A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Emotion Regulation
研究概览
简要总结
The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.
详细描述
In this protocol, the investigators present a proof-of-concept trial that will evaluate an active psychotherapy and self-management, both targeting emotion regulation skills. The study design is a two-arm randomized controlled trial. The investigators will recruit Inuit and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation, a set of skills or competence that is impacted by traumatic experiences and mediates the effect of trauma on psychiatric symptoms. The investigators conducted a cultural adaptation of the therapy for Inuit with a co-design grounded in qualitative participatory methods. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will include a psychophysiological reactivity paradigm pre-post treatment and self-reports of emotion regulation, anxiety, mood, substance use, functionality and quality of life. The investigators expect to see preliminary evidence that our VR-CBT can be more successful than guided VR relaxation with Calm Place (self-management) decreasing difficulties in emotion regulation, psychiatry symptoms, increasing well-being, and normalizing responses to stressful stimuli (reactivity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identify as Inuk
- •Live in Montreal
- •be between 14 to 60 years of age
- •be proficient in English or French
- •No history of cardiac conditions
- •No history of epilepsy
- •Can provide an emergency contact
- •Tolerance of VR headset
- •Tolerance of sensors
- •Has no current suicidal or homicidal risk
- •No history of psychosis or schizophrenia
- •Current stable mood
- •Is generally mentally stable
- •Score less than 8 on the Alcohol Use Disorders Identification Test C
- •Score less than 3 on the Drug Abuse Screen Test (10 item version)
- •Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study
排除标准
- •does not identify as Inuk
- •youth below the age of 14 and adults above the age of
- •self-reported history of psychosis or schizophrenia
- •current substance abuse, as measured by two screens (AUDIT-C, DAST-10)
- •other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).
结局指标
主要结局
Emotion Regulation
时间窗: Approximately 5 minutes
Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).
次要结局
- emotional valence (momentary)(Approximately 1 hour testing session.)
- Psychiatric Symptoms (alcohol use disorder)(Administration time is between 2 minutes)
- Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)(Approximately 10 minutes)
- Feasibility of interventions (attendance/useage)(10 weeks of intervention period (researcher recorded))
- Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale(Approximately 10 minutes)
- skin conductance response(Approximately 1 hour testing session.)
- heart rate(Approximately 1 hour testing session.)
- anxiety (momentary)(Approximately 1 hour testing session.)
- heart rate variability(Approximately 1 hour testing session.)
- Psychiatric Symptoms (anxiety)(Administration time is around 3 minutes)
- emotional arousal (momentary)(Approximately 1 hour testing session.)
- Psychiatric Symptoms (depression)(Administration time is around 4 minutes)
- Psychiatric Symptoms (post traumatic stress disorder)(Administration time is between 2 minutes)
- Psychiatric Symptoms (substance use disorders)(Administration time is between 4 minutes)
- Feasibility of interventions (treatment completion)(10 weeks of intervention period (researcher recorded))
研究者
Martin Lepage
James McGill professor
Douglas Mental Health University Institute
