Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa; Anorexia Nervosa Restricting Type; Anorexia Nervosa in Remission

• Registration Number: NCT06050421
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.

Detailed 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

Study Timeline

• Study First Submitted: 2023-06-15
• Study Start: 2023-06-22
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q	12 months	A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.

Secondary Outcome Measures

Name	Time	Method
Clinical relapses	6 months, 12 months	having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.
Eating Disorder Inventory, EDI	6 months, 12 monghs	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms
Social Connectedness Scale-Revised, SCS-R	6 months, 12 months	This scale assesses the degree to which a person feel connected to others in their social environment. Scores range from 20 to 120 higher score indicates more connectedness to others.
Assessed with the Questionnaire envy in adults, CEA	6 months, 12 months	This is composed of 24 items representing all theoretical dimensions. Higher scores show higher envy.
Autism-Spectrum Quotient, AQ	6 months, 12 months	A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.
Rosenberg Self-Esteem Scale, RSE.	6 months, 12 months	A self report questionarie that assesses self steem. The scale ranges from 0-30. Higher scores mean higher self-esteem. The range scores is 0-60.
Depression Anxiety and Stress Scale 21 (DASS-21)	6 months, 12 months	A self-report scale designed to measure the negative emotional states of depression, anxiety and stress.
Inventory of Interpersonal Problems (IIP-64)	6 months, 12 months	A screening measure for avoidant personality disorder (AVPD), and for personality disorder (PD) in general.
Neuroimaging variables	6 months, 12 months	structural and functional magnetic resonance images will be acquired at baseline and at 1- month follow-up for all the participants, and in one single occasion for the healthy control group.
Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,	6 months, 12 months	A self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. The broad spectrum nature of the measure means it captures a wide variety of problems associated with mental health difficulties, beyond typical symptom measures.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain