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Background <p>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 shown its efficacy in these patients or evaluated its neurobiological mechanism of action.</p> Methods <p>A randomized CT in weight restored adult 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.</p> Discussion <p>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.</p> Trial registration <p>The study has been registered in ClinicalTrials.gov in September 22, 2023. It can be found in <a href="https://classic.clinicaltrials.gov/ct2/show/NCT06050421">https://classic.clinicaltrials.gov/ct2/show/NCT06050421</a>. Trial Registration Number: NCT06050421.</p>

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Evaluating the efficacy of radically open dialectical behavior therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月18日

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  • Aina Avila-Parcet,
  • Ana Martín-Blanco,
  • Leonor Gawron,
  • Marta Cano,
  • Víctor De la Peña-Arteaga,
  • Mar Carceller-Sindreu,
  • Joaquim Soler,
  • Maria J. Portella,
  • Gloria Faustino,
  • Narcís Cardoner,
  • Cristina Carmona i Farrés

摘要

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 shown its efficacy in these patients or evaluated its neurobiological mechanism of action.

Methods

A randomized CT in weight restored adult 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.