Virtual Reality Training for Social Skills in Schizophrenia

NCT03128099 | Completed Results DMC

• 1 other identifier: MH106748
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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, we must 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. The investigators will test 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. VR technology offers a flexible alternative to conventional therapies, with several advantages, including a simplified and low-stress social interaction environment with targeted opportunities to simulate, exercise and reinforce basic elements of social skills in a very wide range of realistic scenarios, and to repeat exposure to naturalistic situations from multiple angles.

Conditions

Schizophrenia

Keywords

Social Skills; Social attention; Virtual reality; Eye tracking

Outcome Measures

Primary Outcomes (1)

• Social Attention: Social Engagement Latency (SEL)

  Social Engagement Latency (SEL), defined as the time taken to select an avatar by fixating eye gaze at the chosen avatar's face to initiate a new social 'mission'. This is an ecologically valid index that corresponds to one's readiness to initiate a social interaction. To start a social 'mission', the participant must choose an avatar by fixating on a semi-transparent green patch that covers the avatar's face. When the participant fixates on the avatar's face, the green patch disappears to reveal the avatar's face, which starts the social mission game. The time takes to remove the green patch to reveal the avatar's face is the SEL, our primary social attention target and a useful index of pro-social attention engagement.

  5 weeks

Study Arms (3)

Low dose VR social skills training

EXPERIMENTAL

In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.

Behavioral: Virtual reality social skills training

High dose Low dose VR social skills training

EXPERIMENTAL

In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.

Behavioral: Virtual reality social skills training

Healthy Control Participants

NO INTERVENTION

23 healthy control participants were recruited and consented to yield baseline comparison data. These participants did not undergo VR training. Only baseline comparison data were collected.

Interventions

Virtual reality social skills training BEHAVIORAL

Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention

Also known as: physiology based virtual reality social skills training

High dose Low dose VR social skills training; Low dose VR social skills training

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Individuals with Schizophrenia:
• DSM-5 Axis 1 Diagnosis of schizophrenia
• No DSM 5 Axis 1 diagnosis other than schizophrenia
• 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 abuse/dependence during the past 1 year
• No tardive dyskinesia
• WASI 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.
• 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 abuse/dependence during the past 1 year
• WAIS IQ \> 90.

Sponsors & Collaborators

• Vanderbilt University: lead
• University of California, San Diego: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

Related Publications (4)

• 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.

  PMID: 30326433 RESULT

• 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.

  PMID: 30921747 RESULT

• 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.

  PMID: 30627303 RESULT

• Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

  PMID: 33539561 DERIVED

MeSH Terms

Conditions

Schizophrenia; Social Skills

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Sohee Park, Project Director
• Organization: Vanderbilt University

sohee.park@vanderbilt.edu

6153223435

Study Officials

• Sohee Park, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Nilanjan Sarkar, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are assigned to low or high dose randomly. They do not know which condition they are in. The research staff who assess symptoms before and after training do not know which condition the participant is assigned to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Half the participants play the virtual reality video game for one hour per session (low dose). The other half play the virtual reality video game for 2 hours per session (high dose). Both groups visit the lab 10 times ( twice a week for 5 weeks)

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 25, 2017
• Study Start: June 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)