Trial Outcomes & Findings for Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training (NCT NCT04005794)

Last Updated: 2025-03-10

Results Overview

Social engagement latency is defined as the time taken to select an avatar in the social skills training game. Social engagement latency is measured in milliseconds. We report the difference in SEL at post training from baseline for Sz group only

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Baseline and social VR post-training (after 8 sessions)

Results posted on

2025-03-10

Participant Flow

Schizophrenia patients undergo both Social VR training and Cognitive Training

Participant milestones

Participant milestones
Measure	Social Skills VR (Virtual Reality) Training, Then Cognitive Training 1. social skills VR training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks. 2. Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Cognitive Training, Then VR Social Skills Training 1. Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks. 2. VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Healthy Controls Healthy controls are recruited to yield comparison data. They do not undergo training.
Overall Study STARTED	11	11	28
Overall Study COMPLETED	11	7	28
Overall Study NOT COMPLETED	0	4	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Social Skills VR (Virtual Reality) Training, Then Cognitive Training 1. social skills VR training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks. 2. Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Cognitive Training, Then VR Social Skills Training 1. Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks. 2. VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Healthy Controls Healthy controls are recruited to yield comparison data. They do not undergo training.
Overall Study Lost to Follow-up	0	4	0

Baseline Characteristics

Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Social Skills VR Training, Then Cognitive Training Game n=11 Participants 1. Social skills VR training: Social skills VR game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks. 2. Cognitive Training Game: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks.	Cognitive Training Game, Then Social Skills VR Training n=11 Participants 1. Cognitive Training Game: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks 2. Social skills VR training: Social skills VR game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Healthy Controls n=28 Participants Healthy controls are recruited to yield comparison data. They do not undergo training. They are not interviewed for clinical symptoms	Total n=50 Participants Total of all reporting groups
Age, Continuous	43.74 years STANDARD_DEVIATION 12.58 • n=5 Participants	45.39 years STANDARD_DEVIATION 11.16 • n=7 Participants	33.43 years STANDARD_DEVIATION 15.35 • n=5 Participants	40.50 years STANDARD_DEVIATION 13.14 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	9 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	28 participants n=5 Participants	50 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and social VR post-training (after 8 sessions)

Population: We examined the social engagement for the social VR game condition only. Commercially available cognitive games did not have a social component and therefore, they do not yield SEL data. Healthy CO do not participate in any training so they do not yield SEL data

Outcome measures

Outcome measures
Measure	VR Social Skills Training n=18 Participants VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Cognitive Training Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Healthy Control Healthy controls are recruited to yield comparison data. They do not undergo training.
Change in Social Attention: Social Engagement Latency (SEL)	-195 milliseconds Standard Deviation 5.60	—	—

SECONDARY outcome

Timeframe: Baseline and after 8 sessions of social VR training and after 8 sessions of cognitive training game

Population: Patients with schizophrenia participated in both social skills VR game and the cognitive training game. 22 people started but only 18 completed both training. Healthy control participants were tested once at baseline

Change in social cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A). There are 21 videos shown to participants and are scored as either correct (1) or incorrect (0). A total score is provided and can range from 0 to 21, with higher scores indicating a higher social cognition ability, a better outcome.

Outcome measures

Outcome measures
Measure	VR Social Skills Training n=18 Participants VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Cognitive Training n=18 Participants Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Healthy Control n=28 Participants Healthy controls are recruited to yield comparison data. They do not undergo training.
Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) Baseline	12.68 score on a scale Standard Error 0.98	12.68 score on a scale Standard Error 0.98	18 score on a scale Standard Error 0.43
Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) After Training	13.00 score on a scale Standard Error 1.15	13.16 score on a scale Standard Error 4.88	—

SECONDARY outcome

Timeframe: Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game for the schizophrenia group only. CO do not undergo clinical symptoms interview.

Population: This is a clinical interview to assess psychotic symptoms. Therefore healthy control group is not interviewed.

SANS is a 25-item clinical symptom rating scale. It consists subscales of alogia, affective blunting, avolition-apathy, anhedonia-asociality, and attentional impairment. (Andreasen, 1983). Each item is scored on likert scale of 0 (none) to 5 (severe - worse outcome). Total score is summed (range 0-125) with higher scores being a worse outcome Andreasen NC: Scale for the Assessment of Negative Symptoms (SANS) . Iowa City, University of Iowa, 1983

Outcome measures

Outcome measures
Measure	VR Social Skills Training n=18 Participants VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Cognitive Training n=18 Participants Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Healthy Control Healthy controls are recruited to yield comparison data. They do not undergo training.
Change in Scale for the Assessment of Negative Symptoms (SANS) Baseline SANS score	44.63636364 score on a scale Standard Error 3.145494582	44.63636364 score on a scale Standard Error 3.145494582	—
Change in Scale for the Assessment of Negative Symptoms (SANS) After training SANS score	34.79 score on a scale Standard Error 3.287917761	43.67 score on a scale Standard Error 3.10175999	—

SECONDARY outcome

Timeframe: Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game

Population: Healthy controls are not interviewed for clinical symptoms because they are not diagnosed.

SAPS has 34-items that evaluate hallucinations, delusions, formal thought disorder and bizarre behavior (Andreasen, 1984). Each subscale has a single global score item to rate the overall severity of each symptom domain. Each item is rated for severity from least (0) to most severe (5). Total scores are summed and range from 0-170 with higher scores indicating a worse outcome. Andreasen NC: Scale for the Assessment of Positive Symptoms (SAPS) . Iowa City, University of Iowa, 1984. (NC Andreasen - The British Journal of Psychiatry, 1989)

Outcome measures

Outcome measures
Measure	VR Social Skills Training n=18 Participants VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Cognitive Training n=18 Participants Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Healthy Control Healthy controls are recruited to yield comparison data. They do not undergo training.
Change in Scale for the Assessment of Positive Symptoms (SAPS) Baseline	37.86363636 score on a scale Standard Error 4.145	37.86363636 score on a scale Standard Error 4.145	—
Change in Scale for the Assessment of Positive Symptoms (SAPS) After Training	28.32 score on a scale Standard Error 4.776	31.28 score on a scale Standard Error 4.008	—

SECONDARY outcome

Timeframe: Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game

Social Functioning Scale (SFS; Birchwood, 1990). SFS consists of 79 items (7 subscales). We use the full scale score. Minimum score is 0 (worst social functioning) and maximum score is 135 (best)

Outcome measures

Outcome measures
Measure	VR Social Skills Training n=18 Participants VR social skills training: Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.	Cognitive Training n=18 Participants Cognitive Training: Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games. They complete 8 sessions over 4-5 weeks	Healthy Control n=28 Participants Healthy controls are recruited to yield comparison data. They do not undergo training.
Change in Social Outcome: Social Functioning Scale. Baseline	96.63636364 score on a scale Standard Error 1.848	96.63636364 score on a scale Standard Error 1.848	107.25 score on a scale Standard Error 1.89
Change in Social Outcome: Social Functioning Scale. After training	98.74 score on a scale Standard Error 1.849	97.56 score on a scale Standard Error 1.856	—

Adverse Events

Social VR Skills Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cognitive Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

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. Sohee Park, Professor of Psychology and the principal investigator

Vanderbilt University

Phone: 615 322 3435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place