Clinical trial NCT03950427: PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
Official title: PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Smoking, Tobacco
Mental Illness
Tobacco Use Disorder
Keywords: smoking cessation
serious mental illness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
First posted: 2019-05-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Total number of videogame sessions attended
timeFrame: 12-weeks
measure: Total minutes of videogame sessions attended
timeFrame: 12-weeks
measure: Week-6 Self-report acceptability rankings of the videogames
timeFrame: administered at week 6
measure: Week-12 Self-report acceptability rankings of the videogames -week 12
timeFrame: administered at week 12.
measure: Tobacco reduction and abstinence
timeFrame: administered at week 6.
measure: Tobacco reduction and abstinence
timeFrame: administered at week 12.
measure: Baseline Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline interview with the participant and observations of the participant's behavior over the previous 2-3 days.
measure: Week-6 Brief Psychiatric Rating Scale (BPRS)
timeFrame: interview at week-6 with the participant and observations of the participant's behavior over the previous 2-3 days.
measure: Week-12 Brief Psychiatric Rating Scale (BPRS)
timeFrame: interview at week-12 with the participant and observations of the participant's behavior over the previous 2-3 days.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Heather Leutwyler, PhD
role: PRINCIPAL_INVESTIGATOR
References: