Schizo Affective Disorder, Schizophrenia, Social Skills
Conditions
Keywords
schizophrenia, social skills training, social brain network, virtual reality, simulation, functional outcome
Brief summary
Social impairments are core features of schizophrenia that lead to poor outcome. Social skills and competence improve quality of life and protect against stress-related exacerbation of symptoms, while supporting resilience, interpersonal interactions, and social affiliation. To improve outcome, it is necessary to remediate social deficits. Existing psychosocial interventions are moderately effective but the effort-intensive nature (high burden), low adherence, and weak transfer of skills to everyday life present significant hurdles toward recovery. Thus, there is a dire need to develop effective, engaging and low-burden social interventions for people with schizophrenia that will result in better compliance rates and functional outcome. In a previous pilot study, the investigators tested the effectiveness of a novel adaptive virtual reality (VR) intervention in improving targeted social cognitive function (social attention, as indexed by eye scanning patterns) in individuals with schizophrenia. 10 sessions of 1-hour VR intervention were sufficient to engage the target mechanism of social attention and improve negative symptoms. Acceptability and compliance were very high among the participants. In fact, improvements were seen at about 4-5 sessions. Therefore, we used 8 sessions for the R33 phase. The next phase, supported by a R33 grant compares the VR social skills training with a control condition. This new protocol includes a control condition for the exposure to computerized training across the 8 sessions and incidental exposure to social interactions (i.e. interactions with experimenters twice a week for 4-5 weeks). The control condition consists of commercially available cognitive video games played on the same computer for the same duration as the social VR training condition. This control condition is called Cognitive training game condition.
Detailed description
The effectiveness of the social skills VR training at an optimal dose will be compared with an active control condition (computerized cognitive training game) in improving social attention (Social Engagement Latency: SEL), symptoms and social cogitive functioning in a pilot randomized cross-over trial. Participants with schizophrenia will undergo a baseline assessment of social cognitive functioning, and clinical symptoms. Potential changes after Social skills VR training compared with cognitive game training will be examined. Individuals with schizophrenia will be randomized to either the social skills VR training or the cognitive training at baseline. They will then participate in 8 sessions of social skills VR training or cognitive training (1 hour per session, twice a week for 4-5 weeks). After completion of the 8 sessions per training condition, they will cross over and participate in the other condition. Social engagement latency (SEL) will be used as a measure of social attention which is the primary target. The Social Functional Scale (Birchwood, 1991), the the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS) will be used to assess social functioning and symptoms. Emotion perception will be assesed by the Bell-Lysaker Emotion Recognition Task (BLERT-A). Matched healthy control participants will be recruited to obtain comparison data for optimal performance levels but these healthy control participants will not undergo social skills training. Lastly, at the end of the R33 project, if this VR social skills VR training shows that it can improve social attention, which may improve social outcome in schizophrenia, it will be possible to refine the protocol to make the method more accessible, less burdensome and widely available in the future by moving towards a mobile application.
Interventions
BEHAVIORALsocial VR (virtual reality) 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.
BEHAVIORALCognitive training (control 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.
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blind to the training condition. Schizophrenia participants know which games they are playing so although we do not tell them whether they are being trained for social skills or not, it is not possible to make sure that they are unaware of the types of games that they are asked to play
Intervention model description
Two conditions are compared in individuals with schizophrenia in a cross over design: social skills Virtual Reality (VR) training and active control condition of cognitive training game (non-social, cognitive video game). Participants are assigned at random to either start with social VR (Virtual Reality) skills training and cross over to the cognitive game at baseline, or start with the cognitive game and cross over to the social VR (Virtual Reality) training. They are assessed at baseline for symptoms, social function, emotion perception. They participate in the assigned condition until completion. They then get post-training assessments after which they switch over to the other condition. This cross-over design was implemented due to the closure of the laboratory during the pandemic. Healthy controls are run on the baseline tasks to provide the comparison data for the patient groups but the controls do not undergo VR training nor they yield any clinical symptoms data.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion and
Exclusion criteria
for Individuals with Schizophrenia: Inclusion criteria for schizophrenia group: * Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Axis 1 Diagnosis of schizophrenia * Wechsler Abbreviated Scale of Intelligence (WASI) intelligence quotient (IQ) \> 85 * Currently taking antipsychotic medication * No change in current psychotropic medications or housing within the past 30 days. Those patients whose medication or housing situation has changed within a month, we will wait list them until their situation stabilizes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Attention: Social Engagement Latency (SEL) | Baseline and social VR post-training (after 8 sessions) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) | Baseline and after 8 sessions of social VR training and after 8 sessions of cognitive training game | 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. |
| Change in Scale for the Assessment of Negative Symptoms (SANS) | 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. | 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 |
| Change in Scale for the Assessment of Positive Symptoms (SAPS) | Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game | 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) |
| Change in Social Outcome: Social Functioning Scale. | 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) |
Countries
United States
Participant flow
Pre-assignment details
Schizophrenia patients undergo both Social VR training and Cognitive Training
Participants by arm
| Arm | Count |
|---|---|
| Social Skills VR Training, Then Cognitive Training Game 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. | 11 |
| Cognitive Training Game, Then Social Skills VR Training 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. | 11 |
| Healthy Controls Healthy controls are recruited to yield comparison data. They do not undergo training.
