NCT01620866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

June 11, 2012

Last Update Submit

June 18, 2012

Conditions

Bipolar DisorderPTSD

Keywords

EMDRbipolar disordertraumasubsyndromal symptomsPTSD

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (5)

  • The EMDR group improves statistically significant in trauma load when compared to TAU.

    3 months and 6 months

  • The EMDR group improves statistically significant in cognitive tests when compared to TAU.

    3 months and 6 months

  • The EMDR group improves statistically significant in functioning when compared to TAU.

    3 months and 6 months

  • The EMDR group improves statistically significant in quality of life when compared to TAU.

    3 months and 6 months

  • Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU.

    3 months and 6 months

Study Arms (2)

EMDR

EXPERIMENTAL
Other: Eye Movement Desensitization Reprocessing (EMDR)

TAU

NO INTERVENTION

Treatment as usual (TAU)

Interventions

Eye Movement Desensitization Reprocessing (EMDR)OTHER

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

EMDR

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Major affective episode in last 3 months
  • Active drug abuse/dependency
  • Neurological disease
  • Suicidal thoughts/ideation
  • Prior treatment EMDR
  • DES \> 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FIDMAG

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (2)

  • 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.

    PMID: 17543031BACKGROUND

  • 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.

    PMID: 17636720BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderStress Disorders, Post-TraumaticWounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Benedikt L Amann, MD

    FIDMAG Germanes Hospitalàries

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 15, 2012

Study Start

November 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

ES(1)