Interoceptive Exposure for Adolescents With Low Weight Eating Disorders (NCT05763849) | Clinical Trial Compass
RecruitingNot Applicable
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
United States120 participantsStarted 2023-03-14
Plain-language summary
This project includes a parallel group randomized controlled trial comparing two psychological treatments: 1) Exposure-based Family Therapy (IE) vs. 2) Family Based Therapy (FBT) for low weight eating disorders with 12 month follow-up. Primary outcomes are expected body weight and clinical impairment. Three mechanisms of change (Autonomous Eating, Non-Judgmental Body Awareness, and Extinction Learning) will be examined in a process mediation models of change.
Who can participate
Age range
12 Years – 18 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:
* Aged 12-18
* Speak English
* Permission from pediatrician or equivalent to receive outpatient care
* Clinically significant restriction of food intake by EDA-5 or evidence of persistent food avoidance from patient or guardians
* Evidence of the inability to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories
Exclusion Criteria:
* Comorbid psychotic or bipolar disorder
* Active suicidal ideation
* Current substance dependence
* Psychiatric medication initiated or dosage changes \<2 weeks from baseline
* Major medical illness (e.g., diabetes mellitus, Crohn's disease, etc.)
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.