Clinical trial NCT06050421: Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa
Official title: Evaluating the Efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in Patients With Anorexia Nervosa: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Anorexia Nervosa in Remission
Anorexia Nervosa Restricting Type
Keywords: anorexia nervosa, RODBT
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2023-09-22
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
timeFrame: 6 months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
timeFrame: 12 months
Secondary outcomes:
measure: Clinical relapses
timeFrame: 6 months, 12 months
measure: Eating Disorder Inventory, EDI
timeFrame: 6 months, 12 monghs
measure: Autism-Spectrum Quotient, AQ
timeFrame: 6 months, 12 months
measure: Rosenberg Self-Esteem Scale, RSE.
timeFrame: 6 months, 12 months
measure: Inventory of Interpersonal Problems (IIP-64)
timeFrame: 6 months, 12 months
measure: Social Connectedness Scale-Revised, SCS-R
timeFrame: 6 months, 12 months
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: 6 months, 12 months
measure: Neuroimaging variables
timeFrame: 6 months, 12 months
measure: Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,
timeFrame: 6 months, 12 months
measure: Assessed with the Questionnaire envy in adults, CEA
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Cristina Carmona
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.