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

NCT ID: NCT04310475

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2020-10-01

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 (e.g. 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 (e.g. recruitment, retention, drop out rates, participant experiences), and if it is effective (e.g. 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.

Conditions

Psychosis; Social Behavior; Paranoia; Social Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment

This is a case series

Group Type: EXPERIMENTAL

Virtual reality assisted CBT

Intervention Type: OTHER

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

Interventions

Virtual reality assisted CBT

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Dr Lucia Valmaggia

Reader in Clinical Psychology and Digital Mental Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

255964

Identifier Type: -

Identifier Source: org_study_id