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

Bipolar Disorder Clinical Trial

— BET  

Official title:

A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620866
• Other study ID #: BET-study
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: June 18, 2012
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: FIDMAG Germanes Hospitalàries
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• PTSD

Intervention

Other:
• Eye Movement Desensitization Reprocessing (EMDR)
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.

Locations

Country	Name	City	State
Spain	FIDMAG	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
FIDMAG Germanes Hospitalàries

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. Review. Update in: Cochrane Database Syst Rev. 2013;12:CD003388. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	3 months and 6 months	No
Secondary	The EMDR group improves statistically significant in cognitive tests when compared to TAU.	Subjects underwent a neuropsychologcial battery to test various cognitive domains.	3 months and 6 months	No
Secondary	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.	3 months and 6 months	No
Secondary	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.	3 months and 6 months	No
Secondary	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.	3 months and 6 months	No