Mental Illness, Smoking Cessation, Smoking, Tobacco, Tobacco Use Disorder
Conditions
Keywords
Smoking cessation, Serious mental illness
Brief summary
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),
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.
Interventions
BEHAVIORALVideogame-based physical activity
videogame-based physical activity
BEHAVIORALSedentary videogame
sedentary videogame
DRUGBupropion
Bupropion
BEHAVIORALCounseling
Counseling for smoking cessation
Sponsors
University of California, San Francisco
Tobacco Related Disease Research Program
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a pilot, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Videogame Sessions Attended | 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 | 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 | 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 | 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 | 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 | 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) | At week 12 | Number of participants reporting not using tobacco at week 12 |
| Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS) | 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) | 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) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHeather Leutwyler, PhD
University of California, San Francisco
Participant flow
Pre-assignment details
131 potential participants consented, but 23 participants were lost to contact prior to being randomized to any study intervention. These 23 participants are not considered enrolled due to the fact they were never assigned to, nor received, any study intervention. The pre-covid version of the interventions were dropped from the protocol and analyses due to the extensive changes and were amended to include an outdoor park-based intervention implemented after covid.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 24 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 0 / 49 | 0 / 50 | 0 / 4 | 0 / 5 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 | 0 / 4 | 0 / 5 |
Outcome results
None listed