A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients (BET)
|ClinicalTrials.gov Identifier: NCT01620866|
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : June 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder PTSD||Other: Eye Movement Desensitization Reprocessing (EMDR)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Other: Eye Movement Desensitization Reprocessing (EMDR)
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
No Intervention: TAU
Treatment as usual (TAU)
- The primary outcome of this study is a statistically significant reduction in the YMRS and/or HDRS in the EMDR group compared with the TAU group. [ Time Frame: 3 months and 6 months ]Patients with subsydromal symptoms, objectified by the YMRS and HDRS, are included in the study. After randomization to EMDR or TAU, group differences in changes in the YMRS and HRDS are measured at visit after intervention (3 months) and at follow-up (6 months). The hypothesize is that the EMDR group will statistically improve in both affective scales when compared to the TAU group.
- The EMDR group improves statistically significant in trauma load when compared to TAU. [ Time Frame: 3 months and 6 months ]Secondary outcome measure includes changes in trauma scales (IES, CAPS)from baseline to 3 months and 6 months.
- The EMDR group improves statistically significant in cognitive tests when compared to TAU. [ Time Frame: 3 months and 6 months ]Subjects underwent a neuropsychologcial battery to test various cognitive domains.
- The EMDR group improves statistically significant in functioning when compared to TAU. [ Time Frame: 3 months and 6 months ]All subjects were evaluated with respect to their functioning using the FAST, a validated scale of functioning in bipolar disorder.
- The EMDR group improves statistically significant in quality of life when compared to TAU. [ Time Frame: 3 months and 6 months ]Possible changes of Quality of life were tested in all subjects as well, using the SF-36.
- Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU. [ Time Frame: 3 months and 6 months ]Levels of BDNF are lower in bipolar patients, and even lower when traumatized, when compared to the general population. We aimed to find higher levels of BDNF in the EMDR group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620866
|Barcelona, Spain, 08035|
|Principal Investigator:||Benedikt L Amann, MD||FIDMAG Germanes Hospitalàries|