Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa (NCT06050421) | Clinical Trial Compass
RecruitingNot Applicable
Radically Open Dialectical Behaviour Therapy in Patients With Anorexia Nervosa
Spain96 participantsStarted 2023-06-22
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
Timeframe: 6 months
2
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q
Timeframe: 12 months
Trial details
NCT IDNCT06050421
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau