RCT Comparing EMDR and CBT for Treatment of Resistant Depression

Not Applicable

Recruiting

• Conditions: Neurobiological Processing; Eye Movement Desensitization and Reprocessing; Cognitive Behavioral Therapy; Depression; High Definition Electroencefalography; Functional Magnetic Resonance Imaging; Heart Rate Variability
• Interventions: Behavioral: EMDR; Behavioral: CBT

• Registration Number: NCT03972033
• Lead Sponsor: University of Turin, Italy

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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-05-30
• Study First Posted: 2019-06-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-14
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. a diagnosis of Major Depressive Disorder, single episode or recurrent, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
2. a score of at least 20 on Beck's Depression Inventory-II (BDI-II);
3. having received ADM treatment with a stable dose for at least six weeks and maintained stable during treatment;
4. legal capacity to consent to the treatment.

Exclusion Criteria

1. diagnosis of current PTSD (assessed with MINI-Plus and the International Trauma Questionnaire - ITQ, Cloitre et al., 2018);
2. diagnosis of complex PTSD (assessed with the ITQ);
3. history of psychotic symptoms or schizophrenia;
4. bipolar disorder or dementia;
5. cluster A and B severe personality disorders;
6. dissociative symptoms (DES-B score >2);
7. any substance-related abuse or dependence disorder (except those involving nicotine) in the 6 months prior to the study;
8. a serious, unstable medical condition;
9. a severely unstable social and economic condition (e.g. no fixed abode; job loss without any other source of income);
10. being pregnant;
11. acute suicidality that needs hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eye Movement Desensitization and Reprocessing	EMDR	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.
Cognitive Behavioral Therapy	CBT	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.

Primary Outcome Measures

Name	Time	Method
changes in HRV	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	month 0 (T0)	fMRI in resting state phase and a second phase with a task
Changes in depressive symptoms	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	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	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	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	week 0, week 16, week 40	Hamilton Depression Rating Scale (HDRS)
psychiatric diagnosis	month 0 (T0)	Structured Clinical Interview for DSM-5 (SCID-5)

Secondary Outcome Measures

Name	Time	Method
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)	Insomnia Severity Index (ISI)
addressing potentially traumatizing events	month 0 (T0)	Traumatic Experience Checklist (TEC)
assessing childhood trauma	month 0 (T0)	Childhood Trauma Questionnaire (CTQ)
evaluating the quality of relationships	month 0 (T0)	Relationship Questionnaire (RQ)
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)	Emotional Style Questionnaire (ESQ)
changing in physical activity habits	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	International Physical Activity Questionnaire Short Form (IPAQ-SF)
changing in suicidal thinking	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	Paykel Suicide Scale
changing in dissociative symptoms	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	Brief Dissociative Experiences Scale (DES-B)
changing in post-traumatic stress symptoms	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	PTSD Checklist for DSM-5 (PCL-5)
assessing disability and functional impairment as a result of treatment	1 month time frame	Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)
changing in autonomic symptoms	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	Composite Autonomic Symptom Score (COMPASS-31)
changing in the emotional regulation	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	Difficulties in Emotion Regulation Scale (DERS)
changing in stress	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	Perceived Stress Scale (PSS)
changing in anxiety symptoms	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week	General Anxiety Disorder-7 (GAD-7)
changing in post-traumatic symptoms	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)	International Trauma Questionnaire

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino; 🇮🇹 Torino, Italy