RCT Comparing EMDR and CBT for Treatment of Resistant Depression

Depression Clinical Trial

Official title:

Multicenter RCT Comparing EMDR and CBT Efficacy for Treatmen of Resistant Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972033
• Other study ID #: EMDRvsCBT
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2022
• Source: University of Turin, Italy
• Contact: Luca Ostacoli, Associate Professor
• Phone: 3335613155
• Email: luca.ostacoli[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Behavioral Therapy
• Depression
• Depressive Disorder
• Eye Movement Desensitization and Reprocessing
• Functional Magnetic Resonance Imaging
• Heart Rate Variability
• High Definition Electroencefalography
• Neurobiological Processing

Intervention

Behavioral:
• EMDR
Treatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision. As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.
• CBT
Treatments will be independent and blinded to the clinical psychologists conducting the clinical assessments. EMDR and CBT treatments will be provided for 16 weeks, each comprising 16 weekly individual sessions. Interventions will be conducted according to published treatment manuals. All treatment sessions will be video recorded for fidelity rating and supervision. As a safety criterion, if severe worsening of symptoms is observed, patients are withdrawn from their assigned treatment arm.

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza di Torino	Torino

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	EMDR Europe

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in depressive symptoms	Beck Depression Inventory II (BDI-II)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup).
Primary	changes in depressive symptoms	Hamilton Depression Rating Scale (HDRS)	week 0, week 16, week 40
Primary	changes in cognitive component of depressive syndrome	Beck Hopelessness Scale (BHS)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Primary	changes in HD-EEG	HD-EEG in resting state phase and a second phase with a task	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Primary	changes in fMRI	fMRI in resting state phase and a second phase with a task	month 0 (T0)
Primary	changes in HRV	HRV detection during hdEEG assessment	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Primary	psychiatric diagnosis	Structured Clinical Interview for DSM-5 (SCID-5)	month 0 (T0)
Primary	changing in depressive symptoms	Patient Health Questionnaire-9 (PHQ-9)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week
Secondary	addressing potentially traumatizing events	Traumatic Experience Checklist (TEC)	month 0 (T0)
Secondary	assessing childhood trauma	Childhood Trauma Questionnaire (CTQ)	month 0 (T0)
Secondary	evaluating the quality of relationships	Relationship Questionnaire (RQ)	month 0 (T0)
Secondary	changing in dissociative symptoms	Brief Dissociative Experiences Scale (DES-B)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in autonomic symptoms	Composite Autonomic Symptom Score (COMPASS-31)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in the emotional regulation	Difficulties in Emotion Regulation Scale (DERS)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in the dimensions of the emotional style	Emotional Style Questionnaire (ESQ)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in quality of sleep, in particular insomnia	Insomnia Severity Index (ISI)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in physical activity habits	International Physical Activity Questionnaire Short Form (IPAQ-SF)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in post-traumatic symptoms	International Trauma Questionnaire	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in suicidal thinking	Paykel Suicide Scale	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in stress	Perceived Stress Scale (PSS)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	changing in post-traumatic stress symptoms	PTSD Checklist for DSM-5 (PCL-5)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)
Secondary	assessing disability and functional impairment as a result of treatment	Sheehan Disability Scale for Treatment Induced Impairment (SDS-T)	1 month time frame
Secondary	changing in anxiety symptoms	General Anxiety Disorder-7 (GAD-7)	month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup) and every week