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ID
Source
Brief title
Health condition
Posttraumatische Stressstoornis
Posttraumatic Stress Disorder
Sponsors and support
Arq Psychotrauma Expert Groep
GGZ Drenthe
Intervention
Outcome measures
Primary outcome
The primary clinical outcome parameter is the difference in PTSD symptom severity measured prior to, during and after treatment. Furthermore, cost-effectiveness will be assessed through health-related quality of life and social costs.
Secondary outcome
Our secondary outcomes include: avoidance behaviour, PTSD severity rated by a spouse, anxiety and depressive symptoms, impairment in daily functioning due to PTSD symptoms, neuropsychological functioning, and for the 3MDR condition physiological responses during sessions.
Background summary
Uit eerder onderzoek blijkt dat een deel van de patiënten met een posttraumatische stressstoornis (PTSS) onvoldoende profiteert van het huidige evidence-based behandelaanbod. Een mogelijke verklaring voor deze stagnatie is vermijding, zowel cognitief als emotioneel. Om deze vermijding te doorbreken is bij het Militair Revalidatie Centrum in Doorn de basis gelegd voor een revolutionaire psychotherapie. 3MDR staat voor Multi-modular Motion-assisted Memory Desensitisation and Reprocessing en maakt gebruik van de elementen beweging, virtual reality, muziek en foto’s ter ondersteuning van de exposure.
Het huidige onderzoek is een randomised controlled trial (RCT) gericht op het vergelijken van de 3MDR behandeling met de meer conventionele evidence-based behandelingen: traumagerichte CGT, EMDR, BEPP en NET, waarbij we kijken naar de klinische- en kosteneffectiviteit. Hiervoor nodigen wij patiënten uit die vanwege hun werk een PTSS hebben opgelopen en nog niet eerder traumagerichte behandeling hebben ontvangen.
Het onderzoek wordt uitgevoerd bij Stichting Centrum '45 in Oegstgeest en bij de GGZ Drenthe, locatie Beilen.
Study objective
We hypothesize that 3MDR is superior in clinical and cost-effectiveness compared to care as usual.
Study design
This study is set up as a single blind parallel group randomized controlled trial in which patients will be randomized to receive 3MDR treatment (10 weekly sessions) or CAU (16 weekly sessions of TF-PT). Both groups will undergo six assessments which will take place at baseline, at eight weeks, at 11 weeks for the control condition, at 17 weeks for the experimental condition, directly after treatment, and with a 12 week interval twice for follow-up.
Intervention
This study entails two treatment conditions: the experimental 3MDR intervention and conventional TF-PT. The 3MDR intervention is a new type of high intensive exposure treatment, which combines elements of virtual reality exposure therapy (VRET), eye movement desensitisation and reprocessing (EMDR), physical activity and music. During a 3MDR session patients are continuously walking on the treadmill. The protocollized sessions start with music that facilitates reminders of the traumatic period, followed by walking on a virtual path towards prior selected pictures that are highly affect laden. After narrating each picture and labeling current emotions and physical sensations a second neurocognitive task is presented in the form of a oscilating ball with numbers that need to be read. This task is taxing working memory, and is aimed as distractor from the highly affective memories recalled just before. After seven pictures the session finishes by walking back on the path to current time accompanied by contemporary music that facilitates reorientation into the present. The CAU condition can consist of one of four selected evidence-based psychotherapies: trauma-focused cognitive behavioural therapy (TF-CBT), EMDR, narrative exposure therapy (NET) or brief eclectic psychotherapy for PTSD (BEPP).
Rijnzichtweg 35
Oegstgeest 2342 AX
The Netherlands
+31 (0)6 51 45 6771
k.schols@centrum45.nl
Rijnzichtweg 35
Oegstgeest 2342 AX
The Netherlands
+31 (0)6 51 45 6771
k.schols@centrum45.nl
Inclusion criteria
Work-related PTSD
Naive to trauma treatment or never finished a trauma treatment protocol
18 years and older
Exclusion criteria
Acute psychotic symptoms
Acute substance use disorder
Acute suicidality
Inability to walk
Inability to understand and speak Dutch
No medication or medication should be a consistent dosage for 4 weeks prior to the trial and be held consistent during the entire trail.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6837 |
NTR-old | NTR7074 |
CCMO | NL60406.058.17 |
OMON | NL-OMON55588 |