PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness

NCT03950427 | Completed Phase 4 FDA Drug

• 3 other identifiers: T29IP023522637NCI-2022-02281
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study about a smoking cessation program tailored for adults with serious mental illness (SMI). The program uses a Videogame-based Physical (VIP) activity, smoking cessation counseling, and medication (bupropion),

Conditions

Smoking Cessation; Smoking, Tobacco; Mental Illness; Tobacco Use Disorder

Keywords

smoking cessation; serious mental illness

Outcome Measures

Primary Outcomes (9)

• Total number of videogame sessions attended

  Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.

  Up to 12 weeks

• Total minutes of videogame sessions attended

  Feasibility will be measured with a sum of minutes attended. The GSR will monitor and document the times when participants enter and leave the sessions.

  Up to 12 weeks

• Week-6 Self-report acceptability rankings of the videogames

  This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis.

  6 weeks

• Week-12 Self-report acceptability rankings of the videogames

  This internally developed acceptability questionnaire has 7 questions. Three questions use a 1 to 5 scale with 1 indicating least acceptable and 5 indicating most acceptable, for a possible total range of 3-15. The remaining open-ended questions are scored using qualitative thematic analysis. Used to measure change from week-6 to week-12.

  12 weeks

• Week-6 Tobacco reduction and abstinence

  The investigators will ask about the number of cigarettes, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.

  6 weeks

• Week-12 Tobacco reduction and abstinence

  The investigators will ask about the number of cigarettes, even a puff, smoked in the past week (7-day abstinence) or use of any form of tobacco or alternative tobacco product e.g., e-cigarette or heat not burn. Salivary cotinine levels will be measured to determine abstinence from smoking.

  12 weeks

• Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)

  The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.

  Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days.

• Mean scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)

  The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.

  6 weeks

• Mean scores at Week-612 on the Brief Psychiatric Rating Scale (BPRS)

  The Semi-Structured Interview for Brief Psychiatric Rating Scale is completed by the PI or trained research staff and assesses the number and severity of psychiatric symptoms. It consists of 24 items that are rated from 1 (not present) to 7 (extremely severe), and the items are summed for a total psychopathology score, with a possible range from 24-168 and a higher score indicating a higher severity of illness.

  12 weeks

Study Arms (2)

Game-based Physical Activity Group

ACTIVE COMPARATOR

The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system or outdoors in a public park. Each game group will be facilitated by the study coordinator, the principal investigator or other study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.

Behavioral: Videogame-based physical activity; Drug: Bupropion; Behavioral: Counseling

Sedentary Videogame Group

PLACEBO COMPARATOR

The sedentary videogame group will play games while seated using the Xbox 360 game system (without the Kinect sensor) or seated outdoors in a public park. Each sedentary videogame group will be facilitated by study staff. Participants in this group will also receive bupropion and counseling for smoking cessation.

Behavioral: Sedentary videogame; Drug: Bupropion; Behavioral: Counseling

Interventions

Videogame-based physical activity BEHAVIORAL

videogame-based physical activity

Game-based Physical Activity Group

Sedentary videogame BEHAVIORAL

sedentary videogame

Sedentary Videogame Group

Bupropion DRUG

Bupropion

Also known as: Wellbutrin, Zyban

Game-based Physical Activity Group; Sedentary Videogame Group

Counseling BEHAVIORAL

Counseling for smoking cessation

Game-based Physical Activity Group; Sedentary Videogame Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of a Serious Mental Illness (SMI)\*
• years and older
• Smoking at least five cigarettes per day for the past 6 months
• Willingness to set a quit date
• Not currently taking bupropion or using nicotine replacement therapy (NRT)
• Current participant in the residential or day treatment program at a Progress Foundation program with the intention to continue in the residential or day treatment program for at least the 12 week intervention period
• Capacity to consent.
• SMI is characterized by the American Psychological Association as distinct conditions that require routine management, produce functional impairment, and interfere with quality of life. Individuals that typically meet the criteria of SMI have illnesses that include schizophrenia, schizoaffective disorder, psychotic disorders, major depressive disorders, bipolar disorders, and borderline personality disorder.

You may not qualify if:

• Currently pregnant or breastfeeding
• Diagnosis of seizure disorder, history of anorexia/bulimia, undergoing abrupt discontinuation of ethanol or sedatives, other conditions that increase seizure risk (e.g., arteriovenous malformation (AVM), severe head injury, central nervous system (CNS) tumor)
• use of Monoamine oxidase (MAO) inhibitors (concurrently or within 14 days of discontinuing either bupropion or the MAO inhibitor)
• Planning to become pregnant during the study period
• Previous participation in the videogame-based physical activity intervention.
• Known medical conditions or other physical problems that need special attention in an exercise program (e.g. prior myocardial infarction, uncontrolled hypertension, history of angioplasty, history of angina, use of nitroglycerin to treat angina)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0610, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking; Mental Disorders; Tobacco Use Disorder

Interventions

Bupropion; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Heather Leutwyler, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a pilot, randomized controlled trial (RCT) to examine the feasibility and potential efficacy of an application of a videogame-based group physical activity intervention for smoking cessation in adults with SMI.

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: July 8, 2019
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)