smoking abstinence - 12 months
12 month smoking abstinence
Weight
weight in pounds
Body Mass Index
Six Minute Walk
Framingham Risk Score
global Framingham Risk Score
Health Status
measured by SF-12
Psychiatric Symptoms
Brief Psychiatric Rating Scale
Full Information
NCT ID
NCT02424188
First Posted
April 18, 2015
Last Updated
September 29, 2023
Sponsor
Johns Hopkins University
Collaborators
Massachusetts General Hospital, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02424188
Brief Title
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Acronym
TRIUMPH
Official Title
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Massachusetts General Hospital, National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
weight management, physical activity, Tobacco smoking, Serious mental illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRIUMPH intervention
Arm Type
Experimental
Arm 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
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
referral to quit line
Intervention Type
Other
Intervention Name(s)
TRIIUMPH Intervention
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
Primary Outcome Measure Information:
Title
smoking abstinence
Description
7-day point prevalence, biochemically validated
Time Frame
measured at 18 months
Secondary Outcome Measure Information:
Title
smoking abstinence - 3 months
Description
3 month smoking abstinence
Time Frame
from 15 to 18 months
Title
smoking abstinence
Description
7-day point prevalence, biochemically validated
Time Frame
measured at 6 and 12 months
Title
continuous smoking abstinence - 12 months
Description
12 month smoking abstinence
Time Frame
measured at 18 months
Title
Weight
Description
weight in pounds
Time Frame
6 and 18 months
Title
Body Mass Index
Time Frame
6 and 18 months
Title
Six Minute Walk
Time Frame
6 and 18 months
Title
Framingham Risk Score
Description
global Framingham Risk Score
Time Frame
18 months
Title
Health Status
Description
measured by SF-12
Time Frame
6 and 18 months
Title
Psychiatric Symptoms
Description
Brief Psychiatric Rating Scale
Time Frame
6 and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L Daumit, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. Eden Evins, MD, MPH
Organizational Affiliation
Massachussetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
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