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ID
Source
Brief title
Health condition
Post traumatic stress disorder
Post traumatische stress stoornis
Sponsors and support
Vereniging EMDR Nederland
Arq Psychotrauma Expert Groep
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is the difference in PTSD symptom severity response pattern during the five sessions between the EMDR + EMD app-group as compared to the group that receives EMDR alone and will be measured with the PCL-5 Questionnaire.
Secondary outcome
Secondary outcomes include depressive symptoms (HADS), general anxiety symptoms (HADS), quality of life (SF-12), acceptability (CSQ-8), usability (SUS) and client satisfaction.
Background summary
Posttraumatic stress disorder (PTSD) is a mental health problem with a high prevalence in the general population. Still 30% of patients do not benefit sufficiently from existing interventions. There is a need to increase the efficiency and efficacy of treatments for PTSD. The primary objective of the current study is to investigate a potential increase in efficiency of standard trauma treatment for outpatients with PTSD by adding a digital device that closely follows the principles of manualized EMDR treatment, the EMD app.
This is a two arm pilot randomized controlled trial with a pre-post design, in which patients will be randomized to receive EMDR treatment with addition of the EMD app (five weeks unlimited access to the EMD app) or EMDR treatment alone (no access to the EMD app). Measurements will take place at baseline and at each of the five weekly EMDR sessions. A post-measurement takes place in the sixth week; after five EMDR sessions.
We will recruit N = 60 adult outpatients with a current PTSD diagnosis due to a work-related traumatic incident who are referred by their company doctor to the Institute for Psychotrauma (IVP), part of Arq Psychotrauma Expert Group.
The EMD app is a digital application that can be used on smartphone, laptop and computer at home as an additive therapeutic intervention to an outpatient EMDR treatment. The application closely follows the main steps of the EMDR treatment, which is one of the most effective interventions for PTSD.
The primary outcome parameter is the difference in PTSD symptom severity response pattern during the five sessions between the EMDR + EMD app group as compared to the EMDR alone group. Secondary outcomes include depressive symptoms, general anxiety symptoms, acceptability, usability and client satisfaction.
Update:
After recruiting 33 patients, we updated in March 2019 the EMD app 1.0 and started providing our patients since then with the new 2.0 version. The 2.0 version is identical to the 1.0 version but entails instead of one, it includes three digital games with the intend to tax working memory in patients according to the EMDR protocol. In addition, the EMD-app 2.0 was made accessible as a mobile app via the IOS and Android store as compared to being a web-app only.
The stop date was updated due to recruitment challenges and is the 30-06-2020.
Study objective
The hypothesis is that by addition of the EMD- app the regular treatment effect of EMDR will be reached within fewer treatment sessions, because patients will actively apply therapeutic techniques at home, similar to the techniques that are provided in their treatment sessions.
Study design
The primary outcome is assessed at seven time points:
1. Before treatment (baseline)
2. A measurement at the start of the first five EMDR-sessions
3. Posttreatment after five sessions
Secondary outcomes are assessed pre- and post-treatment.
Intervention
The EMD-app is a digital application that can be used on smartphone, laptop and computer at home as an additive intervention to an EMDR treatment. The application closely follows the main steps of the EMDR treatment.
The user of the EMD-APP will receive the instruction to keep in mind the most disturbing image from a traumatic recollection. The intervention consist of a simple “game” in which a participant must match abstract figures as quickly als possible. This serves as a distracting stimulus to tax the working memory sufficiently.
In the intervention group patients receive an EMDR treatment with addition of the EMD app. They have to use the EMD-APP in between of the first six EMDR-sessions of their treatment.
Patients in the control group receive an EMDR-treatment as usual.
N. Boumparis
Rijnzichtweg 35
Oegstgeest 2342 AX
The Netherlands
+31205982700
n.boumparis@amsterdamumc.nl
N. Boumparis
Rijnzichtweg 35
Oegstgeest 2342 AX
The Netherlands
+31205982700
n.boumparis@amsterdamumc.nl
Inclusion criteria
- 18 – 65 years of age
- Referred to the Institute for Psychotrauma (IVP), part of Arq Psychotrauma Expert Group, for PTSD following one or more work-related traumatic experiences.
- Meet the DSM-5 diagnostic criteria for PTSD as confirmed by the CAPS-5
- In possession of a device such as a laptop, tablet, mobile phone or computer.
- Have sufficient command of the Dutch language, both verbally and in writing.
- Provide signed informed consent
Exclusion criteria
- Having current high risk for suicide according to the M.I.N.I. Interview section C
- Having serious psychiatric co-morbidity i.e. bipolar affective disorder, psychotic illness, substance dependence that would interfere with EMDR treatment as assessed by the therapist in the intake
-Being unable to comprehend the spoken and written Dutch language
-Not having access to a computer, laptop, tablet or smartphone with an internet connection
Design
Recruitment
IPD sharing statement
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 | NL5643 |
| NTR-old | NTR5758 |
| CCMO | NL53877.018.15 |
| OMON | NL-OMON47137 |