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

June 18, 2012 updated by: Benedikt Amann, FIDMAG Germanes Hospitalàries

A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • FIDMAG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
3 months and 6 months
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.
3 months and 6 months
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.
3 months and 6 months
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.
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FIDMAG Germanes Hospitalàries

Investigators

  • Principal Investigator: Benedikt L Amann, MD, FIDMAG Germanes Hospitalàries

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

June 19, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BET-study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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