Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa (RODBT-AN)

September 15, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment as Usual (TAU)
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
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
Experimental: TAU + Radically Open Dialectical Behaviour Therapy (RO-DBT)
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)
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 Names:
  • non
Other: Healty controls
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
All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
Time Frame: 6 months
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
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical relapses
Time Frame: 6 months, 12 months
having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.
6 months, 12 months
Eating Disorder Inventory, EDI
Time Frame: 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
6 months, 12 monghs
Autism-Spectrum Quotient, AQ
Time Frame: 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.
6 months, 12 months
Rosenberg Self-Esteem Scale, RSE.
Time Frame: 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.
6 months, 12 months
Inventory of Interpersonal Problems (IIP-64)
Time Frame: 6 months, 12 months
A screening measure for avoidant personality disorder (AVPD), and for personality disorder (PD) in general.
6 months, 12 months
Social Connectedness Scale-Revised, SCS-R
Time Frame: 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.
6 months, 12 months
Depression Anxiety and Stress Scale 21 (DASS-21)
Time Frame: 6 months, 12 months
A self-report scale designed to measure the negative emotional states of depression, anxiety and stress.
6 months, 12 months
Neuroimaging variables
Time Frame: 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.
6 months, 12 months
Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,
Time Frame: 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.
6 months, 12 months
Assessed with the Questionnaire envy in adults, CEA
Time Frame: 6 months, 12 months
This is composed of 24 items representing all theoretical dimensions. Higher scores show higher envy.
6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Fundació La Marató de TV3

Investigators

  • Principal Investigator: Cristina Carmona, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 15, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 15, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-TDC-2022-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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