They are not interviewed for clinical symptoms | 28 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 | 0 |
Baseline characteristics
| Characteristic | Social Skills VR Training, Then Cognitive Training Game | Total | Healthy Controls | Cognitive Training Game, Then Social Skills VR Training |
|---|---|---|---|---|
| Age, Continuous | 43.74 years STANDARD_DEVIATION 12.58 | 40.50 years STANDARD_DEVIATION 13.14 | 33.43 years STANDARD_DEVIATION 15.35 | 45.39 years STANDARD_DEVIATION 11.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 11 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 20 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 16 Participants | 11 Participants | 2 Participants |
| Region of Enrollment United States | 11 participants | 50 participants | 28 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 19 Participants | 15 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 31 Participants | 13 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 28 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 28 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 28 |
Outcome results
Primary
Change in Social Attention: Social Engagement Latency (SEL)
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
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VR Social Skills Training | Change in Social Attention: Social Engagement Latency (SEL) | -195 milliseconds | Standard Deviation 5.6 |
p-value: 0.004t-test, 2 sided
Secondary
Change in Scale for the Assessment of Negative Symptoms (SANS)
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR Social Skills Training | Change in Scale for the Assessment of Negative Symptoms (SANS) | Baseline SANS score | 44.63636364 score on a scale | Standard Error 3.145494582 |
| VR Social Skills Training | Change in Scale for the Assessment of Negative Symptoms (SANS) | After training SANS score | 34.79 score on a scale | Standard Error 3.287917761 |
| Cognitive Training | Change in Scale for the Assessment of Negative Symptoms (SANS) | Baseline SANS score | 44.63636364 score on a scale | Standard Error 3.145494582 |
| Cognitive Training | Change in Scale for the Assessment of Negative Symptoms (SANS) | After training SANS score | 43.67 score on a scale | Standard Error 3.10175999 |
p-value: 0.01ANOVA
Secondary
Change in Scale for the Assessment of Positive Symptoms (SAPS)
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)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR Social Skills Training | Change in Scale for the Assessment of Positive Symptoms (SAPS) | Baseline | 37.86363636 score on a scale | Standard Error 4.145 |
| VR Social Skills Training | Change in Scale for the Assessment of Positive Symptoms (SAPS) | After Training | 28.32 score on a scale | Standard Error 4.776 |
| Cognitive Training | Change in Scale for the Assessment of Positive Symptoms (SAPS) | Baseline | 37.86363636 score on a scale | Standard Error 4.145 |
| Cognitive Training | Change in Scale for the Assessment of Positive Symptoms (SAPS) | After Training | 31.28 score on a scale | Standard Error 4.008 |
p-value: 0.004ANOVA
Secondary
Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A)
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR Social Skills 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 |
| VR Social Skills Training | 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 |
| Cognitive 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 |
| Cognitive Training | Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) | After Training | 13.16 score on a scale | Standard Error 4.88 |
| Healthy Control | Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) | Baseline | 18 score on a scale | Standard Error 0.43 |
p-value: 0.213ANOVA
Secondary
Change in Social Outcome: Social Functioning Scale.
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)
Time frame: Baseline and after 8 sessions of training for social VR and after 8 sessions of active control 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VR Social Skills Training | Change in Social Outcome: Social Functioning Scale. | Baseline | 96.63636364 score on a scale | Standard Error 1.848 |
| VR Social Skills Training | Change in Social Outcome: Social Functioning Scale. | After training | 98.74 score on a scale | Standard Error 1.849 |
| Cognitive Training | Change in Social Outcome: Social Functioning Scale. | Baseline | 96.63636364 score on a scale | Standard Error 1.848 |
| Cognitive Training | Change in Social Outcome: Social Functioning Scale. | After training | 97.56 score on a scale | Standard Error 1.856 |
| Healthy Control | Change in Social Outcome: Social Functioning Scale. | Baseline | 107.25 score on a scale | Standard Error 1.89 |
p-value: >0.05ANOVA