The effect of EMDR therapy in patients with bipolar disorder and a history of traumatic events: a randomized controlled trial.
- Conditions
- bipolar disordermanic depressive illness10026753
- Registration Number
- NL-OMON46084
- Lead Sponsor
- Altrecht GGZ (Den Dolder)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
- * 18 years of age
- A primary diagnosis of DSM-5 bipolar I or II disorder
- A history of (a) traumatic event(s) that is still causing clinically relevant distress
- Organic brain disorder
- Mental retardation
- Dependency of drugs and/or alcohol
- Severe suicidality or psychosis in the last month
- Moderate to severe depressive or hypomanic symptoms at the start of the intervention (CGI-BP mania > 4, CGI-BP depression > 5).
- Patients are currently in some other form of psychological treatment for trauma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is a significant decrease in affective symptoms<br /><br>measured by daily mood reports with the National Institute of Mental Health<br /><br>Life Chart Methodology (NIMH LCM), Altman Selfrating Mania Scale-NL (ASRM-NL)<br /><br>and/or the Inventory of Depressive Symptoms-Self Report (IDS-SR). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameter is a significant reduction of trauma symptoms<br /><br>measured by the Clinician Administered PTSD Scale (CAPS) and the PTSD Checklist<br /><br>for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5).<br /><br><br /><br>Another study parameter is that EMDR does not lead to mood episodes or an<br /><br>increase of mood symptoms. </p><br>