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Completed

NCT Number: NCT01620866

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders PTSD Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FIDMAG

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eye Movement Desensitization Reprocessing (EMDR)

Other

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

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.

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

FIDMAG Germanes Hospitalàries

Other

Registry information

Official study title

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

Acronym: BET

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2012
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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