Condition or disease | Intervention/treatment | Phase |
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Smoking Cessation Smoking, Tobacco Mental Illness Tobacco Use Disorder | Behavioral: Videogame-based physical activity Behavioral: sedentary videogame Drug: Bupropion Behavioral: Counseling | Phase 4 |
The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a Videogame-based Physical activity, counseling for smoking cessation, and a medication (bupropion) 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 videogame-based physical activity group or a videogame 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | a pilot 2-arm 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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | VIP Smoking Cessation Intervention for Adults With Serious Mental Illness |
Actual Study Start Date : | July 8, 2019 |
Estimated Primary Completion Date : | July 1, 2021 |
Estimated Study Completion Date : | July 1, 2021 |
Arm | Intervention/treatment |
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Active Comparator: Videogame-based Physical Activity Group
The videogame-based physical activity group, will play active videogames using the Kinect for Xbox 360 game system. Each videogame 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
videogame-based physical activity
Drug: Bupropion Bupropion
Other Names:
Behavioral: Counseling Counseling for smoking cessation
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Placebo Comparator: Sedentary Videogame Group
The sedentary videogame group will play videogames while seated using the Xbox 360 game system (without the Kinect sensor). 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
sedentary videogame
Drug: Bupropion Bupropion
Other Names:
Behavioral: Counseling Counseling for smoking cessation
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Capacity to consent.
Exclusion Criteria:
Contact: Heather Leutwyler, PhD | 415-514-1524 | heather.leutwyler@ucsf.edu | |
Contact: Erin Hubbard, MPH | 415-502-7774 | erin.hubbard@ucsf.edu |
United States, California | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143-0610 | |
Contact: Heather Leutwyler, PhD 415-514-1524 Heather.Leutwyler@ucsf.edu |
Principal Investigator: | Heather Leutwyler, PhD | University of California, San Francisco |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 13, 2019 | ||||||||
First Posted Date ICMJE | May 15, 2019 | ||||||||
Last Update Posted Date | August 5, 2020 | ||||||||
Actual Study Start Date ICMJE | July 8, 2019 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | VIP Smoking Cessation Intervention for Adults With Serious Mental Illness | ||||||||
Official Title ICMJE | VIP Smoking Cessation Intervention for Adults With Serious Mental Illness | ||||||||
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), | ||||||||
Detailed Description |
The purpose of this study is to learn more about how adults with serious mental illness respond to a smoking cessation program combining a Videogame-based Physical activity, counseling for smoking cessation, and a medication (bupropion) 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 videogame-based physical activity group or a videogame 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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 4 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: a pilot 2-arm 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. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
60 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 1, 2021 | ||||||||
Estimated Primary Completion Date | July 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03950427 | ||||||||
Other Study ID Numbers ICMJE | T29IP0235 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of California, San Francisco | ||||||||
Study Sponsor ICMJE | University of California, San Francisco | ||||||||
Collaborators ICMJE | Tobacco Related Disease Research Program | ||||||||
Investigators ICMJE |
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PRS Account | University of California, San Francisco | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |