Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Heather Leutwyler, PhD
Headshot of Heather Leutwyler
Heather Leutwyler

Description

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),

Details

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.

Keywords

Smoking Cessation, Smoking, Tobacco, Mental Illness, Tobacco Use Disorder, serious mental illness, Mental Disorders, Bupropion, Videogame-based physical activity, sedentary videogame

Eligibility

You can join if…

Open to people ages 18 years and up

  • A diagnosis of a 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.

You CAN'T join 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)

Location

  • UCSF accepting new patients
    San Francisco California 94143-0610 United States

Lead Scientist at UCSF

  • Heather Leutwyler, PhD
    My program of research focuses on the identification of factors associated with poor physical health among older adults with schizophrenia in order to design effective interventions.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03950427
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated