PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Total number of videogame sessions attended
研究概览
简要总结
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),
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Game-based Physical Activity Group
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.
干预措施: Bupropion (Drug)
Sedentary Videogame Group
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.
干预措施: Bupropion (Drug)
Game-based Physical Activity Group
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.
干预措施: Counseling (Behavioral)
Game-based Physical Activity Group
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.
干预措施: Videogame-based physical activity (Behavioral)
Sedentary Videogame Group
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.
干预措施: Sedentary videogame (Behavioral)
Sedentary Videogame Group
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.
干预措施: Counseling (Behavioral)
结局指标
主要结局
Total number of videogame sessions attended
时间窗: Up to 12 weeks
Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.
Week-6 Self-report acceptability rankings of the videogames
时间窗: 6 weeks
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.
Week-12 Self-report acceptability rankings of the videogames
时间窗: 12 weeks
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.
Total minutes of videogame sessions attended
时间窗: 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.
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)
时间窗: Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days.
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.
Mean scores at Week-612 on the Brief Psychiatric Rating Scale (BPRS)
时间窗: 12 weeks
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.
Week-6 Tobacco reduction and abstinence
时间窗: 6 weeks
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.
Week-12 Tobacco reduction and abstinence
时间窗: 12 weeks
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.
Mean scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)
时间窗: 6 weeks
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.
Total Number of Videogame Sessions Attended
时间窗: Up to 12 weeks
Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.
Total Minutes of Videogame Sessions Attended
时间窗: 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.
Mean Score on a Self-report Acceptability Question at Week 6
时间窗: 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.
Mean Score on a Self-report Acceptability Question at Week 12
时间窗: 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.
Mean Number of Cigarettes Smoked by Group at Week 6
时间窗: 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.
Mean Number of Cigarettes Smoked by Group at Week 12
时间窗: 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.
Point-prevalent Abstinence (PPA)
时间窗: At week 12
Number of participants reporting not using tobacco at week 12
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)
时间窗: 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.
Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)
时间窗: 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.
Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)
时间窗: 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.
次要结局
未报告次要终点