|- candidate number||10514|
|- NTR Number||NTR3134|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-nov-2011|
|- Secondary IDs|| |
|- Public Title||EMDR versus CBT in treatment of panic disorders with or without agoraphobia: a Randomized Controlled Trial.|
|- Scientific Title||EMDR versus CBT in treatment of panic disorders with or without agoraphobia: a Randomized Controlled Trial.|
|- ACRONYM||EMDR vs. CBT in the treatment of panic disorders: A RCT|
|- hypothesis||1. The first hypothesis is that treatment of panic disorders with or without agoraphobia with EMDR as well as with CBT will lead to symptom reduction. This symptom reduction is expected to be larger in the EMDR treatment group than in the CBT treatment group, when a patient still suffers from traumatic memories in the present;|
2. The second hypothesis is that treatment of panic disorders with or without agoraphobia with EMDR as well as with CBT will lead to an increase of quality of life. This increase of quality of life is expected to be larger in the EMDR treatment group than in the CBT treatment group, when a patient still suffers from traumatic memories in the present.
|- Healt Condition(s) or Problem(s) studied||Panic disorder, Agoraphobia|
|- Inclusion criteria||1. Primary diagnosis of panic disorder with or without agoraphobia according to the DSM-IV-TR;|
2. Age between 18 and 65 years;
3. Sufficient knowledge of the Dutch language.
|- Exclusion criteria||1. Dementia;|
3. Severe depression;
4. Bipolar disorder;
5. Personality disorder;
6. Substance dependence (>20 units of alcohol per week);
7. Use of benzodiazepines or other sedative agents;
8. Use of anti-depressants.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2010|
|- planned closingdate||31-aug-2012|
|- Target number of participants||68|
|- Interventions||Two forms of psychotherapy will be compared: Eye Movement Desensitization Reprocessing (EMDR) and Cognitive Behavioral Therapy (CBT). Patients are randomly assigned to one of the two treatment conditions. In both groups, there is one treatment session of 45 to 60 minutes per week for thirteen consecutive weeks. All interventions will be delivered by qualified therapists. |
|- Primary outcome||1. Symptoms of a panic disorder with or without agoraphobia (SCID-I);|
2. Quality of life (WHOQOL-Bref).
|- Secondary outcome||1. Severity of panic disorder (ACQ; BSQ);|
2. Severity of agoraphobia (MI);
3. Number of panic attacks (registration form).
|- Timepoints||1. Baseline measurement: Before treatment;|
2. Second measurement: After treatment;
3. third measurement: Three months after completion of treatment;
4. Fourth measurement: One year after third measurement.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Ferdinand Horst|
|- CONTACT for SCIENTIFIC QUERIES|| Ferdinand Horst|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|- Brief summary||Several studies have shown that CBT is an effective treatment method to patients with a panic disorder with or without agoraphobia. Nevertheless, there is a group of patients who need additional treatment after CBT, especially after a long follow-up period. EMDR has already been proved to be an effective treatment method to patients with PTSD and trauma’s. Nevertheless, the effectiveness of EMDR in treatment of a panic disorder with or without agoraphobia is still unclear, while there are several reasons why EMDR could be an effective treatment method to this patient group. A first panic attack is traumatizing to many patients, because it occurs suddenly, it can seem life threatening and patients feel like they lose control. A first panic attack may cause a conditioned fear to a next panic attack. This will be the first study to compare EMDR with CBT in the treatment of panic disorders with or without agoraphobia. |
|- Main changes (audit trail)|
|- RECORD||8-nov-2011 - 21-nov-2011|