Evaluation of the Efficacy of Dissociation-Focused Cognitive Behavior Therapy: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Difference in Dissociative Experience Scale (DES)
研究概览
简要总结
Dissociative symptoms and disorders are particularly prevalent in the general population and among people suffering from psychiatric disorders. To date, no treatment has proven effective for this type of problem. Exploratory studies (without control group) have been carried out. Among these studies, dissociation-focused cognitive behavioral therapy (DF-CBT) seems promising. DF-CBT is based on a solid empirical model that has received numerous scientific evidence.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Membership of a social security scheme
- •Participant's express consent
- •Have at least one diagnosis of dissociative disorder among the following:
- •depersonalization/derealization disorder, dissociative identity disorder, unspecified dissociative disorder.
- •Be able to carry out psychotherapy sessions.
- •If taking psychiatric medication, treatment must have been stable for at least 30 days.
排除标准
- •Present one of the following current diagnoses: substance use disorder (excluding tobacco), neurodevelopmental disorder, anorexia nervosa, severe depressive disorder, schizophrenia spectrum disorder, bipolar disorder, personality disorder other than borderline personality disorder.
- •Present cognitive deficits.
- •Be engaged in psychotherapeutic work.
- •Be undergoing benzodiazepine treatment.
- •Pregnant women and breastfeeding women
研究组 & 干预措施
The control group will receive 9 weekly relaxation sessions.
The experimental group will receive 9 weekly sessions of DF-CBT psychotherapy.
干预措施: CBT-CD psychotherapy (Other)
结局指标
主要结局
Difference in Dissociative Experience Scale (DES)
时间窗: Between randomization and 3 months after
Difference in Dissociative Experience Scale (DES) between randomization and 3 months after. The DES assesses dissociation through 28 items. The total score ranges between 0 and 100, where high scores indicate high levels of dissociation.
次要结局
- Hetero-administered visual analogue scale(At randomization, 3 months and 6 months after)
- Dissociative Experiences Scale (DES)(At 6 months after randomization)
- Hospital Anxiety Depression Scale (HADS)(Randomization, 3 months and 6 months after)
- Dissociation Questionnaire (DIS-Q)(At randomisation, 3 months and 6 months after)
- Post traumatic stress disorder checklist scale (PCL-5)(Randomization, 3 months and 6 months after)
- Satisfaction With Life Scale (SWLS)(Randomization, 3 months and 6 months after)