Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa

NCT06050421 | Recruiting

• 1 other identifier: IIBSP-TDC-2022-123
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Anorexia Nervosa in Remission; Anorexia Nervosa Restricting Type

Keywords

anorexia nervosa, RODBT

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Clinical relapses

  6 months, 12 months

• Eating Disorder Inventory, EDI

  6 months, 12 monghs

• Autism-Spectrum Quotient, AQ

  6 months, 12 months

• Rosenberg Self-Esteem Scale, RSE.

  6 months, 12 months

• Inventory of Interpersonal Problems (IIP-64)

  6 months, 12 months

Study Arms (3)

Treatment as Usual (TAU)

OTHER

The 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

Other: Treatment As Usual

TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT)

EXPERIMENTAL

2\. TAU + skills of the RO-DBT: In this treatment branch, a RO-DBT skills training therapy will be added to TAU. Treatment and therapists: RO DBT skills training consists of a 30-week intervention program in which a set of skills specifically designed to treat overcontrol are taught on an ongoing basis. The duration of each session is 2 hours. Table X provides an overall summary of each skill training session content. Detailed and extensive information about the treatment can be found elsewhere \[24\], \[34\]. Three clinical psychologists and one psychiatrist will conduct the treatment, all of whom have undergone extensive training in RO DBT. A maximum of two therapists will be in charge of each session, and the same two therapists will go throughout each group intervention. The team will be supervised by an approved RO DBT supervisor to improve therapeutic skills and ensure adherence to the protocol.

Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT)

Healty controls

OTHER

All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.

Other: No intervention

Interventions

Radically Open Dialectical Behaviour Therapy (RO-DBT) BEHAVIORAL

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.

Also known as: non

TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT)

Treatment As Usual OTHER

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

Treatment as Usual (TAU)

No intervention OTHER

All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.

Healty controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 90% of people who have AN are women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Fundació La Marató de TV3: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 24199611 BACKGROUND

• 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.

  PMID: 25346237 BACKGROUND

• 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.

  PMID: 33524917 BACKGROUND

• Avila-Parcet A, Martin-Blanco A, Gawron L, Cano M, Pena-Arteaga V, Carceller-Sindreu M, Soler J, Portella MJ, Faustino G, Cardoner N, Carmona I Farres C. Evaluating the efficacy of radically open dialectical behavior therapy (RO-DBT) in patients with anorexia nervosa: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2025 Apr 18;25(1):403. doi: 10.1186/s12888-025-06854-9.

  PMID: 40251556 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Cristina Carmona

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Carmona, Doctor

CONTACT

0034650003427; ccarmonaf@santpau.cat

Aina Avila

CONTACT

aavila@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: September 22, 2023
• Study Start: June 22, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)