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

Stress is a well-established factor in the onset and continuation of burn-out
anxiety, mood, psychotic, and post-traumatic 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 effective, it must be taken into
account that they require mental effort (i.e. attention and concentration of
patients). These skills are often impared in people with burn-out or
psychiatric disorders

To bridge this gap, VRelax was developed. VRelax is a virtual reality
self-management stress-reduction tool. 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 with treatment as
usual on symptomatic recovery, level of social functioning, healthcare
consumption and societal costs will be investigated.

To test the effectiveness and cost-effectiveness of adding VRelax to treatment
as usual (TAU) in improving functional and symptomatic outcomes in patients
with anxiety, bipolar, burn-out, depressive, psychotic or post-traumatic
disorder compared to TAU with regulated use of relaxation exercises.

Multi-centre single-blind randomized controlled trial (RCT) with two arms:
VRelax + treatment as usual and treatment as usual + regulated use of
relaxation exercises.

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 standalone head mounted display,
through which they can access the VRelax app. The VRelax app contains 360* VR
videos of relaxing natural environments. The variety of landscapes includes
beaches, mountains, being in proximity to animals, etc. Interactive elements
are embedded in the videos, e.g., a game of popping underwater air bubbles,
shooting stars in a night sky and audio tracks of relaxation exercises.
Participants use VRelax for a minimum of 20 minutes, at least five days a week
for six weeks. The VRelax intervention is compared to treatment as usual with
regulated use of relaxation exercises. The relaxation exercises consist of
recorded texts of breathing exercises, muscle relaxation and guided meditation.
The use of the relaxation exercises is regulated (minimum 20 minutes per day,
minimum of five days per week, for six weeks) to ensure the same is demanded of
these participants.

Assessments will take place at four time points (baseline [T0], post-treatment
[T1], 26 weeks after baseline [T2] and 52 weeks after baseline [T3]).

The assessments at T0 and T1 include questionnaires, interviews, physical
examination (including weight, blood pressure, and blood sampling), and
physiological measurements in a lab setting at the UMCG and will take
approximately 120-180 minutes.
The (online) assessments at T2 and T3 include questionnaires and interviews and
will take 100-120 minutes.

Participants will use VRelax or relaxation exercises at least once a day, five
days a week, for six weeks and complete pre and post-session assessments (20 x
5 x 6 = 600 minutes).
The daily assessment consists of six questions and will take 1 - 2 minutes to
complete (5 x 6 x 1-2 minutes = 30-60 minutes).

Only for two weeks, participants will fill in the daily sleep questionnaire.
The daily sleep questionnaire consists of four questions and will take 1 minute
to complete (1 x 7 x 2 = 14 minutes)

We expect the patients to benefit from both the VRelax tool as the relaxation
exercises. Concerning VRelax, it is possible some patients may experience mild
cyber sickness during VRelax, i.e. transient nausea or dizziness. No major
adverse events are expected or have been documented.