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

backgroundAnorexia 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.

methodsA 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 registrationThe 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.