Virtual Reality Assisted CBT for Social Difficulties: a Feasibility Study in Early Intervention for Psychosis Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Recruitment and retention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
Active Treatment
This is a case series
干预措施: Virtual reality assisted CBT (Other)
结局指标
主要结局
Recruitment and retention
时间窗: From start of study until completion of recruitment, approximately 8 months
To assess feasibility and acceptability data will be collected regarding the number of people approached, engaged, dropped out, completed the intervention
Qualitative feedback from clients and therapists about their experiences
时间窗: From start of study until completion of intervention, approximately 10 months
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.
Study resources
时间窗: From start of study until completion of intervention, approximately 10 months
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.
次要结局
- 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)
- Pre and post therapy psychometric assessment - interpersonal sensitivity(Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months)
- Pre and post therapy psychometric assessment - symptom related distress(Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months)
- Pre and post therapy psychometric assessment - loneliness(Start and end of each individual intervention at approximately 10-16 week interval, up to 10 months)
- Progress towards individualized SMART goal(Start, middle and end of each individual intervention within approximately 10-16 week window, up to 10 months)
- Adverse effects(At completion of each intervention or when clients drop out from the study, up to 10 months)
研究者
Dr Lucia Valmaggia
Reader in Clinical Psychology and Digital Mental Health
King's College London