A Controlled, Single-blind Pilot Study of EMDR in Bipolar, Subsyndromal Patients With Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Major affective episode in last 3 months
- •Active drug abuse/dependency
- •Neurological disease
- •Suicidal thoughts/ideation
- •Prior treatment EMDR
- •DES > 25
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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)
研究者
Benedikt Amann
Senior researcher
FIDMAG Germanes Hospitalàries