Contact information
Type
Scientific
Primary contact
Dr M Olff
ORCID ID
Contact details
Academic Medical Center (AMC)
Department of Psychiatry
Meibergdreef 5
PA1-192
Amsterdam
1105 AZ
Netherlands
+31 (0)20 891 3662
m.olff@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR46
Study information
Scientific title
Efficacy and efficiency of Eye Movement Desensitisation and Reprocessing therapy versus Brief Eclectic Psychotherapy (BEP) in the treatment of post-traumatic stress disorder
Acronym
BEP-EMDR
Study hypothesis
Eye movement desensitisation and reprocessing (EMDR) therapy is applied frequently in clinical practice as a treatment method for psychological trauma. Arguments for applying EMDR are faster symptom reduction, lower dropout and better tolerance than cognitive behavioural interventions. However, in the Netherlands a randomised controlled study determining efficacy and efficiency of EMDR has not yet been performed.
Research objectives:
1. To compare efficacy of EMDR therapy and brief eclectic psychotherapy (BEP) in the treatment of patients with post-traumatic stress disorder
2. To test whether EMDR is more efficient than BEP
3. To determine efficacy of the treatments at long-term follow up
4. To determine which patients benefit most from EMDR or BEP
5. To determine the effects of both treatments on comorbid psychopathology, like major depressive disorder
The overall trial end date was changed from 01/12/2006 to 01/12/2007.
On 14/02/2012 the following changes were made to the trial record:
1. The target number of participants was changed from 120 to 140.
2. The overall trial end date was changed from 01/12/2007 to 01/02/2009.
Ethics approval
Ethics approval received from the local ethics committee
Study design
Randomised-controlled parallel-group single-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Mental disorders, post-traumatic stress disorder
Intervention
EMDR is a combination of trauma exposure (desensitisation) with saccadic eye movements. When anxiety diminishes, the patient is instructed to develop more positive cognitions and link these to the trauma.
BEP is primarily a cognitive behavioral intervention, but 'eclectic' means that elements of psychodynamic and directive psychotherapy are also part of this therapy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Impact of Event Scale - Revised (IES-R)
2. Hospital Anxiety and Depression Scale (HADS)
Secondary outcome measures
Structured clinical interviews are administered, as well as neuropsychological tests and other self-report measures.
Overall trial start date
01/12/2003
Overall trial end date
01/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 14/02/2012
One hundred and forty patients with post-traumatic stress disorder for at least one month after the traumatic experience according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, will be included. They are asked to participate after intake at the Outpatient Psychiatry Clinic of the Academic Medical Center/De Meren.
Previous inclusion criteria
One hundred and twenty patients with post-traumatic stress disorder for at least one month after the traumatic experience according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, will be included. They are asked to participate after intake at the Outpatient Psychiatry Clinic of the Academic Medical Center/De Meren.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Severe comorbidity that would interfere with treatment
2. Enhanced risk for suicide and psychotic disorders
Recruitment start date
01/12/2003
Recruitment end date
01/02/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Emma Kinderziekenhuis
P.O.Box 22660
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academisch Medisch Centrum
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22322458
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26335088
Publication citations
-
Results
Nijdam MJ, Gersons BP, Reitsma JB, de Jongh A, Olff M, Brief eclectic psychotherapy v. eye movement desensitisation and reprocessing therapy for post-traumatic stress disorder: randomised controlled trial., Br J Psychiatry, 2012, 200, 3, 224-231, doi: 10.1192/bjp.bp.111.099234.
-
Results
Nijdam MJ, de Vries GJ, Gersons BP, Olff M, Response to psychotherapy for posttraumatic stress disorder: the role of pretreatment verbal memory performance, J Clin Psychiatry, 2015, 76, 8, e1023-e1028.