Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

Mental Illness Clinical Trial

— TRIUMPH  

Official title:

Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424188
• Other study ID #: IRB00072510
• Secondary ID: R01MH104553
• Status: Completed
• Phase: N/A
• Start date: July 7, 2016
• Est. completion date: March 2020

Study information

• Verified date: September 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Massachusetts General Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking abstinence	7-day point prevalence, biochemically validated	measured at 18 months
Secondary	smoking abstinence - 3 months	3 month smoking abstinence	from 15 to 18 months
Secondary	smoking abstinence	7-day point prevalence, biochemically validated	measured at 6 and 12 months
Secondary	continuous smoking abstinence - 12 months	12 month smoking abstinence	measured at 18 months
Secondary	Weight	weight in pounds	6 and 18 months
Secondary	Body Mass Index		6 and 18 months
Secondary	Six Minute Walk		6 and 18 months
Secondary	Framingham Risk Score	global Framingham Risk Score	18 months
Secondary	Health Status	measured by SF-12	6 and 18 months
Secondary	Psychiatric Symptoms	Brief Psychiatric Rating Scale	6 and 18 months