Viewing Study NCT04310475



Ignite Creation Date: 2024-05-06 @ 2:26 PM
Last Modification Date: 2024-10-26 @ 1:30 PM
Study NCT ID: NCT04310475
Status: COMPLETED
Last Update Posted: 2022-04-08
First Post: 2020-03-10

Brief Title: Virtual Reality Assisted CBT for Social Difficulties a Feasibility Study in Early Intervention for Psychosis Services
Sponsor: Kings College London
Organization: Kings College London

Study Overview

Official Title: Virtual Reality Assisted CBT for Social Difficulties a Feasibility Study in Early Intervention for Psychosis Services
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: Participants will be offered up to 10 sessions including a pre and post assessment session Each participant will set one or more SMART goals for therapy eg be able to use public transport attend a social gathering or to feel less anxious in social situations which are worked on both in the therapy sessions and through homework tasks

This is a feasibility study The aim is to recruit between 6-10 participants to pilot the VRT with The results of this study will inform future research and practice by helping to assess if service-users find the new VRT acceptable eg recruitment retention drop out rates participant experiences and if it is effective eg reduction in symptoms or distress and improvement in social functioning

It is really important that the clinical care of anyone who chooses to participate in the study is not affected by their participation in this study The researchers will work closely with clinical teams to ensure this Clients who engage with the study will still be eligible for all aspects of TAU including psychological interventions should this be appropriate

The VR technology and environment has been used extensively before in research studies which have proved that it is safe and effective However it has not been used within the NHS context before or embedded within a therapy course before

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None