Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— RODBT-AN  

Official title:

Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050421
• Other study ID #: IIBSP-TDC-2022-123
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Cristina Carmona, Doctor
• Phone: 0034650003427
• Email: ccarmonaf[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Anorexia Nervosa in Remission
• Anorexia Nervosa Restricting Type

Intervention

Behavioral:
• Radically Open Dialectical Behaviour Therapy (RO-DBT)
RO-DBT is a transdiagnostic intervention specifically designed to treat a spectrum of disorders characterized by excessive overcontrol such as resistant depression, avoidant and obsessive-compulsive personality disorders, mood disorders, anorexia nervosa and autism spectrum disorder.

Other:
• Treatment As Usual
he TAU condition will follow the standard treatment of the EDs Unit of the HSCSP for AN. This treatment consists of visits with a psychiatrist with a frequency decided according to the clinical situation and, in some cases, nursing follow-up and/or relapse prevention group that takes place twice per month
• No intervention
All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Fundació La Marató de TV3

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Chen EY, Segal K, Weissman J, Zeffiro TA, Gallop R, Linehan MM, Bohus M, Lynch TR. Adapting dialectical behavior therapy for outpatient adult anorexia nervosa--a pilot study. Int J Eat Disord. 2015 Jan;48(1):123-32. doi: 10.1002/eat.22360. Epub 2014 Oct 27. — View Citation

Isaksson M, Ghaderi A, Ramklint M, Wolf-Arehult M. Radically open dialectical behavior therapy for anorexia nervosa: A multiple baseline single-case experimental design study across 13 cases. J Behav Ther Exp Psychiatry. 2021 Jun;71:101637. doi: 10.1016/j.jbtep.2021.101637. Epub 2021 Jan 12. — View Citation

Lynch TR, Gray KL, Hempel RJ, Titley M, Chen EY, O'Mahen HA. Radically open-dialectical behavior therapy for adult anorexia nervosa: feasibility and outcomes from an inpatient program. BMC Psychiatry. 2013 Nov 7;13:293. doi: 10.1186/1471-244X-13-293. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q	A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.	6 months
Primary	Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q	A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.	12 months
Secondary	Clinical relapses	having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.	6 months, 12 months
Secondary	Eating Disorder Inventory, EDI	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms	6 months, 12 monghs
Secondary	Autism-Spectrum Quotient, AQ	A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.	6 months, 12 months
Secondary	Rosenberg Self-Esteem Scale, RSE.	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.	6 months, 12 months
Secondary	Inventory of Interpersonal Problems (IIP-64)	A screening measure for avoidant personality disorder (AVPD), and for personality disorder (PD) in general.	6 months, 12 months
Secondary	Social Connectedness Scale-Revised, SCS-R	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.	6 months, 12 months
Secondary	Depression Anxiety and Stress Scale 21 (DASS-21)	A self-report scale designed to measure the negative emotional states of depression, anxiety and stress.	6 months, 12 months
Secondary	Neuroimaging variables	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.	6 months, 12 months
Secondary	Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,	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.	6 months, 12 months
Secondary	Assessed with the Questionnaire envy in adults, CEA	This is composed of 24 items representing all theoretical dimensions. Higher scores show higher envy.	6 months, 12 months