Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
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)
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
Factorial
Radically Open Dialectical Behaviour Therapy (RO-DBT)
BehavioralRO-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
Other interventionhe 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
Other interventionAll controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.
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.
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.
Clinical relapses
having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.
Eating Disorder Inventory, EDI
A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms
Autism-Spectrum Quotient, AQ
A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.
Rosenberg Self-Esteem Scale, RSE.
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.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Fundació La Marató de TV3
Collaborator
