Feasibility is assessed after every VR-EMDR session and after treatment completion. PTSD symptoms, quality of life and self-empowerment are assessed before and after treatment.
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the feasibility and the safety of the application
of VR as an add-on to treatment as usual. This is measured using Visual
Analogue Scales (VAS) after every VR session and a semi-structured interview
after treatment is completed.
Secondary outcome
Severity of PTSD symptoms, quality of life and empowerment are all examined
using short questionnaires. These are administered before the start of
treatment and after treatment completion. In addition, de questionnaire on PTSD
symptom severity is administered before every VR-EMDR session.
Background summary
Despite the existence of effective trauma-focused treatment for PTSD, such as
Eye Movement Desensitization and Reprocessing (EMDR), not all veterans with
PTSD seem to benefit from this sufficiently. The application of Virtual Reality
(VR) and high intensity treatment are relatively new interventions that look
promising. In addition, it seems that home interventions, such as eHealth, are
effective in PTSD treatment. Virtual Reality EMDR (VR-EMDR) combines those
elements creating a treatment approach in which individuals intensify their
treatment by performing VR-EMDR in the home environment using VR technology.
There is currently no empirical evidence that supports the use of VR-EMDR in
PTSD patients.
Study objective
Feasibility is assessed after every VR-EMDR session and after treatment
completion. PTSD symptoms, quality of life and self-empowerment are assessed
before and after treatment.
Study design
Feasibility is assessed after every VR-EMDR session and after treatment
completion. PTSD symptoms, quality of life and self-empowerment are assessed
before and after treatment.
Intervention
Veterans get access to VR technology to do VR-EMDR treatment at home on top of
treatment as usual in addition to their regular, weekly EMDR treatment provided
by their therapist.
Study burden and risks
Veterans are receiving treatment for PTSD regardless of their participation in
the study. Extra burden associated with participation in this study is to carry
out VR-EMDR sessions at home. A possible risk is that the veteran experiences
state PTSD symptoms aggravation during the VR session when their therapist is
not readily available to assist. This risk is aimed to be reduced through a
safety protocol and the possibility of having the therapist available through a
video connection during the first VR-EMDR session. Benefits are that VR-EMDR
could improve self-efficacy and willingness to fully engage in trauma exposure,
thus improving PTSD symptoms. This is important because veterans show less
reduction in PTSD symptoms in trauma-focused treatment compared to other PTSD
populations, such as civilians
Bethaniestraat 10
's-Hertogenbosch 5211LJ
NL
Bethaniestraat 10
's-Hertogenbosch 5211LJ
NL
Listed location countries
Age
Inclusion criteria
Participants are eligible to participate if they:
Have a formal PTSD diagnosis;
Are veteran;
Are 18 years or older;
Have sufficient master of the Dutch language to perform assessments;
Are able to verbally express their traumatic memory;
Motivation to engage in a trauma-focused treatment
Exclusion criteria
Participants cannot take part in this trial if they:
Have an acute high risk for suicide;
Show acute, positive psychotic symptoms (for instance hallucinations or
delusions);
Suffer from severe impulse control issues or addiction which prevent them from
making safety agreements with their therapist;
Have an unsafe home environment or there is a lack of reliable information
regarding the home environment to assess the safety.
Design
Recruitment
Medical products/devices used
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 | NL80886.068.22 |