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

NCT ID: NCT01620866

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Bipolar Disorder PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EMDR

Group Type EXPERIMENTAL

Eye Movement Desensitization Reprocessing (EMDR)

Intervention Type OTHER

EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.

TAU

Treatment as usual (TAU)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eye Movement Desensitization Reprocessing (EMDR)

EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FIDMAG Germanes Hospitalàries

OTHER

Sponsor Role lead

Responsible Party

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Benedikt Amann

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benedikt L Amann, MD

Role: PRINCIPAL_INVESTIGATOR

FIDMAG Germanes Hospitalàries

Locations

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FIDMAG

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 17543031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17636720 (View on PubMed)

Other Identifiers

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BET-study

Identifier Type: -

Identifier Source: org_study_id

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