Overview
Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
Description
Background: Up to 20% of patients with anorexia nervosa (AN) die and 50% relapse after the first episode, being its treatment a great challenge for clinicians. Most therapies excessively focus excessively on nourishment, which translates to temporarily restored weight with no improvements in psychosocial life. Radically Open Dialectical Behaviour Therapy (RO-DBT) is a transdiagnostic treatment designed to treat overcontrol, a key aspect in the functioning of patients with AN. To date no clinical trial (CT) has proved its efficacy on these patients or has demonstrated its biological underpinning mechanisms.
Methods: A randomized CT in AN patients will be conducted, where one group will receive treatment as usual (TAU) and the other one TAU with plus RO-DBT, being psychosocial adjustment the main outcome; other secondary variables will be ED symptoms, overcontrol characteristics, autistic traits and neuroimaging changes.
Discussion: The results will fill the a knowledge gap in AN treatment, expecting that patients who receive TAU with RO-DBT will have better social adjustment and less relapses at one year follow up. This is the first study examining neuroimaging changes in RO-DBT to better understand its underlying mechanisms
Eligibility
Inclusion Criteria:
- female patients
- aged between 18 to 65 years old,
- having a diagnosis of AN (DSM 5 criteria),
- having had weigh restoration treatment (normal BMI considered >19 kg/m2)
- having an overcontrol personality style assessed with the styles of coping Word-Pair Checklist scale (ASC-WP)
Exclusion Criteria:
- diagnosis of severe mental illness (schizophrenia or other psychosis, bipolar disorder, major depressive disorder, substance use disorder)
- diagnosis of borderline personality disorder (BPD) or positive result in McLean Screening Instrument for BPD
- mental retardation
- being under standardized psychotherapy at the baseline
- being illiterate or not able to understand Spanish language,
- being left-handed
- being pregnant for MRI requirements.