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),
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
videogame-based physical activity
sedentary videogame
Bupropion
University of California, San Francisco
San Francisco, California, United States
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.
Time frame: 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.
Time frame: Up to 12 weeks
Mean Score on a Self-report Acceptability Question 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.
Time frame: At week 6
Mean Score on a Self-report Acceptability Question 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.
Time frame: At week 12
Mean Number of Cigarettes Smoked by Group 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.
Time frame: At week 6
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Counseling for smoking cessation
Mean Number of Cigarettes Smoked by Group 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.
Time frame: At week 12
Point-prevalent Abstinence (PPA)
Number of participants reporting not using tobacco at week 12
Time frame: At week 12
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.
Time frame: At Baseline (1 day)
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.
Time frame: At week 6
Mean Scores at Week-12 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.
Time frame: At week 12