The primary objective of the proposed study is to examine the feasibility and acceptability of VR-delivered exposure sessions in a therapy protocol for PTSD. The secondary objective is to test how effective the intervention is in reducing symptoms…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the acceptability and feasibility of the VR
intervention, measured with a self-report questionnaire for evaluation one week
after the final therapy session. Additionally, to test acceptability, a
questionnaire for VR related physical complaints will be used as well as drop
out rate and adverse events.
Secondary outcome
The secondary parameters (PTSD and depression symptoms and well-being) will be
measured before and after the intervention and during a 3 month follow up.
Background summary
Posttraumatic stress disorder (PTSD) is a mental disorder that can occur
following a traumatic event. Current treatments for posttraumatic stress
disorder (PTSD) focus on repeated exposure to the traumatic memory until
extinction of the fear response occurs. Especially in military personnel and
veterans, current treatments are not effective enough in reducing symptoms, for
instance due to high levels of avoidance of the traumatic memory. Virtual
reality (VR) is a promising new treatment strategy due to its immersive
character and quick manipulation of session intensity.
Study objective
The primary objective of the proposed study is to examine the feasibility and
acceptability of VR-delivered exposure sessions in a therapy protocol for
PTSD. The secondary objective is to test how effective the intervention is in
reducing symptoms of PTSD, depression and increasing well-being.
Study design
An open-label uncontrolled feasibility pilot.
Intervention
VR-delivered exposure sessions will be included in the psycho-therapy treatment
protocol for PTSD. During a session, participants will be asked to put on a
head mounted display (HMD) and work through a series of photographs in a
relaxing virtual environment, while in constant contact with their therapist.
Study burden and risks
Participants with PTSD will receive VR exposure therapy. Possible risks could
include VR induced headache or nausea. Increased stress or emotional discomfort
might occur due to exposure to a psychological trauma. However, this is the
case for all trauma-focused therapies. A therapist is always present with the
patient to guide the sessions. Besides the therapy sessions, participants will
complete three assessments which will take 60-90 minutes.
Lundlaan 1
Utrecht 3584EZ
NL
Lundlaan 1
Utrecht 3584EZ
NL
Listed location countries
Age
Inclusion criteria
- Active military personnel or veteran of the Dutch Ministry of Defence.
- Age 18 and up.
- Master the Dutch language
- should have an indication for trauma treatment
- Provide written informed consent.
Exclusion criteria
- Alcohol or substance use disorder.
- Acute psychosis.
- Acute suicidality.
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 | NL80057.041.21 |