Emotional Dysregulation, Maladaptive Overcontrol in Anorexia - Effect of Radically Open Dialectic… (NCT06244576) | Clinical Trial Compass
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Emotional Dysregulation, Maladaptive Overcontrol in Anorexia - Effect of Radically Open Dialectical Behaviour Therapy
Sweden31 participantsStarted 2023-09-15
Plain-language summary
This clinical trial employs a two-fold approach, utilizing a single-arm feasibility design within a larger multiple baseline experimental case series study framework over 32 weeks. The study aims to investigate both the feasibility and efficacy of Radically Open Dialectical Behaviour Therapy (RO-DBT) in patients with anorexia nervosa (AN). Feasibility will be assessed through treatment retention, data collection engagement, patient satisfaction, and the occurrence of adverse events. Efficacy outcomes will focus on RO-DBT's impact on ED psychopathology, obsessive-compulsive personality traits, EDR, and BMI.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
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:
* Diagnosis of anorexia nervosa or atypical nervosa (i.e., in partial remission with a BMI above \~18.5 but meets criteria B and/or C) according to the Diagnostic and Statistical Manual fifth edition (DSM-5)
* Signed written informed consent form
* Age 16-65
* Sufficient knowledge of Swedish
Exclusion Criteria:
* Substance dependence
* Not willing to accept randomization
* Undergoing simultaneous psychotherapy via another healthcare provider
* Intellectual disability
* Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.
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
The Eating Disorder Examination Questionnaire (EDE-Q)