Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services

NCT04310475 | Completed DMC

• 1 other identifier: 255964
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

People experiencing psychosis might find social interactions stressful and avoid them. This can result in isolation and can affect relationships, employment and quality of life. Improving social functioning is a really important aspect of recovery. Facing social situations after the first episode of psychosis can be very difficult and provoke intense anxiety. However, research has shown that the earlier intervention is offered, the better the outcome. Therefore, improving therapies for people experiencing their first episode of psychosis is a key target for research. Virtual Reality presents a unique opportunity to bring real-life-type environments into a therapy session to help people to overcome their distress in social situations and make them feel less anxious. Virtual Reality assisted Therapy (VRT) provides a 'safe space' to practice strategies and techniques to help people work towards improving their social functioning, build new ways of coping with stress and assist them in their recovery. The study uses a standard CBT model and integrates a Virtual Reality environment into it to support exposure and behavioural experiments for social difficulties, which are a key component of treatment.

Conditions

Psychosis; Social Behavior; Paranoia; Social Anxiety

Outcome Measures

Primary Outcomes (3)

• Recruitment and retention

  To assess feasibility and acceptability data will be collected regarding the number of people approached, engaged, dropped out, completed the intervention

  From start of study until completion of recruitment, approximately 8 months

• Qualitative feedback from clients and therapists about their experiences

  To assess feasibility and acceptability feedback from clients and therapists about the experience of the receiving and/or delivering the intervention will be regularly sought via interview.

  From start of study until completion of intervention, approximately 10 months

• Study resources

  To assess feasibility and acceptability the resources required for the intervention will be recorded (e.g. from training and supervising therapists, to room space, technological kit and support required etc.) as observations.

  From start of study until completion of intervention, approximately 10 months

Secondary Outcomes (10)

• Pre and post therapy psychometric assessment - mood

  Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months

• Pre and post therapy psychometric assessment - anxiety

  Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months

• Pre and post therapy psychometric assessment - social anxiety 1

  Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months

• Pre and post therapy psychometric assessment - social anxiety 2

  Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months

• Pre and post therapy psychometric assessment - paranoid thoughts

  Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months

Study Arms (1)

Active Treatment

EXPERIMENTAL

This is a case series

Other: Virtual reality assisted CBT

Interventions

Virtual reality assisted CBT OTHER

This study uses virtual reality technology to assist cognitive behavioural therapy for social difficulties in people with first episode psychosis.

Active Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant must be under the care of an approved research site throughout the period of the study i.e. local early intervention for psychosis clinical team
• The participant must be aged 18-65 and speak English to a conversational level.
• The participant must have experienced or currently be experiencing psychosis, as defined by ICD-10 and DSM-V criteria.
• The participant must have the capacity to consent to the study
• The participant should be experiencing difficulties in social situations (e.g. due to paranoia, social anxiety, poor social skills, low mood or lack of social motivation)

You may not qualify if:

• The participant must not have a history of epilepsy OR photosensitivity (any other comorbidity is fine).
• The participant must not currently be in receipt of another psychological therapy at the time of the study (before or after the study is fine).

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Institute of Psychiatry, Psychology and Neuroscience, King's College London

London, United Kingdom

Location

MeSH Terms

Conditions

Psychotic Disorders; Social Behavior; Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Clinical Psychology and Digital Mental Health

Model Details: Case series, feasibility study

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: August 23, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)