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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 11, 2012
First Posted Date  ICMJE June 15, 2012
Last Update Posted Date June 19, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2012)
The EMDR group improves statistically significant trauma load, cognition, functioning, quality of life and increases BDNF levels when compared to the TAU group. [ Time Frame: 3 months and 6 months ]
Secondary outcome measures include changes in trauma scales (IES, CAPS), a serie of neuropsychological tests(like TAP, WAIS, WMS, Stroop, Rivermead, BADS), the FAST (a scale for functioning in bipolar disorder), quality of life (SF-36) from baseline to 3 months and 6 months. BDNF levels will be measured before intervention and at visit 6 months; the hypothesis is that BDNF levels in the EMDR group will be statistically significant higher than in the TAU group.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
Official Title  ICMJE A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • PTSD
Intervention  ICMJE Other: Eye Movement Desensitization Reprocessing (EMDR)
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
Study Arms  ICMJE
  • Experimental: EMDR
    Intervention: Other: Eye Movement Desensitization Reprocessing (EMDR)
  • No Intervention: TAU
    Treatment as usual (TAU)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2012)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01620866
Other Study ID Numbers  ICMJE BET-study
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benedikt Amann, FIDMAG Germanes Hospitalàries
Study Sponsor  ICMJE FIDMAG Germanes Hospitalàries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benedikt L Amann, MD FIDMAG Germanes Hospitalàries
PRS Account FIDMAG Germanes Hospitalàries
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP