Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation for People with Burn-out, Mood, Anxiety or Psychotic Disorders: a Single-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 171
- 试验地点
- 5
- 主要终点
- Change in Symptom Checklist Scale - 90 - R
研究概览
简要总结
Stress is a well-established factor in the onset and continuation of burn-out anxiety, mood and psychotic disorders. Furthermore, sleep disturbances predispose and exacerbate mental health symptoms of the condition. In people with mental health problems, higher (social) stress-reactivity and impaired stress-recovery are present which is further aggravated by sleep disturbances and sleep deprivation. Relaxation reduces the stress, which in turn may reduce mental health symptoms, improve daily life functioning and quality of life. The burden of burn-out and psychiatric illness can be decreased by stress-reducing interventions which have been shown to improve quality of life and social and occupational functioning. Although current stress-reducing interventions appear to be efficacious, it must be taken into account that they require mental effort (i.e. attention and concentration of patients) which is often impaired in patients. To bridge this gap, a new e-Health application was developed called VRelax. VRelax is a virtual reality self-management stress-reduction tool (VRelax). This tool requires far less effort than traditional relaxation exercises due to its immersive properties, and has an immediate effect on perceived stress and emotional mental states. In this study, the short-, medium- and long term effect of VRelax + treatment as usual (TAU) compared to TAU and relaxation exercises on symptomatic recovery, level of social functioning, healthcare consumption and societal costs will be investigated.
详细描述
Once participants consent, they will complete the first assessment (T0). T0 starts with a physical assessment that consist of measuring weight, height, and waist circumference, a blood pressure test and a blood test. Furthermore, they will complete an assessment of physiological parameters during the use of VRelax. Then participants will complete a couple demographic questions, the Symptom Checklist-90-revised (SCL-90-R), the WHO Disability Assessment Schedule (WHO-DAS), the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), the Hamilton Rating Scale for Depression (HRSD), and the Psychotic Symptom Rating Scales (Psyrats). Participants will then be informed to wear to different wearables for two weeks (Empatica E4 and MotionWatch 8). The instruction is to wear the Empatica E4 during the day to measure their Heart Rate (HR), Heart Rate Variability (HRV), and Skin Conductance (SC). The MotionWatch 8 will be worn during the night to measure their sleep. Participants also receive the instruction to complete the following online questionnaires at home: Burn-out Assessment Tool (BAT), Beck Anxiety Inventory (BAI), Inventory of Depressive Symptomatology Self Reported (IDS-SR), Mood Disorder Questionnaire (MDQ), Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), Manchester Short Assessment of Quality of Life (MANSA), Recovery Assessment Scale - domains and stages (RAS-DS), Treatment Inventory of Costs in Patients (TiC-P), 36-item Short Form Survey (SF-36), and EQ-5D-5L.
Participants receive from their healthcare professional either VRelax or relaxation exercises with the instruction to use this for at least 20 minutes a day, at least five days a week, for six weeks. During those six weeks, participants will wear the wearables (Empatica E4 and MotionWatch 8) the first and the last week.
After six weeks after the first assessment, participants will complete the second assessment (T1). T1 is identical to T0 plus the System Usability Scale (SUS) for the participants who used VRelax. After 26 weeks after the first assessment, participants will complete the third assessment (T2). T2 consists of SCL-90-R, WHO-DAS, ASSIST, HRSD, Psyrats, BAT, BAI, IDS-SR, MDQ, PSS, PSQI, MANSA, TiC-P, SF-36, and EQ-5D-5L. The fourth and final assessment (T3) is 52 weeks after the first assessment. T3 is identical to T2.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receiving treatment for burn-out, anxiety disorder, bipolar disorder, post-traumatic stress disorder, depressive disorder and/or psychotic disorder.
- •Complaints of stress and/or sleep disturbances as reported by patient or therapist
- •Age > 18
排除标准
- •Individuals with a DSM-5 classification of substance use disorder
- •Individuals with photosensitive epilepsy with seizure in the past year or organic brain damage
- •Individuals with insufficient command of Dutch language
- •Individuals with intellectual disability (estimated IQ < 70)
结局指标
主要结局
Change in Symptom Checklist Scale - 90 - R
时间窗: Between T0 and T1 (six weeks)
The SCL-90-R is used to evaluate a broad range of psychological problems and symptoms of psychopathology during the last week.The SCL-90-R consists of 90 items scored on a five-point Likert scale.
次要结局
- Changes in depression(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in health and health-related quality of life(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in mood(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in quality of life(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Change in health-related quality of life(Assessment at 26 weeks and 52 weeks)
- Changes in electodermal activity in laboratory setting(Assessment at baseline and six weeks)
- Changes in anxiety(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in burn-out symptoms and stress(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in self-reported depressive symptoms(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Change in sleep(Assessment at 26 weeks and 52 weeks)
- Change in medical use, medical cost and productivity losses(Assessment at 26 weeks and 52 weeks)
- 24 h ambulatory measurement of electrodermal activity, cardiovascular activity, and sleep(The first and last week of using VRelax or relaxation exercises)
- Changes in physiological markers for comorbid somatic disease - waist circumference(Assessment at baseline and six weeks)
- Usability of VRelax(Assessment at 6 weeks)
- Changes in psychotic symptoms(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in psychosocial functioning(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in recovery(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in physiological markers for comorbid somatic disease - height(Assessment at baseline and six weeks)
- Changes in physiological markers for comorbid somatic disease - blood pressure(Assessment at baseline and six weeks)
- Changes in substance use(Assessment at baseline, six weeks, 26 weeks, and 52 weeks)
- Changes in physiological markers for comorbid somatic disease - blood(Assessment at baseline and six weeks)
- Daily assessment of sleep(The first and last week of using VRelax or relaxation exercises)
- Daily pre- and post-session assessments of calness and relaxation(During the use of VRelax or relaxation exercises)
- Changes in cardiovascular activity in laboratory setting(Assessment at baseline and six weeks)
- Changes in physiological markers for comorbid somatic disease - weight(Assessment at baseline and six weeks)