Bipolar Disorder, PTSD
Conditions
Keywords
EMDR, bipolar disorder, trauma, subsyndromal symptoms, PTSD
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.
Interventions
EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
Sponsors
FIDMAG Germanes Hospitalàries
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| The EMDR group improves statistically significant in trauma load when compared to TAU. | 3 months and 6 months | Secondary outcome measure includes changes in trauma scales (IES, CAPS)from baseline to 3 months and 6 months. |
| The EMDR group improves statistically significant in cognitive tests when compared to TAU. | 3 months and 6 months | Subjects underwent a neuropsychologcial battery to test various cognitive domains. |
| The EMDR group improves statistically significant in functioning when compared to TAU. | 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. |
| The EMDR group improves statistically significant in quality of life when compared to TAU. | 3 months and 6 months | Possible changes of Quality of life were tested in all subjects as well, using the SF-36. |
| Plasma levels of BDNF was statistically higher in the EMDR group after intervention when compared to TAU. | 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. |
Countries
Spain
Outcome results
None listed