RCT Comparing EMDR and CBT for Treatment of Resistant Depression

NCT ID: NCT03972033

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eye Movement Desensitization and Reprocessing

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.

Group Type: EXPERIMENTAL

EMDR

Intervention Type: 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.

Cognitive Behavioral Therapy

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.

Group Type: ACTIVE_COMPARATOR

CBT

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Eye Movement Desensitization and Reprocessing; Cognitive Behavioral Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMDR Europe

INDUSTRY

Sponsor Role: collaborator

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

luca ostacoli

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luca Ostacoli, Associate Professor

Role: CONTACT

luca.ostacoli@unito.it

3335613155

Facility Contacts

Luca Ostacoli, Assistant Professor

Role: primary

luca.ostacoli@unito.it

3335613155

Other Identifiers

EMDRvsCBT

Identifier Type: -

Identifier Source: org_study_id