NCT05440825 Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation
| NCT ID | NCT05440825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Virtual Reality |
| Study Type | INTERVENTIONAL |
| Enrollment | 171 participants |
| Start Date | 2022-06-23 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 171 participants in total. It began in 2022-06-23 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Catheleine van Driel
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT05440825 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Virtual Reality. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05440825 currently recruiting?
Yes, NCT05440825 is actively recruiting participants. Contact the research team at l.m.robbemond@umcg.nl for enrollment information.
Where is the NCT05440825 trial being conducted?
This trial is being conducted at Enschede, Netherlands, Groningen, Netherlands, Groningen, Netherlands, Groningen, Netherlands and 1 additional location.
Who is sponsoring the NCT05440825 clinical trial?
NCT05440825 is sponsored by University Medical Center Groningen. The principal investigator is Catheleine van Driel at University Medical Center Groningen. The trial plans to enroll 171 participants.