Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство VRelax
  Virtual Relaxation relaxation, VRelax, includes a collection of high quality 360° degrees videos of nature environments with 3D audio and interactive elements, created for relaxation, stress-reduction and improving sleep. When activated, the participant can choose specific 360° videos from a menu. The 360° videos include among other things a coral reef with an interactive game element of popping air bubbles, a scuba diving experience with dolphins, a mountain meadow with cows, and a session of T
• Другое Relaxation exercises
  Relaxation exercises consisting of audio-guided breathing exercises, muscle relaxation exercises, and body scan exercises

Первичные конечные точки

• Change in Symptom Checklist Scale - 90 - R [Срок оценки: Between T0 and T1 (six weeks)]

Вторичные конечные точки (12)

• Changes in burn-out symptoms and stress [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in anxiety [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in health and health-related quality of life [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in depression [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in self-reported depressive symptoms [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in mood [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in psychotic symptoms [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in psychosocial functioning [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in quality of life [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in recovery [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Changes in substance use [Срок оценки: Assessment at baseline, six weeks, 26 weeks, and 52 weeks]
• Change in sleep [Срок оценки: Assessment at 26 weeks and 52 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 5 центров

• Mediant — Enschede
• Forte GGZ — Groningen
• Lentis — Groningen
• UMCG — Groningen
• Argo GGZ — Lochem

Публикации

• Robbemond LM, van Driel CMG, Scholten N, Veling W, Noordzij ML. The Impact of Self-Managed Virtual Reality Relaxation on Non-invasive Ambulatory Physiological Markers in Home-Based Psychiatric Care. Appl Psychophysiol Biofeedback. 2026 Jul 6. doi: 10.1007/s10484-026-09796-4. Online ahead of print. PMID 42406301

Идентификаторы

NCT: NCT05440825 · 202100662

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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