Trial Outcomes & Findings for PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness (NCT NCT03950427)

Last Updated: 2026-07-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

108 participants

Primary outcome timeframe

At week 6

Results posted on

2026-07-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	PARQuit - 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.	PARQuit -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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation	CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID The game-based physical activity group, will play active games using the Kinect for Xbox 360 game system using the Kinect sensor. 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.	CLOSED - Videogame-based Physical (VIP) Sedentary Group, Pre-COVID The sedentary videogame group will play games while seated using the Xbox 360 game system using 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.
Baseline STARTED	49	50	4	5
Baseline COMPLETED	49	50	4	5
Baseline NOT COMPLETED	0	0	0	0
Week 6 STARTED	29	30	3	5
Week 6 COMPLETED	29	30	3	5
Week 6 NOT COMPLETED	0	0	0	0
Week 12 STARTED	26	26	3	4
Week 12 COMPLETED	26	26	3	4
Week 12 NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PARQuit Smoking Cessation Intervention for Adults With Serious Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PARQuit: Game-based Physical Activity Group n=49 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=50 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=20 Participants	48 Participants n=20 Participants	96 Participants n=40 Participants
Age, Categorical >=65 years	1 Participants n=20 Participants	2 Participants n=20 Participants	3 Participants n=40 Participants
Age, Continuous	40.7 years STANDARD_DEVIATION 11.2 • n=20 Participants	49.9 years STANDARD_DEVIATION 11.9 • n=20 Participants	45.4 years STANDARD_DEVIATION 12.4 • n=40 Participants
Sex: Female, Male Female	16 Participants n=20 Participants	18 Participants n=20 Participants	34 Participants n=40 Participants
Sex: Female, Male Male	33 Participants n=20 Participants	32 Participants n=20 Participants	65 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=20 Participants	4 Participants n=20 Participants	8 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=20 Participants	46 Participants n=20 Participants	90 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Asian	2 Participants n=20 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	11 Participants n=20 Participants	13 Participants n=20 Participants	24 Participants n=40 Participants
Race (NIH/OMB) White	23 Participants n=20 Participants	22 Participants n=20 Participants	45 Participants n=40 Participants
Race (NIH/OMB) More than one race	13 Participants n=20 Participants	11 Participants n=20 Participants	24 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Region of Enrollment United States	49 participants n=20 Participants	50 participants n=20 Participants	99 participants n=40 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Feasibility will be measured with a total count of sessions attended. The graduate student researcher (GSR) will document participant attendance.

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=49 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=50 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Total Number of Videogame Sessions Attended	12 Sessions attended	10 Sessions attended

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=49 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=50 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Total Minutes of Videogame Sessions Attended	560.9 Minutes	473.7 Minutes

PRIMARY outcome

Timeframe: At week 6

Population: There were a large number of participants who did not complete the acceptability questionnaire 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.

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=10 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=12 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Score on a Self-report Acceptability Question at Week 6	4.7 score on a scale Standard Deviation .67	4.6 score on a scale Standard Deviation .80

PRIMARY outcome

Timeframe: At week 12

Population: There were a large number of participants who did not complete the questionnaire at week 12

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=8 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=12 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Score on a Self-report Acceptability Question at Week 12	4.8 score on a scale Standard Deviation .37	4.8 score on a scale Standard Deviation .58

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=29 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=30 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Number of Cigarettes Smoked by Group at Week 6	38 cigarettes smoked in past week Standard Deviation 38.9	34 cigarettes smoked in past week Standard Deviation 40.1

PRIMARY outcome

Timeframe: At week 12

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=26 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=26 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Number of Cigarettes Smoked by Group at Week 12	27 cigarettes smoked in past week Standard Deviation 22.3	41 cigarettes smoked in past week Standard Deviation 49.7

PRIMARY outcome

Timeframe: At week 12

Number of participants reporting not using tobacco at week 12

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=26 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=26 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Point-prevalent Abstinence (PPA)	6 Participants	5 Participants

PRIMARY outcome

Timeframe: At Baseline (1 day)

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=49 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=50 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Scores at Baseline on the Brief Psychiatric Rating Scale (BPRS)	40.2 scores on a scale Standard Deviation 9.5	43.1 scores on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: At week 6

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=29 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=30 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Scores at Week-6 on the Brief Psychiatric Rating Scale (BPRS)	37.3 scores on a scale Standard Deviation 10.8	37.2 scores on a scale Standard Deviation 10.6

PRIMARY outcome

Timeframe: At week 12

Outcome measures

Outcome measures
Measure	PARQuit: Game-based Physical Activity Group n=26 Participants 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. Videogame-based physical activity: videogame-based physical activity Bupropion: Bupropion Counseling: Counseling for smoking cessation	PARQuit: Sedentary Videogame Group n=26 Participants 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. Sedentary videogame: sedentary videogame Bupropion: Bupropion Counseling: Counseling for smoking cessation
Mean Scores at Week-12 on the Brief Psychiatric Rating Scale (BPRS)	38.2 scores on a scale Standard Deviation 11.8	38.2 scores on a scale Standard Deviation 9.5

Adverse Events

PARQuit: Game-based Physical Activity Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PARQuit: Sedentary Videogame Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CLOSED - Videogame-based Physical (VIP) Active Group, Pre-COVID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CLOSED - Videogame-based Physical (VIP) Sedentary Group, Pre-COVID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Heather Leutwyler, PhD, RN, NP

University of California, San Francisco

Phone: 415-514-1524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place