A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients

Not Applicable

Completed

• Conditions: Bipolar Disorder; PTSD
• Interventions: Other: Eye Movement Desensitization Reprocessing (EMDR)

• Registration Number: NCT01620866
• Lead Sponsor: FIDMAG Germanes Hospitalàries

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Last Update Submitted: 2012-06-18
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMDR	Eye Movement Desensitization Reprocessing (EMDR)	-

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
The EMDR group improves statistically significant in trauma load when compared to TAU.	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.	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.	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.	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.	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.

Trial Locations

Locations (1)

FIDMAG; 🇪🇸 Barcelona, Spain