Evaluating the efficacy of Radically Open Dialectical Behavior Therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial-Reference-Cited by-同舟云学术

Evaluating the efficacy of Radically Open Dialectical Behavior Therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial

Published:2024-06-17 Issue: Volume: Page:
ISSN:
Container-title:
language:
Short-container-title:

Author:

Avila-Parcet Aina¹,Martín-Blanco Ana²,Gawron Leonor¹,Cano Marta³,Peña-Arteaga Víctor De La³,Carceller-Sindreu Mar²,Soler Joaquim²,Portella Maria J⁴,Faustino Gloria⁵,Cardoner Narcís²,Farrés Cristina Carmona²

Affiliation:

1. Hospital de la Santa Creu i Sant Pau

2. Hospital de la Santa Creu i Sant Pau, IR Sant Pau, UAB

3. Sant Pau Mental Health Research Group, Institut de Recerca Sant Pau (IR SANT PAU)

4. Sant Pau Mental Health Research Group, Institut de Recerca Sant Pau (IR SANT PAU), UAB

5. Universitat Autònoma de Barcelona (UAB)

Abstract

Background: Anorexia nervosa (AN) is a severe and disabling disorder, with relapse rates as high as 50% after the first episode, posing a significant challenge for clinicians. Most therapies excessively focus on nourishment, resulting in temporary weight restoration but with no improvements in general well-being and quality of life. Radically Open Dialectical Behavior Therapy (RO-DBT) is a transdiagnostic treatment designed to address overcontrol, a key aspect in the functioning of patients with AN. To date, no clinical trial (CT) has proven its efficacy in these patients or evaluated its neurobiological mechanism of action. Methods: A randomized CT in AN patients will be conducted, with one group receiving treatment as usual (TAU) and the other TAU plus RO-DBT, with the main outcome being quality of life. Secondary variables will include eating disorders (EDs) symptoms, overcontrol characteristics, autistic traits, and neuroimaging changes. Discussion: The results will address a gap in knowledge regarding AN treatment, with the expectation that patients receiving TAU with RO-DBT will exhibit improved quality of life and experience fewer relapses at the one-year follow-up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms. Trial registration: The study has been registered in ClinicalTrials.gov in September 22, 2023. It can be found in https://classic.clinicaltrials.gov/ct2/show/NCT06050421. Trial Registration Number: NCT06050421

Publisher

Research Square Platform LLC

Reference38 articles.

1. Ágh T, Kovács G, Supina D, Pawaskar M, Herman BK, Vokó Z et al. A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder. Eat Weight Disord [Internet]. 2016 Sep 1 [cited 2023 May 18];21(3):353–64. https://pubmed.ncbi.nlm.nih.gov/26942768/.

2. Hoek HW. Review of the worldwide epidemiology of eating disorders. Curr Opin Psychiatry [Internet]. 2016 Oct 1 [cited 2023 May 18];29(6):336–9. https://pubmed.ncbi.nlm.nih.gov/27608181/.

3. Epidemiology, health-related quality of life and economic burden of binge eating disorder: a systematic literature review;Ágh T;Eat Weight Disord,2015

4. Khalsa SS, Portnoff LC, McCurdy-McKinnon D, Feusner JD. What happens after treatment? A systematic review of relapse, remission, and recovery in anorexia nervosa. J Eat Disord [Internet]. 2017 Jun 14 [cited 2023 May 18];5(1). https://pubmed.ncbi.nlm.nih.gov/28630708/.

5. Löwe B, Zipfel S, Buchholz C, Dupont Y, Reas DL, Herzog W. Long-term outcome of anorexia nervosa in a prospective 21-year follow-up study. Psychol Med [Internet]. 2001 [cited 2023 May 18];31(5):881–90. https://pubmed.ncbi.nlm.nih.gov/11459385/.