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| ID | Type | Description | Link |
|---|---|---|---|
| 22637 | Other Identifier | University of California, San Francisco | |
| NCI-2022-02281 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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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),
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Videogame-based physical activity | Behavioral | videogame-based physical activity |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Leutwyler, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-0610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42143578 | Derived | Whitmore H, Hubbard E, Cooper B, Leutwyler H. Randomized Controlled Trial of a Group-Based Smoking Cessation Intervention for Adults With Serious Mental Illness. Nicotine Tob Res. 2026 May 17:ntag110. doi: 10.1093/ntr/ntag110. Online ahead of print. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 19, 2026 | 8 | ||
| May 21, 2026 |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| D001523 | Mental Disorders |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D019966 |
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| ID | Term |
|---|---|
| D016642 | Bupropion |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D008605 | Mental Health Services |
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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.
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| Sedentary videogame | Behavioral | sedentary videogame |
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| Bupropion | Drug | Bupropion |
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| Counseling | Behavioral | Counseling for smoking cessation |
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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 |
| Jun 17, 2026 |
| 9 |
| Jun 17, 2026 | Jun 18, 2026 | 10 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D004191 |
| Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |