Efficacy and efficiency of Eye Movement Desensitisation and Reprocessing therapy versus Brief Eclectic Psychotherapy (BEP) in the treatment of post-traumatic stress disorder
| ISRCTN | ISRCTN64872147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64872147 |
| Secondary identifying numbers | NTR46 |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 04/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M Olff
Scientific
Scientific
Academic Medical Center (AMC)
Department of Psychiatry
Meibergdreef 5
PA1-192
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 891 3662 |
|---|---|
| m.olff@amc.uva.nl |
Study information
| Study design | Randomised-controlled parallel-group single-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | BEP-EMDR |
| Study objectives | 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(s) | Ethics approval received from the local ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2003 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Key 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. |
| Key exclusion criteria | 1. Severe comorbidity that would interfere with treatment 2. Enhanced risk for suicide and psychotic disorders |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
University/education
University/education
Emma Kinderziekenhuis
P.O.Box 22660
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academisch Medisch Centrum
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No |
