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

Primary Purpose

Bipolar Disorder, PTSD

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Eye Movement Desensitization Reprocessing (EMDR)
Sponsored by
FIDMAG Germanes Hospitalàries
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FIDMAG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EMDR

TAU

Arm Description

Treatment as usual (TAU)

Outcomes

Primary Outcome Measures

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.
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

The EMDR group improves statistically significant in trauma load when compared to TAU.
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.
Subjects underwent a neuropsychologcial battery to test various cognitive domains.
The EMDR group improves statistically significant in functioning when compared to TAU.
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.
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.
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.

Full Information

First Posted
June 11, 2012
Last Updated
June 18, 2012
Sponsor
FIDMAG Germanes Hospitalàries
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1. Study Identification

Unique Protocol Identification Number
NCT01620866
Brief Title
A Eye Movement Desensitization Reprocessing (EMDR) Study in Bipolar Traumatized Patients
Acronym
BET
Official Title
A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
FIDMAG Germanes Hospitalàries

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, PTSD
Keywords
EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMDR
Arm Type
Experimental
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual (TAU)
Intervention Type
Other
Intervention Name(s)
Eye Movement Desensitization Reprocessing (EMDR)
Intervention Description
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
The EMDR group improves statistically significant in trauma load when compared to TAU.
Description
Secondary outcome measure includes changes in trauma scales (IES, CAPS)from baseline to 3 months and 6 months.
Time Frame
3 months and 6 months
Title
The EMDR group improves statistically significant in cognitive tests when compared to TAU.
Description
Subjects underwent a neuropsychologcial battery to test various cognitive domains.
Time Frame
3 months and 6 months
Title
The EMDR group improves statistically significant in functioning when compared to TAU.
Description
All subjects were evaluated with respect to their functioning using the FAST, a validated scale of functioning in bipolar disorder.
Time Frame
3 months and 6 months
Title
The EMDR group improves statistically significant in quality of life when compared to TAU.
Description
Possible changes of Quality of life were tested in all subjects as well, using the SF-36.
Time Frame
3 months and 6 months
Title
Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.
Description
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.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedikt L Amann, MD
Organizational Affiliation
FIDMAG Germanes Hospitalàries
Official's Role
Principal Investigator
Facility Information:
Facility Name
FIDMAG
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17543031
Citation
Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x.
Results Reference
background
PubMed Identifier
17636720
Citation
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3.
Results Reference
background

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

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