Randomized controlled clinical trial to evaluate the efficacy of "Radically Open Dialectical Behaviour Therapy" in patients with eating disorders: a proof-of-concept study.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
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.
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
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGQuality 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.
Time frame: 6 months
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.
Time frame: 12 months
Clinical relapses
having BMI below 19kg/m2 during two or more weeks, and having a punctuation of the EAT above 21.
Time frame: 6 months, 12 months
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
Time frame: 6 months, 12 monghs
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.
Time frame: 6 months, 12 months
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.
Time frame: 6 months, 12 months
Inventory of Interpersonal Problems (IIP-64)
A screening measure for avoidant personality disorder (AVPD), and for personality disorder (PD) in general.
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All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.
Time frame: 6 months, 12 months
Social Connectedness Scale-Revised, SCS-R
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.
Time frame: 6 months, 12 months
Depression Anxiety and Stress Scale 21 (DASS-21)
A self-report scale designed to measure the negative emotional states of depression, anxiety and stress.
Time frame: 6 months, 12 months
Neuroimaging variables
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.
Time frame: 6 months, 12 months
Clinical Outcomes in Routine Evaluation-Outcome Measure, CORE-OM,
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.
Time frame: 6 months, 12 months
Assessed with the Questionnaire envy in adults, CEA
This is composed of 24 items representing all theoretical dimensions. Higher scores show higher envy.
Time frame: 6 months, 12 months