RCT Comparing EMDR and CBT for Treatment of Resistant Depression

NCT03972033 | Unknown

• 1 other identifier: EMDRvsCBT
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

depression; neurobiology of emotions; Cognitive Behavioral Therapy; Eye Movement Desensitization and Reprocessing; trauma; psychotherapy

Outcome Measures

Primary Outcomes (8)

• 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).

• changes in depressive symptoms

  Hamilton Depression Rating Scale (HDRS)

  week 0, week 16, week 40

• 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)

• 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)

• changes in fMRI

  fMRI in resting state phase and a second phase with a task

  month 0 (T0)

• 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)

• psychiatric diagnosis

  Structured Clinical Interview for DSM-5 (SCID-5)

  month 0 (T0)

• 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 Outcomes (15)

• addressing potentially traumatizing events

  month 0 (T0)

• assessing childhood trauma

  month 0 (T0)

• evaluating the quality of relationships

  month 0 (T0)

• changing in dissociative symptoms

  month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)

• changing in autonomic symptoms

  month 0 (T0, baseline), month 4 (T1, post-treatment), month 10 (T2, followup), month 22 (T3, followup)

Study Arms (2)

Eye Movement Desensitization and Reprocessing

EXPERIMENTAL

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.

Behavioral: EMDR

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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.

Behavioral: CBT

Interventions

EMDR BEHAVIORAL

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.

Also known as: Eye Movement Desensitization and Reprocessing

Eye Movement Desensitization and Reprocessing

CBT BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead
• EMDR Europe: collaborator

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Depression; Wounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Luca Ostacoli, Associate Professor

CONTACT

3335613155; luca.ostacoli@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors doesn't know the patient group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The design of the study is a randomized controlled clinical trial.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: June 3, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

IT (1)