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

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Social Skills

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR social skills training
Cognitive training
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, social skills training, social brain network, virtual reality, simulation, functional outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  1. Inclusion and Exclusion Criteria for Individuals with Schizophrenia:

    Inclusion criteria:

    • Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Axis 1 Diagnosis of schizophrenia
    • Wechsler Abbreviated Scale of Intelligence (WASI) intelligence quotient (IQ) > 90
    • 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.

    Exclusion criteria:

    • DSM 5 Axis 1 diagnosis other than schizophrenia
    • Diagnosed organic brain disease, brain lesions, history of head traumas, neurological disorders or other conditions that involve the degeneration of the central nervous system (e.g. multiple sclerosis)
    • Substance/alcohol dependence during the past 1 year
    • Tardive dyskinesia
  2. Inclusion and Exclusion Criteria for Healthy Control Participants:

Inclusion Criteria:

  • WAIS IQ > 90.
  • No DSM-5 Axis 1 diagnosis of psychotic disorders in themselves or their families (e.g. schizophrenia, bipolar disorder).
  • No antipsychotic medications
  • No diagnosed organic brain disease, brain lesions, history of head traumas, neurological disorders or other conditions that involve the degeneration of the central nervous system (e.g. multiple sclerosis)
  • No substance/alcohol dependence during the past 1 year

Sites / Locations

  • Vanderbilt UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

No Intervention

Arm Label

VR Social Skills Training

Cognitive training game

Healthy Controls

Arm Description

Participants will undergo a virtual reality social skills training program for 10 sessions. Each session takes about an hour. Participants visit the lab twice a week. Therefore, the training duration is 5 weeks.

If there is a significant improvement in social skills for the active treatment condition, the reason might be that the participants were exposed to social environment by coming to the lab and interacting with the research staff twice a week for 5 weeks and/or they used a computerized training tool twice a week for 5 weeks. In order to control for these potential confounds, we included a cognitive training arm. Participants will undergo a commercially available cognitive training program for ten 1-hour sessions (twice a week for 5 weeks).

Healthy controls are recruited to yield comparison data. They do not undergo training.

Outcomes

Primary Outcome Measures

Change in Social Attention: Social Engagement Latency (SEL)
Social engagement latency is defined as the time taken to select an avatar to interact with. SE: is measured in milliseconds. This is the targeted mechanism identified in a previous R21 study.
Change in Social Brain Network Activity
fMRI of social simulation task will identify the brain networks that are engaged during a social simulation task (see Thakkar, Peterman and Park. American Journal of Psychiatry. 2014)

Secondary Outcome Measures

Change in Social Emotion Recognition (BLERT)
BLERT (Bell-Lysaker Emotion Recognition Task; Bell et al, 1997). BLERT measures social cognition in people with schizophrenia and it has been reported to have the strongest psychometric properties for use in clinical trials. BLERT presents 21, 10-second video clips to measure the ability to identify seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion.
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 subscale has a single item global score for overall severity of each symptom domain. Each item is rated for severity from least (0) to most severe (5). 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)
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 (rating=5) 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 (SFS; Birchwood, 1990). This is a well validated measure used to assess social functioning. SFS consists of 76 items (7 subscales). Every subscale value is normalized to a Scaled Score (Mean = 100, SD = 15). The SFS full scale score is the mean of the 7 subscales scaled scores. The 7 subscales are: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance and employment.

