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CBT-Eb Plus EMDR Versus CBT-Eb in Patients With Eating Disorders

NCT03156959 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-05-10

No results posted yet for this study

Summary

Enhanced CBT (CBT-E) is an effective treatment for the majority of outpatients with an eating disorder; however in about 30% of patients remission is made difficult. This may be due to the concomitant presence of trauma. Therefore we expect that a combination of CBT-E and EMDR, which is the evidence based treatment for PTSD disorder, would enhance the remission probability. This trial has a parallel group randomized controlled design. All patients who will enter in contact with the Regional Reference Centre for Eating Disorders in Verona and will satisfy inclusion criteria will be randomized to the broad form of CBT-E (CBT-Eb) plus EMDR or CBT-Eb alone. Patients will be evaluated before the treatment, at the end of treatment and after 6 months post-treatment with a set of standardized measure to assess eating disorder symptoms and other possible predisposing and moderating factors. The efficacy of CBT-E vs CBT-E + EMDR will be evaluated at the end of the treatment and after 6 months in terms of global score of the Eating Disorder Examination. Moreover the changes in other secondary outcomes will be considered. This explorative study may suggest new hypothesis for larger RCTs in order to increase the knowledge on ED.

Conditions

  • Eating Disorder

Interventions

BEHAVIORAL

EMDR

The Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapy developed by Francine Shapiro (2001) that emphasizes disturbing memories as the cause of psychopathology. These memories and associated stimuli are inadequately processed and stored in an isolated memory network (Shapiro and Laliotis, 2010). The goal of EMDR is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms.

BEHAVIORAL

CBT-Eb

The broad form of Enhanced Cognitive Behavioural Therapy (CBT-Eb; Fairburn and colleagues, 2009) addresses psychopathological processes "external" to the eating disorder, such as clinical perfectionism, low self-esteem or interpersonal difficulties, which interact with the disorder itself.

Sponsors & Collaborators

  • Ruggeri, Mirella

    lead OTHER

Principal Investigators

  • Mirella Ruggeri, Prof · University of Verona, Section of Psychiatry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2022-05-31
Completion
2022-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156959 on ClinicalTrials.gov