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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03972033
Other study ID # EMDRvsCBT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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