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Self-management of stress and sleep disturbances with eHealth applications for people with burn-out, mood, anxiety or psychotic disorders

Self-management of stress and sleep disturbances with eHealth applications for people with burn-out, mood, anxiety or psychotic disorders - Relax-XL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54388
Enrollment
171
Registered
2022-02-28
Start date
2022-06-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

burn-out, bipolaire, depressieve, psychotische en posttraumatische stressstoornissen anxiety anxiety disorders

Interventions

VRelax is a VR self-management tool aimed at reducing stress and sleep disturbances that can be used as a self-help intervention at home without the guidance of a professional. Patients wear a stand

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Currently receiving treatment for burn-out which is defined according to the Dutch GP *Overspanning en burn-out* guideline, and includes the International Classification of Primary Care (ICPC) categories of *surmenage* (P78) and *burn-out*(Z29.01), or diagnosed with anxiety disorder, bipolar disorder, depressive disorder, psychotic disorder or post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM), 5th edition. - Complaints of stress and/or sleep disturbances as reported by patient or therapist - Age > 18 .

Exclusion criteria

Exclusion criteria: - DSM-5 diagnosis of substance use disorder. - Photosensitive epilepsy with seizure in the past year or organic brain damage. - Intellectual disability (estimated IQ

Design outcomes

Primary

MeasureTime frame
Primary outcome is level of symptoms measured with the Dutch version of the Symptom Checklist-90-Revised (SCL-90-R). Participants will complete the SCL-90-R at baseline (T0) and after six weeks of using VRelax or controlled use of relaxation exercises (T1).

Secondary

MeasureTime frame
The secondary outcomes are psyciatric symptoms (measured with BAI, PSYRATS, HRSD, BAT, MDQ, and PCL-5) psychosocial functioning and medication use (measured with WHO-DAS II), functioning and recovering (measured with MANSA and Recovery Assessment Scale), substance use (measured with ASSIST), perceived stress (measured with perceived stress scale), sleep (measured with PSQI), cost-effectiveness (measured with TiC-P and EQ-5D-5L) and physical health (measured with SF-36). Three questions are asked about preferences for VRelax or relaxation exercises, personal experiences that participants bring after using VRelax or relaxation exercises, and activities undertaken regarding stress and stress management. Level of calmness and relaxation will be measured daily with Visual Analogue Scales. Physiological parameters of stress and sleep will be measured during the intervention period using ambulatory measurements. In addition, a daily sleep questionnaire is administered to gain a better understanding of sleep. Physiological parameters of stress will also be measured in a lab setting at the UMCG. Physiological markers of comorbid somatic diseases are measured by physical examination (including weight, blood pressure, and blood sampling).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026