Back to resultsPARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness (PARQuit)
Primary Purpose
Smoking Cessation, Smoking, Tobacco, Mental Illness
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Videogame-based physical activity
sedentary videogame
Bupropion
Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring smoking cessation, serious mental illness
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
game-based Physical Activity Group
Sedentary Videogame Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Week-12 Self-report acceptability rankings of the videogames -week 12
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.
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.
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.
Baseline 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Week-6 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Week-12 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Secondary Outcome Measures
Full Information
NCT ID
NCT03950427
First Posted
May 13, 2019
Last Updated
September 15, 2023
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
1. Study Identification
Unique Protocol Identification Number
NCT03950427
Brief Title
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
Acronym
PARQuit
Official Title
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Smoking, Tobacco, Mental Illness, Tobacco Use Disorder
Keywords
smoking cessation, serious mental illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
game-based Physical Activity Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sedentary Videogame Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Videogame-based physical activity
Intervention Description
videogame-based physical activity
Intervention Type
Behavioral
Intervention Name(s)
sedentary videogame
Intervention Description
sedentary videogame
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Wellbutrin, Zyban
Intervention Description
Bupropion
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Counseling for smoking cessation
Primary Outcome Measure Information:
Title
Total number of videogame sessions attended
Description
Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.
Time Frame
12-weeks
Title
Total minutes of videogame sessions attended
Description
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
12-weeks
Title
Week-6 Self-report acceptability rankings of the videogames
Description
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.
Time Frame
administered at week 6
Title
Week-12 Self-report acceptability rankings of the videogames -week 12
Description
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.
Time Frame
administered at week 12.
Title
Tobacco reduction and abstinence
Description
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.
Time Frame
administered at week 6.
Title
Tobacco reduction and abstinence
Description
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.
Time Frame
administered at week 12.
Title
Baseline Brief Psychiatric Rating Scale (BPRS)
Description
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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Time Frame
Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days.
Title
Week-6 Brief Psychiatric Rating Scale (BPRS)
Description
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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Time Frame
interview at week-6 with the participant and observations of the participant's behavior over the previous 2-3 days.
Title
Week-12 Brief Psychiatric Rating Scale (BPRS)
Description
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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Time Frame
interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Leutwyler, PhD
Phone
415-514-1524
Email
heather.leutwyler@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Hubbard, MPH
Phone
415-502-7774
Email
erin.hubbard@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Leutwyler, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Leutwyler, PhD
Phone
415-514-1524
Email
Heather.Leutwyler@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
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