A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- FIDMAG Germanes Hospitalàries
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this pilot study is whether Eye Movement Desensitization Reprocessing (EMDR), an approved psychotherapy in posttraumatic stress disorder, improves mood, functioning, quality of life, cognition and BDNF levels in subsyndromal bipolar patients with trauma.
Investigators
Benedikt Amann
Senior researcher
FIDMAG Germanes Hospitalàries
Eligibility Criteria
Inclusion Criteria
- •Bipolar I or II disorder following DSM-IV criteria
- •Instable, subsyndromal course defined as at evaluation baseline (HAMD \> 8 \< 15 and/or YMRS \> 7 \< 14)
- •Good adherence to pharmacological treatment
- •Major or minor traumatic life-events
- •EMDR therapists \> 3 years experience
- •Able to sign informed consent
Exclusion Criteria
- •Major affective episode in last 3 months
- •Active drug abuse/dependency
- •Neurological disease
- •Suicidal thoughts/ideation
- •Prior treatment EMDR
- •DES \> 25
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The EMDR group improves statistically significant in trauma load when compared to TAU.(3 months and 6 months)
- The EMDR group improves statistically significant in cognitive tests when compared to TAU.(3 months and 6 months)
- The EMDR group improves statistically significant in functioning when compared to TAU.(3 months and 6 months)
- The EMDR group improves statistically significant in quality of life when compared to TAU.(3 months and 6 months)
- Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.(3 months and 6 months)