This study primarily aims to test the additional effect of walking during a Virtual Reality exposure treatment (3MDR) for patients with PTSD. Next, this study aims to investigate whether addressing trauma-related avoidance during 3MDR treatment is…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is PTSD severity over time, measured with
Clinical-Administered PTSD Scale for DSM-5 (CAPS-5).
Secondary outcome
Secondary outcome parameters are trauma-related avoidance and general avoidance
tendencies. Moreover, self-reported PTSD symptoms, depressive- and dissociative
symptoms, treatment expectancy and engagement, and heart and respiration rate
during VR exposure sessions will be measured.
Background summary
A new innovative Virtual Reality (VR) exposure treatment, 3MDR aims to improve
treatment outcome for patients with posttraumatic stress disorder (PTSD). This
trauma-focused treatment is delivered in a VR environment while patients walk
on a treadmill to trauma-related pictures, and aims to address avoidance during
treatment more effectively. Although previous randomised controlled trials
found 3MDR to be effective in veterans with
treatment-resistant PTSD, it is currently unknown if there is an added value of
walking on a treadmill during this treatment. Moreover, it remains unclear
whether preventing avoidance during treatment will indeed lead to enhanced PTSD
symptom reduction, as this is the hypothesized working mechanism of this novel
VR treatment.
Study objective
This study primarily aims to test the additional effect of walking during a
Virtual Reality exposure treatment (3MDR) for patients with PTSD. Next, this
study aims to investigate whether addressing trauma-related avoidance during
3MDR treatment is related to treatment outcome. Other objectives are to gain
insight into the association of both general avoidance tendencies and
trauma-related avoidance in relation to treatment outcome, and to test the
effectiveness of the 3MDR treatment in a general population of PTSD patients.
Study design
This study is a single blind randomized controlled trial in which PTSD patients
receive either VR exposure treatment or motion-assisted VR exposure treatment.
Assessments will be conducted at baseline (T0), before the start of the
treatment (T1), after the 6th VR exposure session (T2), after six additional VR
exposure sessions or six weeks post treatment (T3), and at 3-, 6-, 12- and
18-months follow-up.
Intervention
Participants in both VR exposure conditions receive at least 9 weekly treatment
sessions, including two preparatory treatment sessions, six VR exposure
sessions, and one concluding session. Based on residual symptom severity after
the first six VR exposure sessions, participants either continue with six
additional VR exposure sessions or complete treatment with a concluding
treatment session. Therefore, treatment duration will
be nine or fifteen weeks. The VR exposure treatment in both conditions use the
exact same treatment protocol, and only differ in whether the treatment is
delivered while the participant is walking or is in a stationary position.
Study burden and risks
All participants will receive an appropriate trauma-focused treatment which is
expected to be effective for patients with PTSD. Participants might experience
PTSD symptom exacerbation, and emotional discomfort during treatment. This is
inherent to receiving any trauma-focused treatment. For participants who
receive motion-assisted VR exposure treatment (3MDR), there is a risk of
falling on the treadmill, but many safety measures are in place to prevent them
from injuries (i.e., safety harness, safety handrails and emergency stops).
Besides the expected positive effect of this VR exposure treatment in reducing
PTSD symptoms, participants get the opportunity to choose for a different
treatment option (VR exposure) instead of traditional trauma-focused
treatments. Lastly, participants have to invest personal time for conducting
eight assessments, which is considered to be an acceptable burden given the
two-year study duration.
Altingerweg 1
Beilen 9411 PA
NL
Altingerweg 1
Beilen 9411 PA
NL
Listed location countries
Age
Inclusion criteria
1) PTSD diagnosis established by the Clinician-Administered PTSD scale for
DSM-5 (CAPS-5)
2) age 18 years or older
3) sufficient mastery of the Dutch language to perform the assessments
4) be able to keep a stable dose of psychotropic medication between four weeks
before entering the trial and until the first follow-up assessment, three
months post treatment (F4).
Exclusion criteria
1) unable to walk for approximately one hour
2) a high acute risk of suicidality
3) hospitalized in the past three months due to severe psychiatric conditions
(e.g., severe self-injury, acute florid psychotic symptoms or severe eating
disorder
4) report high levels of acute dissociative amnesia (memory gaps) which might
prevent them to store new, corrective information from the trauma-focused
treatment session
5) severe substance use disorder which needs specialized treatment
6) uses substances and cannot adhere to the agreement of not being under the
influence of addictive substances during treatment.
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 | NL83110.042.22 |