|- candidate number||24010|
|- NTR Number||NTR5758|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-feb-2016|
|- Secondary IDs||NL53877.018.15 Toetsingonline|
|- Public Title||Addition of the EMD app in PTSD treatment|
|- Scientific Title||Investigating a digital device to increase the efficiency of trauma-focused psychotherapy in PTSD patients: a pilot randomized controlled trial of the EMD app|
|- ACRONYM||EMD-APP for PTSD |
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Post traumatic stress disorder|
|- 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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||23-feb-2016|
|- planned closingdate||23-feb-2017|
|- Target number of participants||60|
|- Interventions||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.
|- 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.|
|- Timepoints||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.
|- Trial web site||not applicable|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc M. van Buuren|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Olff|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Department of Psychiatry|
(Source(s) of Monetary or Material Support)
|Kansen voor West, Vereniging EMDR Nederland (VEN), Arq Psychotrauma Expert Groep|
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||26-feb-2016 - 22-mei-2016|