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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

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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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