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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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VRelax

Participants will be using Virtual Reality relaxation (VRelax) in addition to treatment as usual

Group Type EXPERIMENTAL

VRelax

Intervention Type DEVICE

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 Tibetan sound bowls.

Relaxation exercises

Participants will be using relaxation exercises in addition to treatment as usual

Group Type ACTIVE_COMPARATOR

Relaxation exercises

Intervention Type OTHER

Relaxation exercises consisting of audio-guided breathing exercises, muscle relaxation exercises, and body scan exercises

Interventions

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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 Tibetan sound bowls.

Intervention Type DEVICE

Relaxation exercises

Relaxation exercises consisting of audio-guided breathing exercises, muscle relaxation exercises, and body scan exercises

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No