The primary objective is to study the effectiveness of EMDR in comparison to PE for treating military personnel and veterans with psychological trauma. Secondary objectives are:1. to investigate if working memory capacity is a predictor of EMDR…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measure is the change in psychological trauma symptoms from
before to after the treatment, measured by a self-report questionnaire and a
clinical interview.
Secondary outcome
For the secondary outcomes, we will test performance on a (working) memory
task. Task performance will be investigated as potential predictor of
treatment succes.
Background summary
Posttraumatic stress disorder (PTSD) and 'Other Specified Trauma- and
Stressor-Related Disorder' are mental disorders that can occur following a
traumatic event. Psychological trauma in military personnel may differ from
civilian psychological trauma for example due to the nature of the trauma, or
extensive military training. Eye movement desensitisation and reprocessing
(EMDR) and prolonged exposure (PE) are trauma-focused therapies that have been
shown to be effective at reducing trauma symptoms in civilians. PE has also
been shown to be effective at treating military personnel with trauma. In
contrast, the effectiveness of EMDR for military personnel and veterans is
currently under debate, because a recent meta-analysis showed that it might not
be effective in this population. Despite this, EMDR is often used at military
mental health services to treat psychological trauma. In conclusion, there is a
need to investigate the effectiveness of EMDR for treating military personnel
and veterans with psychological trauma. Furthermore, the mechanism underlying
EMDR is unknown. Gaining mechanistic insight into EMDR neuropsychology could
contribute to identifying predictors for treatment success.
Study objective
The primary objective is to study the effectiveness of EMDR in comparison to PE
for treating military personnel and veterans with psychological trauma.
Secondary objectives are:
1. to investigate if working memory capacity is a predictor of EMDR treatment
success
Study design
The proposed study is a single-blind randomised controlled between-subjects
non-inferiority trial.
Intervention
Patients will be randomly assigned to EMDR or PE. Both therapies are validated
trauma-focused therapies that are recommended by the Dutch guidelines for the
treatment of psychological trauma. Patients will receive 10 90-minute treatment
sessions during a period of 12 weeks.
Study burden and risks
Patients will receive standard treatment for psychological trauma. Increased
stress or emotional discomfort might occur due to exposure to a psychological
trauma. However, this is the case for all trauma-focused therapies and
therefore we consider this risk acceptable. Following each session, patients
will fill in a brief questionnaire. Besides the therapy sessions, patients will
complete four main assessments. The first assessment takes about 3 hours, the
second 90 minutes, and the third and fourth one take 20 minutes. We consider
this an acceptable burden since these assessments are spread out over a period
of several months: one before treatment, one immediately following treatment,
after 26 and 52 weeks.
Lundlaan 1
Utrecht 3584EZ
NL
Lundlaan 1
Utrecht 3584EZ
NL
Listed location countries
Age
Inclusion criteria
- Military personnel of the Dutch Defence organisation or veterans who served
for the Kingdom of the Netherlands
- PTSD or 'other specified trauma and stressor-related disorder' diagnosis by
therapist.
- Master the Dutch language
- Assigned to a PTSD psychotherapy treatment
- Aged 18-64 year
Exclusion criteria
-
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 | NL81607.041.22 |