To develop a 360o video VR relaxation program (VRelax) for reducing impact of stress in patients with depressive, anxiety and psychotic disorders. Feasibility, user-friendliness and immediate effects on subjective and objective stress reactivity…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main goal of the study is to investigate the feasibility of the VRelax tool
and to evaluate the efficacy of the tool for reducing subjective and objective
stress, as preparation for a larger RCT.
- Subjective stress: baseline and after last session: Perceived Stress Scale, a
10-item scale to measure the degree to which situations in the last week have
been appraised as stressful. Before and after each session: ecological
momentary assessment single items, assessing perceived stress, anxiety,
paranoia, positive and negative affect on a 1-7 ordinal scale.
- Physiological stress
Heart rate (HR) and skin conductance level (SCL) are recorded on the non-
dominant hand in standing position for 5 minutes at baseline before session 1
but after introduction of the VRelax tool, and for 5 minutes after the first
and after the last session. Skin conductance level (SCL) is measured using a
sensor with two finger electrodes on the middle and ring finger of the same
hand with a sampling rate of 10 Hz. Heart rate (HR) is assessed by non-invasive
pulse wave measurement using a Nexus 4 with a photo-electric plethysmograph on
the index finger.
- Feasibility and user-friendliness will be measured using a qualitative
interview after the last session (e.g., are enough patients willing to
participate?, technical problems, was the intervention pleasurable / helpful,
was the frequency and duration of sessions appropriate?).
Secondary outcome
- Type of VR environment - two conditions will be compared: dolphin and
landscape environments.
- Psychopathology: baseline and after last session: Inventory of Depressive
Symptomatology-Self-Rated, Beck Anxiety Inventory, Green Paranoid Thoughts
Scale.
- Cyber sickness - Simulator sickness questionnaire (SSQ): measures simulator
sickness on symptom level.
- Use of anxiolytic / sedative medication - Information on frequency and dose
of medication use will be collected from the patient file.
- Substance use - Self-report at baseline and before each session, units of
coffee, tea, cigarettes, alcohol, cannabis, illicit drugs last 24 hours or
since previous session.
Background summary
Heightened stress reactivity plays a central role in theories of onset and
course of psychiatric disorders, as it has been related to both onset and
recurrence of mood, anxiety as well as psychotic disorders. Personal stress
reactivity may be altered by changing negative cognitive schemas or reducing
level of arousal, tension and rumination. Changing negative schemas with
cognitive behavioral therapy (CBT) requires great effort of therapists and
patients. Effect sizes of CBT on symptoms are modest in depressive disorders
and schizophrenia. Focusing awareness on the present moment and relaxation by
breathing exercises, imagery visualization and progressive muscle relaxation
may be more directly targeted to breaking the vicious circle of stress
reactivity and psychiatric symptoms. Virtual Reality offers opportunities to
improve relaxation interventions. For reducing stress, arousal and tension,
exposure should be to a relaxing environment, such as a walk in the forest,
scuba diving amidst tropical fishes, or watching the sunset. A combination of
visual and auditory stimuli in VR can be used to create an immersive experience
that is stronger than the individual*s current mental state of distress and
anxiety. Recently, a few preliminary VR stress management studies were
published, suggesting that this is a promising approach for relaxation and
stress recovery, with high potential for further development.
Study objective
To develop a 360o video VR relaxation program (VRelax) for reducing impact of
stress in patients with depressive, anxiety and psychotic disorders.
Feasibility, user-friendliness and immediate effects on subjective and
objective stress reactivity will be investigated.
Study design
In this pilot study, a multidisciplinary team with researchers, clinicians, VR
video experts and intended end-users will develop the intervention. Parts of
the VRelax program will be developed in sprint cycles of three weeks:
a. Development of first prototype in scrum - all team members
b. Testing of first prototype - two clinicians and two end-users
c. Development of second prototype in scrum - all team members
d. Pilot study in order to investigate feasibility and proof of concept, as
preparation for a larger randomized controlled trial (RCT).
Pilot study
Pilot study with 30 subjects. Sample size is based on recommendations for a
clinical pilot as feasibility and proof of concept study. Participants will be
randomly assigned (10 in each condition) to:
a. virtual landscape environment,
b. virtual dolphin environment,
c. control condition: watching 2D video clips of a landscape or dolphins.
Design
After informed consent, patients are randomized to one of the three conditions.
Research assistants will administer baseline measures, including psychiatric
symptoms, subjective and physiological stress measures. Patients will be
instructed to use the VRelax tool or watch the video clips twice daily for 15
minutes, once in the morning and once in the evening. The first session will be
done in the presence of a researcher and a nurse, for technical assistance and
safety. After the first session, subjective and physiological stress measures
are repeated, cyber sickness is assessed and user experiences recorded. From
the second session onwards, patients will use the VRelax / video clips alone.
At day 7, after the last session, a research assistant will repeat the baseline
measures, and will conduct a qualitative interview on user experiences.
Intervention
Patients will be instructed to use the VRelax tool or watch the video clips
twice daily for 15 minutes, once in the morning and once in the evening. The
first session will be done in the presence of a researcher and a research
assistant, for technical assistance and safety. After the first session,
subjective and physiological stress measures are repeated, cyber sickness is
assessed and user experiences recorded. From the second session onwards,
patients will use the VRelax / video clips alone. At day 7, after the last
session, a research assistant will repeat the baseline measures, and will
conduct a qualitative interview on user experiences.
Study burden and risks
Burden:
- pre and post measures: 60 minutes of questionnaires, physiological measures
(heart rate, skin conductance), qualitative interview about user experiences
- twice daily 15 minutes of intervention and 15 minutes preparation / short
questionnaire
Risks:
- cyber sickness in VR, ie, transient nausea or dizziness
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Patient in clinical department of mood/anxiety disorders or psychotic disorders
- DSM-IV diagnosis of depressive disorder, anxiety disorder or psychotic disorder
- Age >18
Exclusion criteria
- DSM-IV diagnosis of substance abuse or dependence
- Specific phobia dolphins or water
- Benzodiazepine use > 10 mg / day diazepam equivalent
- Involuntary admission (IBS or RM)
- Diagnosis of epilepsy or organic brain damage
- Insufficient command of Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57378.042.16 |