Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- changes in HRV
研究概览
简要总结
Depression is one of the most common invalidating mental disorders, ranked by World Health Organization as the single largest contributor to global disability. Current recommended treatments for depression include antidepressant medication and according to guidelines, Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT). Despite encouraging preliminary results (e.g., Matthijssen et al., 2020), Eye Movement Desensitization and Reprocessing (EMDR) therapy is not yet recognized as an effective therapy for depression by APA and NICE. The project aims to conduct a large multisite study that addresses the shortcomings of previous efficacy research on EMDR for depression. The primary aim is to evaluate the effectiveness of EMDR therapy in reducing depressive symptoms in adults with major depression as compared to CBT. Secondary aims of the study are the effectiveness of EMDR, as compared to CBT and TAU, in improving anxiety, and other symptoms. It is hypothesized that EMDR is not inferior to CBT.
详细描述
The study is a multicenter clinical randomized controlled trial, conducted in Italy, USA and UK that will assess the effectiveness of EMDR therapy compared to CBT and TAU. Patients will be recruited at four clinical centers: Turin and Rome in Italy, and Kansas City in USA. The study protocol was approved by the local research ethics committee in each of the countries where the intervention is implemented.
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)
盲法说明
Outcomes assessors doesn't know the patient group assignment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •a score of at least 20 on Beck's Depression Inventory-II (BDI-II);
- •having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;
- •legal capacity to consent to the treatment.
排除标准
- •diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);
- •diagnosis of complex PTSD (assessed with the ITQ);
- •history of psychotic symptoms or schizophrenia;
- •bipolar disorder or dementia;
- •cluster A and B severe personality disorders;
- •dissociative symptoms (DES-B score >2);
- •any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study;
- •a serious, unstable medical condition;
- •a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income);
- •being pregnant;
- •acute suicidality that needs hospitalization
研究组 & 干预措施
Eye Movement Desensitization and Reprocessing
The DeprEND manualized protocol (Hofmann, Ostacoli, et al., 2015) is based on the eight-phase protocol by Shapiro (2001) that was adapted for the treatment of depression by the European Depression EMDR Network and used in previous studies (Hase et al., 2015; Hofmann et al., 2014; Ostacoli et al., 2018). EMDR targets will be selected using the Adaptive Information Processing model that looks for stressful events linked with depression. The DeprEnd Fidelity Rating Scale will be used to assess treatment fidelity. The scale will be completed by trained EMDR therapists who will listen to the audio recordings of the sessions.
In each centre, EMDR is provided by psychotherapists specialized in Level II EMDR and with a minimum of three years of experience in treating patients with depression. They receive extensive training and supervision in the manualized protocol established for the study, from a certified senior EMDR instructor.
干预措施: EMDR (Behavioral)
Cognitive Behavioral Therapy
Treatment protocol is based on the principles described by Beck (Beck et al., 1979) will be utilized. The treatment includes behavioral activation and cognitive restructuring with homework assignments. In each centre, CBT treatment is performed by psychotherapists with certified training in CBT techniques and a minimum of three years of experience in treating patients with depression. They receive regular CBT supervision to ensure that the quality of their CBT treatment was maintained.
干预措施: CBT (Behavioral)
结局指标
主要结局
changes in HRV
时间窗: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
HRV detection during hdEEG assessment
changes in fMRI
时间窗: month 0 (T0)
fMRI in resting state phase and a second phase with a task
Changes in depressive symptoms
时间窗: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
Beck Depression Inventory II (BDI-II)
changes in cognitive component of depressive syndrome
时间窗: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Beck Hopelessness Scale (BHS)
changes in HD-EEG
时间窗: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
HD-EEG in resting state phase and a second phase with a task
changing in depressive symptoms
时间窗: month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Patient Health Questionnaire-9 (PHQ-9)
changes in depressive symptoms
时间窗: week 0, week 16, week 40
Hamilton Depression Rating Scale (HDRS)
psychiatric diagnosis
时间窗: month 0 (T0)
Structured Clinical Interview for DSM-5 (SCID-5)
次要结局
- addressing potentially traumatizing events(month 0 (T0))
- changing in quality of sleep, in particular insomnia(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- assessing childhood trauma(month 0 (T0))
- evaluating the quality of relationships(month 0 (T0))
- changing in the dimensions of the emotional style(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in physical activity habits(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in suicidal thinking(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in dissociative symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in post-traumatic stress symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- assessing disability and functional impairment as a result of treatment(1 month time frame)
- changing in autonomic symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in the emotional regulation(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in stress(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
- changing in anxiety symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week)
- changing in post-traumatic symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))
研究者
luca ostacoli
Full Professor
University of Turin, Italy