Clinical trial NCT05440825: Self-management of Stress and Sleep Disturbances with Virtual Reality Relaxation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Keywords: virtual reality
relaxation
stress
sleep
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Twente
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-07-01
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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)

Primary outcomes:
measure: Change in Symptom Checklist Scale - 90 - R
timeFrame: Between T0 and T1 (six weeks)
Secondary outcomes:
measure: Changes in burn-out symptoms and stress
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in anxiety
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in health and health-related quality of life
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in depression
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in self-reported depressive symptoms
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in mood
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in psychotic symptoms
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in psychosocial functioning
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in quality of life
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in recovery
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Changes in substance use
timeFrame: Assessment at baseline, six weeks, 26 weeks, and 52 weeks
measure: Change in sleep
timeFrame: Assessment at 26 weeks and 52 weeks
measure: Change in medical use, medical cost and productivity losses
timeFrame: Assessment at 26 weeks and 52 weeks
measure: Change in health-related quality of life
timeFrame: Assessment at 26 weeks and 52 weeks
measure: Usability of VRelax
timeFrame: Assessment at 6 weeks
measure: 24 h ambulatory measurement of electrodermal activity, cardiovascular activity, and sleep
timeFrame: The first and last week of using VRelax or relaxation exercises
measure: Daily assessment of sleep
timeFrame: The first and last week of using VRelax or relaxation exercises
measure: Daily pre- and post-session assessments of calness and relaxation
timeFrame: During the use of VRelax or relaxation exercises
measure: Changes in electodermal activity in laboratory setting
timeFrame: Assessment at baseline and six weeks
measure: Changes in cardiovascular activity in laboratory setting
timeFrame: Assessment at baseline and six weeks
measure: Changes in physiological markers for comorbid somatic disease - weight
timeFrame: Assessment at baseline and six weeks
measure: Changes in physiological markers for comorbid somatic disease - height
timeFrame: Assessment at baseline and six weeks
measure: Changes in physiological markers for comorbid somatic disease - waist circumference
timeFrame: Assessment at baseline and six weeks
measure: Changes in physiological markers for comorbid somatic disease - blood pressure
timeFrame: Assessment at baseline and six weeks
measure: Changes in physiological markers for comorbid somatic disease - blood
timeFrame: Assessment at baseline and six weeks
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Mediant
city: Groningen
country: Netherlands
facility: Forte GGZ
city: Groningen
country: Netherlands
facility: Lentis
city: Groningen
country: Netherlands
facility: UMCG
city: Lochem
country: Netherlands
facility: Argo GGZ
Study officials:
affiliation: University Medical Center Groningen
name: Catheleine van Driel
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Wim Veling
role: PRINCIPAL_INVESTIGATOR
References: