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

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

Status: Enrolling

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

Treatments: Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT); Other: Treatment As Usual; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06050421

IIBSP-TDC-2022-123

Details and patient eligibility

About

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

Full 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

Enrollment: 96 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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96 participants in 3 patient groups

Treatment as Usual (TAU)

Other group

Description:

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:

Other: Treatment As Usual

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

Experimental group

Description:

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.

Treatment:

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

Healty controls

Other group

Description:

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

Treatment:

Other: No intervention