|- candidate number||0|
|- NTR Number||NTR46|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||28-jun-2005|
|- Secondary IDs||N/A |
|- Public Title||Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy versus Brief Eclectic Psychotherapy (BEP) in the treatment of posttraumatic stress disorder.|
|- Scientific Title||Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy versus Brief Eclectic Psychotherapy (BEP) in the treatment of posttraumatic stress disorder.|
|- hypothesis||In line with a previous pilot study, we hypothesize that EMDR will lead to faster improvements in PTSD symptomatology than BEP and that the effects at the end will be equal.|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD)|
|- Inclusion criteria||1. Fulfilling diagnostic criteria for PTSD according to the DSM-IV;|
2. Having experienced a single traumatic event that was the cause for developing PTSD;
3. Age between 18 and 65 years;
4. Mastery of the Dutch language in speech and writing.
|- Exclusion criteria||1. Suicidal ideation;|
2. Current severe comorbid disorders that would interfere with the intervention (severe major depressive disorder, severe alcohol or substance dependance);
3. A lifetime psychotic disorder;
4. Indications of fulfilling diagnostic criteria for a personality disorder according to the SCID-II screener and clinical opinion.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2003|
|- planned closingdate||1-jan-2011|
|- Target number of participants||140|
|- Interventions||Eye Movement Desensitization and Reprocessing (EMDR) is a combination of trauma exposure (desensitization) with saccadic eye movements. When anxiety diminishes, the patient is instructed to develop more positive cognitions and link these to the trauma. |
Brief Eclectic Psychotherapy (BEP) is primarily a cognitive behavioral intervention, but ‘eclectic’ means that elements of psychodynamic and directive psychotherapy are also part of this therapy.
|- Primary outcome||Self-reported PTSD symptoms (Impact of Event Scale –Revised; IES-R).|
|- Secondary outcome||Secondary outcomes are clinician-rated PTSD (SI-PTSD), anxiety and depression symptoms (HADS), comorbid psychopathology (SCID-I), quality of life (SF-36), long term costs of illness (TiC-P), posttraumatic cognitions (PTCI), posttraumatic growth (PGI). Tertiary outcomes are the effects of both treatments on neuropsychological functioning (verbal memory and attention) and neuroendocrine parameters of PTSD such as cortisol.|
|- Timepoints||Patients are assessed at four time points: |
1. Before treatment;
2. First post-assessment after the EMDR therapy and the first phase of BEP;
3. Second post-assessment after both treatments are finished;
4. Follow-up assessment 12 months after the second post-assessment.
1-feb-2009: Patient inclusion closed;
Anticipated date of last follow-up 1-dec-2010;
Planned closure to data entry 1-jan-2011;
Date trial data considered complete 1-jan-2011.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc. M.J. Nijdam|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Olff|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Though the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy and cognitive behavioral approaches for PTSD have been sufficiently demonstrated, few studies have compared them directly. The current study aims at studying the effectiveness of EMDR and Brief Eclectic Psychotherapy (BEP) to determine if these treatments work in clinical practice.
Research objectives are:
1. To compare the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy and Brief Eclectic Psychotherapy (BEP) in the treatment of patients with posttraumatic stress disorder;
2. To determine the effectiveness of the treatments at long-term follow up;
3. To determine the effects of the treatments on neuropsychological functioning;
4. To determine the effects of the treatments on neuroendocrine parameters in a subgroup of patients;
5. To determine which patients benefit most from EMDR or BEP.
|- Main changes (audit trail)|
|- RECORD||14-jul-2005 - 5-mrt-2010|