Full Information

First Posted
June 26, 2019
Last Updated
December 7, 2022
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT04005794
Brief Title
Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training
Official Title
Physiology-based Virtual Reality Training for Social Skills in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. ' The next phase, supported by a R33 grant will compare the VR social skills training with a control condition. This new protocol includes a control condition for the exposure to computerized training across the 10 sessions and incidental exposure to social interactions (i.e. interactions with experimenters twice a week for 5 weeks) by including a control condition, which involves computerized brain fitness training for 10 sessions.
Detailed Description
The effectiveness of the social VR training (n=20) at an optimal dose will be compared with an active control condition (computerized cognitive training) (n=20) in improving social attention (Social Engagement Latency: SEL) and social brain network in a pilot randomized control trial (RCT). Participants with schizophrenia will undergo a baseline assessment of cognition, social functioning, symptoms and social brain network functioning. These behavioral, clinical and functional neuroimaging (fMRI of social imitation task, and resting state connectivity analyses of the social brain network) methods will be used to assess changes. Individuals with schizophrenia will be randomized to either the social skills training or the computerized cognitive training at baseline. They will then participate in 10 sessions of social skills VR training or computerized cognitive training (1 hour per session, twice a week for 5 weeks). In addition, long-term social outcome will be assessed approximately 2 months after the end of training with 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). For the long-term outcome assessment, no neuroimaging or behavioral assessments will be conducted because the primary goal of the follow-up is to assess broad levels of social functioning in the real world and because there is not sufficient time within the R33 mechanism. 16 matched control participants will be recruited to obtain behavioral and neuroimaging 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 adaptive VR technology shows that it can improve social attention, which in turn improves 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Social Skills
Keywords
schizophrenia, social skills training, social brain network, virtual reality, simulation, functional outcome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two conditions are compared in individuals with schizophrenia: VR social training and active control condition of computerized cognitive training. 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.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants with schizophrenia and Outcome assessors will be blind to the training condition.
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR Social Skills Training
Arm Type
Active Comparator
Arm Description
Participants will undergo a virtual reality social skills training program for 10 sessions. Each session takes about an hour. Participants visit the lab twice a week. Therefore, the training duration is 5 weeks.
Arm Title
Cognitive training game
Arm Type
Other
Arm Description
If there is a significant improvement in social skills for the active treatment condition, the reason might be that the participants were exposed to social environment by coming to the lab and interacting with the research staff twice a week for 5 weeks and/or they used a computerized training tool twice a week for 5 weeks. In order to control for these potential confounds, we included a cognitive training arm. Participants will undergo a commercially available cognitive training program for ten 1-hour sessions (twice a week for 5 weeks).
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Healthy controls are recruited to yield comparison data. They do not undergo training.
Intervention Type
Behavioral
Intervention Name(s)
VR social skills training
Intervention Description
Social skills game that we developed in the R21 phase will be used across 10 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Social Attention: Social Engagement Latency (SEL)
Description
Social engagement latency is defined as the time taken to select an avatar to interact with. SE: is measured in milliseconds. This is the targeted mechanism identified in a previous R21 study.
Time Frame
Baseline and 5 weeks.
Title
Change in Social Brain Network Activity
Description
fMRI of social simulation task will identify the brain networks that are engaged during a social simulation task (see Thakkar, Peterman and Park. American Journal of Psychiatry. 2014)
Time Frame
Baseline and 5 weeks.
Secondary Outcome Measure Information:
Title
Change in Social Emotion Recognition (BLERT)
Description
BLERT (Bell-Lysaker Emotion Recognition Task; Bell et al, 1997). BLERT measures social cognition in people with schizophrenia and it has been reported to have the strongest psychometric properties for use in clinical trials. BLERT presents 21, 10-second video clips to measure the ability to identify seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion.
Time Frame
Baseline and 5 weeks.
Title
Change in Scale for the Assessment of Negative Symptoms (SANS)
Description
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 subscale has a single item global score for overall severity of each symptom domain. Each item is rated for severity from least (0) to most severe (5). Andreasen NC: Scale for the Assessment of Negative Symptoms (SANS) . Iowa City, University of Iowa, 1983
Time Frame
Baseline and 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended.
Title
Change in Scale for the Assessment of Positive Symptoms (SAPS)
Description
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 (rating=5) 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 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended.
Title
Change in Social Outcome
Description
Social Functioning Scale (SFS; Birchwood, 1990). This is a well validated measure used to assess social functioning. SFS consists of 76 items (7 subscales). Every subscale value is normalized to a Scaled Score (Mean = 100, SD = 15). The SFS full scale score is the mean of the 7 subscales scaled scores. The 7 subscales are: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance and employment.
Time Frame
Baseline and 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion and Exclusion Criteria for Individuals with Schizophrenia: Inclusion criteria: Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Axis 1 Diagnosis of schizophrenia Wechsler Abbreviated Scale of Intelligence (WASI) intelligence quotient (IQ) > 90 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. Exclusion criteria: DSM 5 Axis 1 diagnosis other than schizophrenia Diagnosed organic brain disease, brain lesions, history of head traumas, neurological disorders or other conditions that involve the degeneration of the central nervous system (e.g. multiple sclerosis) Substance/alcohol dependence during the past 1 year Tardive dyskinesia Inclusion and Exclusion Criteria for Healthy Control Participants: Inclusion Criteria: WAIS IQ > 90. No DSM-5 Axis 1 diagnosis of psychotic disorders in themselves or their families (e.g. schizophrenia, bipolar disorder). No antipsychotic medications No diagnosed organic brain disease, brain lesions, history of head traumas, neurological disorders or other conditions that involve the degeneration of the central nervous system (e.g. multiple sclerosis) No substance/alcohol dependence during the past 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sohee Park, Ph.D.
Phone
6153220884
Email
sohee.park@vanderbilt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Sangimino, B.A.
Phone
6153223435
Email
michael.j.sangimino@vanderbilt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sohee Park, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sohee Park, Ph.D.
Phone
615-322-3435
Email
sohee.park@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Michael S Sangimino, B.A.
Phone
6153223435
Email
michael.j.sangimino@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Nilanjan Sarkar, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We are comparing a social skills game in virtual reality with a cognitive training software. After the study is completed, we will make the protocol and the methods available to all those who request this information.
IPD Sharing Time Frame
After the study has ended and we have been able to publish the outcome of the study. This is expected to be within 2 years of the completion of the study.
IPD Sharing Access Criteria
Interested parties should contact the P.I. by email.
Citations:
PubMed Identifier
30326433
Citation
Adery LH, Ichinose M, Torregrossa LJ, Wade J, Nichols H, Bekele E, Bian D, Gizdic A, Granholm E, Sarkar N, Park S. The acceptability and feasibility of a novel virtual reality based social skills training game for schizophrenia: Preliminary findings. Psychiatry Res. 2018 Dec;270:496-502. doi: 10.1016/j.psychres.2018.10.014. Epub 2018 Oct 9.
Results Reference
result
PubMed Identifier
30921747
Citation
Torregrossa LJ, Bian D, Wade J, Adery LH, Ichinose M, Nichols H, Bekele E, Sarkar N, Park S. Decoupling of spontaneous facial mimicry from emotion recognition in schizophrenia. Psychiatry Res. 2019 May;275:169-176. doi: 10.1016/j.psychres.2019.03.035. Epub 2019 Mar 20.
Results Reference
result
PubMed Identifier
30627303
Citation
Wade J, Nichols HS, Ichinose M, Bian D, Bekele E, Snodgress M, Amat AZ, Granholm E, Park S, Sarkar N. Extraction of Emotional Information via Visual Scanning Patterns: A Feasibility Study of Participants with Schizophrenia and Neurotypical Individuals. ACM Trans Access Comput. 2018 Nov;11(4):23. doi: 10.1145/3282434.
Results Reference
result

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

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