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临床试验/NCT05631743
NCT05631743已完成不适用

A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial

Douglas Mental Health University Institute3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年7月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Lepage

James McGill professor

Douglas Mental Health University Institute

研究点 (3)

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