4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / VIP Smoking Cessation Intervention for Adults With Serious Mental Illness (VIP)

VIP Smoking Cessation Intervention for Adults With Serious Mental Illness (VIP)

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),

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking, Tobacco Mental Illness Tobacco Use Disorder Behavioral: Videogame-based physical activity Behavioral: sedentary videogame Drug: Bupropion Behavioral: Counseling Phase 4

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.

Study Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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:
  • Wellbutrin
  • Zyban

Behavioral: Counseling
Counseling for smoking cessation

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:
  • Wellbutrin
  • Zyban

Behavioral: Counseling
Counseling for smoking cessation

Outcome Measures
Primary Outcome Measures :
  1. Total number of videogame sessions attended [ Time Frame: 12-weeks ]
    Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.

  2. Total minutes of videogame sessions attended [ Time Frame: 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.

  3. Week-6 Self-report acceptability rankings of the videogames [ Time Frame: administered at week 6 ]
    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.

  4. Week-12 Self-report acceptability rankings of the videogames -week 12 [ Time Frame: administered at 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.

  5. Tobacco reduction and abstinence [ Time Frame: administered at week 6. ]
    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. Tobacco reduction and abstinence [ Time Frame: administered at week 12. ]
    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.

  7. Baseline Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.

  8. Week-6 Brief Psychiatric Rating Scale (BPRS) [ Time Frame: interview at week-6 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.

  9. Week-12 Brief Psychiatric Rating Scale (BPRS) [ Time Frame: interview at week-12 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Heather Leutwyler, PhD 415-514-1524 heather.leutwyler@ucsf.edu
Contact: Erin Hubbard, MPH 415-502-7774 erin.hubbard@ucsf.edu

Locations
Layout table for location information
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   
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
Investigators
Layout table for investigator information
Principal Investigator: Heather Leutwyler, PhD University of California, San Francisco
Tracking Information
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
 (submitted: August 3, 2020)
  • Total number of videogame sessions attended [ Time Frame: 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 [ Time Frame: 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.
  • Week-6 Self-report acceptability rankings of the videogames [ Time Frame: administered at week 6 ]
    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 [ Time Frame: administered at 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 [ Time Frame: administered at week 6. ]
    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 [ Time Frame: administered at week 12. ]
    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) [ Time Frame: 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. 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) [ Time Frame: interview at week-6 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. 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) [ Time Frame: interview at week-12 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. The score will be used to measure change between the baseline, 6-week, and 12-week time points.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Total number of videogame sessions attended [ Time Frame: 12-weeks ]
    Feasibility will be measured with a total count of sessions attended. The GSR will document participant attendance.
  • Total minutes of videogame sessions attended [ Time Frame: 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.
  • Week-6 Self-report acceptability rankings of the videogames [ Time Frame: administered at week 6 ]
    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 [ Time Frame: administered at 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 [ Time Frame: administered at week 6. ]
    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 [ Time Frame: administered at week 12. ]
    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) [ Time Frame: 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. 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) [ Time Frame: interview at week-6 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. 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) [ Time Frame: interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days. ]
    TThe 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.
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.

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
Condition  ICMJE
  • Smoking Cessation
  • Smoking, Tobacco
  • Mental Illness
  • Tobacco Use Disorder
Intervention  ICMJE
  • Behavioral: Videogame-based physical activity
    videogame-based physical activity
  • Behavioral: sedentary videogame
    sedentary videogame
  • Drug: Bupropion
    Bupropion
    Other Names:
    • Wellbutrin
    • Zyban
  • Behavioral: Counseling
    Counseling for smoking cessation
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: Videogame-based physical activity
    • Drug: Bupropion
    • Behavioral: Counseling
  • 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.

    Interventions:
    • Behavioral: sedentary videogame
    • Drug: Bupropion
    • Behavioral: Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Heather Leutwyler, PhD 415-514-1524 heather.leutwyler@ucsf.edu
Contact: Erin Hubbard, MPH 415-502-7774 erin.hubbard@ucsf.edu
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Tobacco Related Disease Research Program
Investigators  ICMJE
Principal Investigator: Heather Leutwyler, PhD University of California, San Francisco
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