Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eye Movement Desensitization and Reprocessing
- Sponsor
- University of Turin, Italy
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- changes in HRV
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
luca ostacoli
Full Professor
University of Turin, Italy
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
changes in HRV
Time Frame: 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
Time Frame: month 0 (T0)
fMRI in resting state phase and a second phase with a task
Changes in depressive symptoms
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: week 0, week 16, week 40
Hamilton Depression Rating Scale (HDRS)
psychiatric diagnosis
Time Frame: month 0 (T0)
Structured Clinical Interview for DSM-5 (SCID-5)
Secondary Outcomes
- 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))
- addressing potentially traumatizing events(month 0 (T0))
- 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 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 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 post-traumatic symptoms(month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup))