This study is aimed at assessing the effect of 3MDR treatment as compared to treatment as usual (TAU) on PTSD symptom severity in treatment resistant veterans with chronic cr-PTSD. It is expected that 3MDR will give a boosting effect to TAU…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the difference between the two groups in change in PTSD
symptom severity between start of the intervention and end of the study.
Secondary outcome
Other areas in which improvement is expected are perceived social support,
anxiety in general, depressive symptoms, avoidance of thoughts and behaviors,
and neuropsychological functioning (memory and attention).
Background summary
Several exposure-based therapies for treatment of Posttraumatic Stress Disorder
(PTSD) have been proven successful, in which (imaginal) exposure takes a
central role. Not all patients draw full benefit from these treatments, or drop
out from treatment, which is especially true for the population of veterans
with combat-related PTSD (cr-PTSD). For these patients the Multi-modular
Motion-assisted Memory Desensitization Reconsolidation (3MDR)-protocol may have
additional value. It incorporates elements from Virtual Reality Exposure
therapy (VREt) and Eye Movement Desensitization and Reprocessing (EMDR), while
adding a motion-based component. In this combination, veterans are challenged
to optimally approach their traumatic memories for exposure and working memory
is taxed more appropriately than with the standard EMDR procedure. The
expectation is that this approach will significantly decrease PTSD symptom
severity in comparison to a control group receiving treatment as usual
Study objective
This study is aimed at assessing the effect of 3MDR treatment as compared to
treatment as usual (TAU) on PTSD symptom severity in treatment resistant
veterans with chronic cr-PTSD. It is expected that 3MDR will give a boosting
effect to TAU following 3MDR. The study further assesses perceived social
support, anxiety in general, depressive symptoms, avoidance of thoughts and
behaviours, and neuropsychological functioning (memory and attention), aimed at
assessing changes in these domains.
Study design
This study is a randomized controlled trial (RCT) in a parallel design with one
experimental group (N=20) receiving 6 sessions of 3MDR and one control group
(N=20) who will receive TAU. Both groups will be followed-up after an
additional 6 and 10 weeks of TAU. Furthermore, patients in the intervention
group will be asked to participate in a qualitative interview on their
experiences with the 3MDR. This study will be performed at Stichting Centrum
*45 in Oestgeest or at GGZ Drenthe in Beilen.
Intervention
Participants will either receive six 3MDR treatment sessions followed by ten
weeks of TAU or will receive sixteen weeks of TAU, other than a trauma-focused
psychotherapy. TAU interventions may for instance include group therapy,
creative therapy or psychopharmacological therapy.
Study burden and risks
Subjects in the 3MDR group will receive six weekly 3MDR treatment sessions
instead of their treatment as usual. Before and after each sessions cortisol
will be measured in the saliva of participants to assess their stress response
during the session. Five assessments will take place which consist of
structured interviews, questionnaires and neuropsychological tests. None of the
procedures are invasive. The 3MDR-protocol includes elements from treatments as
Eye-Movement Desensitization and Reprocessing therapy and imaginal exposure
based treatments, to which most patients have been exposed before. Therefore it
is not likely that this therapy will be counterproductive and we consider the
burden of the study reasonable. In a proof of concept and first trial with a
total of 12 patients we noticed that those that received the 3MDR treatment did
well and improved on PTSD symptom severity and that lasting worsening of
symptoms did not occur.
Rijnzichtweg 35
Oegstgeest 2342 AX
NL
Rijnzichtweg 35
Oegstgeest 2342 AX
NL
Listed location countries
Age
Inclusion criteria
-Current chronic combat-related Posttraumatic Stress Disorder (Clinician Administered PTSD Scale (CAPS) score > 50, for at least 3 months).
- Being treatment resistant for trauma-focused psychotherapeutic interventions, which means having been treated for PTSD for a minimum of 6 consecutive months, of which 3 months with trauma-focused therapy, for instance Eye-Movement Desensitization Reprocessing (EMDR), Brief Eclectic Psychotherapy (BEP), Narrative Exposure Therapy (NET) or Prolonged Exposure (PE) with weekly sessions of at least 45 minutes or two-weekly session of at least 90 minutes.
Exclusion criteria
* Acute suicidality
* Difficulties walking, especially on a treadmill
* Current severe alcohol and/or substance dependence according to DSM-IV (patients are allowed to enter after initial treatment of this disorder).
* Acute psychosis.
* Patients must be stable on their current psychotropic medication for a period of 4 weeks before entering the trial and agree to not make changes in dosages or add any new medications during the course of the 3MDR treatment. In agreement with clinical guidelines patients were allowed to stop anxiolytic medication to better engage in trauma processing.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
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CCMO | NL51585.058.14 |