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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02424188
• Collaborator: Massachusetts General Hospital (Other)
• Enrollment: 192
• Location: 1
• Arms: 2
• Actual Duration (Months): 43.8
• Patients Per Site Per Month: 4.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Illness	Other: TRIIUMPH Intervention	N/A

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

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Trial of Integrated Smoking Cessation, Exercise and Weight Management in Serious Mental Illness: TRIUMPH
• Actual Study Start Date: Jul 7, 2016
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
No Intervention: Treatment as Usual referral to quit line

Outcome Measures

Primary Outcome Measures

1. smoking abstinence [measured at 18 months]

   7-day point prevalence, biochemically validated

Secondary Outcome Measures

1. smoking abstinence - 3 months [from 15 to 18 months]

   3 month smoking abstinence

2. smoking abstinence [measured at 6 and 12 months]

   7-day point prevalence, biochemically validated

3. continuous smoking abstinence - 12 months [measured at 18 months]

   12 month smoking abstinence

4. Weight [6 and 18 months]

   weight in pounds

5. Body Mass Index [6 and 18 months]

6. Six Minute Walk [6 and 18 months]

7. Framingham Risk Score [18 months]

   global Framingham Risk Score

8. Health Status [6 and 18 months]

   measured by SF-12

9. Psychiatric Symptoms [6 and 18 months]

   Brief Psychiatric Rating Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Massachusetts General Hospital

Investigators

• Principal Investigator: Gail L Daumit, MD, MHS, Johns Hopkins University
• Principal Investigator: A. Eden Evins, MD, MPH, Massachussetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02424188
• Other Study ID Numbers: IRB00072510; MH104553
• First Posted: Apr 22, 2015
• Last Update Posted: May 13, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Johns Hopkins University: weight management; physical activity; Tobacco smoking; Serious mental illness
• Additional relevant MeSH terms: Mental Disorders

Study Results

No Results Posted as of May 13, 2020