Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa
NCT ID: NCT06050421
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2023-06-22
2026-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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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
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
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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
FEMALE
Yes
Sponsors
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Fundació La Marató de TV3
OTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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Cristina Carmona
Role: PRINCIPAL_INVESTIGATOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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IIBSP-TDC-2022-123
Identifier Type: -
Identifier Source: org_study_id
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