NCT03972033

RCT Comparing EMDR and CBT for Treatment of Resistant Depression

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Turin, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-02-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2019-06-03
• Last updated: 2022-03-14

Locations

1 site across 1 country: Italy