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Completed

NCT Number: NCT03950427

PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness

This is a research study investigating 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),

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Key information

Conditions

Smoking Cessation Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Mental Illness Smoking Smoking, Tobacco Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94143-0610, United States

About this study

The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a game-based Physical activity, counseling for smoking cessation, and a medication (bupropion or NRT) for smoking cessation.

Study participants will receive counseling to quit smoking and a medication to help decrease cravings and withdrawal. Additionally, participants will be randomly selected to participate in either a game-based physical activity group or a game group where the participants sit to play the games.

Participants will be in this study for 12 weeks total. There are 3 assessment visits (2 hours each) at the beginning of the study, 6 weeks after starting, and at the end of the 12 weeks. There will be 8 30- minute counseling sessions during the 12 weeks. The hour-long videogame groups will be held 3 times a week for 12 weeks (36 sessions). Upon completion of the 12-week program, there will be a 1-2 hour group interview. The total time commitment is 48 hours over the course of the 12-week study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A diagnosis of a Serious Mental Illness (SMI)*
  • 18 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.

Exclusion criteria

  • 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)

Treatment and study plan

Videogame-based physical activity

Behavioral

videogame-based physical activity

Sedentary videogame

Behavioral

sedentary videogame

bupropion

Drug

Bupropion

Other names: Wellbutrin, Zyban

Counseling

Behavioral

Counseling for smoking cessation

Primary outcomes

  1. Total Number of Videogame Sessions Attended

    Time frame: Up to 12 weeks

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

  2. Total Minutes of Videogame Sessions Attended

    Time frame: Up to 12 weeks

    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.

  3. Mean Score on a Self-report Acceptability Question at Week 6

    Time frame: At week 6

    Acceptability was assessed through a single question asked of participants "How enjoyable were the games?" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.

  4. Mean Score on a Self-report Acceptability Question at Week 12

    Time frame: At week 12

    Acceptability was assessed through a single question asked of participants "How enjoyable were the games?" with participants' responses on a Likert scale from 1 (Did not like at all) to 5 (Liked very much). The mean and standard deviation of the response to the question will be calculated for a possible total score range of 1 to 5, with higher scores indicating a higher degree of acceptability.

  5. Mean Number of Cigarettes Smoked by Group at Week 6

    Time frame: At week 6

    The investigators will record the number of cigarettes per participant, 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. Mean Number of Cigarettes Smoked by Group at Week 12

    Time frame: At week 12

    The investigators will record the number of cigarettes per participant, 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.

  7. Point-prevalent Abstinence (PPA)

    Time frame: At week 12

    Number of participants reporting not using tobacco at week 12

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

    Time frame: At Baseline (1 day)

    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.

  9. Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)

    Time frame: At week 6

    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.

  10. Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)

    Time frame: At week 12

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Tobacco Related Disease Research Program

Registry information

Acronym: PARQuit

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 15, 2019
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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