The study is a first step towards investigating whether VR, and more specifically changing automatic negative thoughts (ANT) and doing role play in a virtual world, is effective in treatment of a depressive disorder.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the severity of depressive symptoms (item-total correlation
of QIDS-SR).
Secondary outcome
Secondary outcomes are the severity of ANT (5 items of ATQ-30) and the extent
of social avoidance behavior (subscale Social Impairment BADS). It is also
examined whether these independent variables have a mediating role in the
severity of depressive symptoms. Exploratory research is conducted into the
extent to which the VR environment is perceived as realistic (IPQ) and patients
are satisfied with VR (SRS).
Background summary
Although cognitive behavioral therapy (CBT) is an effective psychotherapy for
depression, previous research shows that only 40-60% of patients with
depression benefit from CBT. The CBT techniques aimed at challenging automatic
negative thoughts and reducing (social) avoidance behavior in the current form
may not work sufficiently enough. Innovations such as Virtual Reality (VR) can
change this. VR is already regularly applied in treatment practice, but the
effectiveness in treating depression has not yet been investigated.
Study objective
The study is a first step towards investigating whether VR, and more
specifically changing automatic negative thoughts (ANT) and doing role play in
a virtual world, is effective in treatment of a depressive disorder.
Study design
It is a nonconcurrent randomized multiple baseline single case experimental
design (SCED) consisting of two phases (A and B). The primary outcome measure
(severity of depressive symptoms) is measured regularly, with a total of 27-33
measurement moments.
Intervention
After a randomized baseline waiting list period, ranging from 4-6 weeks, each
participant follows the same intervention according to the VR-CBT treatment
protocol for depression (VR-CGT-D). The treatment protocol consists of five
weekly sessions of 45-60 minutes.
Study burden and risks
Filling in the questionnaires adds extra time (3-3.5 hours) to the regular
duration of treatment. In addition, a number of participants will have to wait
longer with the start of the intervention than others due to randomization
(although the waiting list period within the study will usually be shorter than
the regular waiting time for treatment). All participants receive
evidence-based CBT for depression, to which VR is added. Regular CBT
interventions, namely changing negative thoughts and doing role plays, are
performed in a virtual environment. The largest symptom reduction is expected
within 4 weeks. In the unlikely event of no positive treatment effect,
participants can quickly follow another therapy, given the relatively
short-term intervention. No serious side effects are expected.
Sint Jorisweg 2
Delft 2612 GA
NL
Sint Jorisweg 2
Delft 2612 GA
NL
Listed location countries
Age
Inclusion criteria
- Major depressive disorder according to the Diagnostic and Statistical Manual,
5th edition
- Age between 18 and 65 years.
- In possession of a smartphone with internet access.
- Proficiency in the Dutch language (spoken and written). Participants must be
able to follow therapy in Dutch and read Dutch questionnaires.
Exclusion criteria
- An acute risk of suicide, estimated by the practitioner by means of a suicide
assessment.
- A co-morbid psychotic disorder.
- Co-morbid alcohol and / or drug dependence.
- Mental retardation.
- Participation in other psychological treatments during the research.
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 | NL70992.078.19 |