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

Study Overview
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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.

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

Conditions
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Bipolar Disorder, PTSD

Intervention / Treatment
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* Other: Eye Movement Desensitization Reprocessing (EMDR)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMDR<br> | Other: Eye Movement Desensitization Reprocessing (EMDR)<br>* EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.<br>|
| No Intervention: TAU<br>Treatment as usual (TAU) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD