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

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