RCT Comparing EMDR and CBT for Treatment of Resistant Depression

Last updated: March 9, 2022
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Depression (Adult And Geriatric)

Habit Reversal

Treatment

N/A

Clinical Study ID

NCT03972033
EMDRvsCBT
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. a diagnosis of Major Depressive Disorder, single episode or recurrent, according tothe 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 maintainedstable during treatment;
  4. legal capacity to consent to the treatment.

Exclusion

Exclusion Criteria:

  1. diagnosis of current PTSD (assessed with MINI-Plus and the International TraumaQuestionnaire - 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 losswithout any other source of income);
  10. being pregnant;
  11. acute suicidality that needs hospitalization

Study Design

Total Participants: 128
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126
    Italy

    Active - Recruiting

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