Condition category
Mental and Behavioural Disorders
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes