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

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ClinicalTrials.gov Identifier: NCT01620866
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Benedikt Amann, 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620866


Locations
Spain
FIDMAG
Barcelona, Spain, 08035
Sponsors and Collaborators
FIDMAG Germanes Hospitalàries
Investigators
Principal Investigator: Benedikt L Amann, MD FIDMAG Germanes Hospitalàries

Publications:
Responsible Party: Benedikt Amann, Senior researcher, FIDMAG Germanes Hospitalàries
ClinicalTrials.gov Identifier: NCT01620866     History of Changes
Other Study ID Numbers: BET-study
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Benedikt Amann, FIDMAG Germanes Hospitalàries:
EMDR
bipolar disorder
trauma
subsyndromal symptoms
PTSD

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders