An interventional study of Radically Open Dialectical Behaviour Therapy (RO-DBT) and Treatment As Usual in Anorexia Nervosa, Anorexia Nervosa in Remission and Anorexia Nervosa Restricting Type, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-22.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Treatment
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
411 studies on the registry are indexed under Anorexia; 67 are open to participants now.
This study's planned enrollment of 96 is above the median of 41 across 287 interventional studies indexed under Anorexia.
Browse Anorexia studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Treatment As Usual
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.
Behavioral: Radically Open Dialectical Behaviour Therapy (RO-DBT)
All controls will complete data collection notebook and will undergo the same neuroimaging acquisition. There will not be follow-up for this group.
Other: No intervention
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.
Also known as: non
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
All 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.
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.
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
Plan to share: No
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau