Clinical trial NCT04310475: Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
Official title: Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Social Behavior
Paranoia
Social Anxiety
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series, feasibility study
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Recruitment and retention
timeFrame: From start of study until completion of recruitment, approximately 8 months
measure: Qualitative feedback from clients and therapists about their experiences
timeFrame: From start of study until completion of intervention, approximately 10 months
measure: Study resources
timeFrame: From start of study until completion of intervention, approximately 10 months
Secondary outcomes:
measure: Pre and post therapy psychometric assessment - mood
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - anxiety
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - social anxiety 1
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - social anxiety 2
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - paranoid thoughts
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - interpersonal sensitivity
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - symptom related distress
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Pre and post therapy psychometric assessment - loneliness
timeFrame: Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months
measure: Progress towards individualized SMART goal
timeFrame: Start, middle and end of each individual intervention within approximately 10-16 week window, up to 10 months
measure: Adverse effects
timeFrame: At completion of each intervention or when clients drop out from the study, up to 10 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, Psychology and Neuroscience, King's College London
Study officials:
References: