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

NCT05440825 | Recruiting

• 1 other identifier: 202100662
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Virtual Reality

Keywords

virtual reality; relaxation; stress; sleep

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Checklist Scale - 90 - R

  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.

  Between T0 and T1 (six weeks)

Secondary Outcomes (25)

• Changes in burn-out symptoms and stress

  Assessment at baseline, six weeks, 26 weeks, and 52 weeks

• Changes in anxiety

  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 depression

  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

Study Arms (2)

VRelax

EXPERIMENTAL

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

Device: VRelax

Relaxation exercises

ACTIVE COMPARATOR

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

Other: Relaxation exercises

Interventions

VRelax 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.

VRelax

Relaxation exercises OTHER

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

Relaxation exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Twente: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (5)

Mediant

Enschede, Netherlands

RECRUITING

Forte GGZ

Groningen, Netherlands

RECRUITING

Lentis

Groningen, Netherlands

RECRUITING

UMCG

Groningen, Netherlands

RECRUITING

Argo GGZ

Lochem, Netherlands

RECRUITING

Study Officials

• Catheleine van Driel

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• Wim Veling

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisanne Robbemond, MSc

CONTACT

+315036114367; l.m.robbemond@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 1, 2022
• Study Start: June 23, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)