Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention f… (NCT04310475) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
United Kingdom10 participantsStarted 2019-08-23
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment and retention
Timeframe: From start of study until completion of recruitment, approximately 8 months
2
Qualitative feedback from clients and therapists about their experiences
Timeframe: From start of study until completion of intervention, approximately 10 months
3
Study resources
Timeframe: From start of study until completion of intervention, approximately 10 months