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Behavioral Intervention
Mindfulness-Based Therapy for Avoidant Restrictive Food Intake Disorder
N/A
Waitlist Available
Led By Robyn Sysko, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of Avoidant Restrictive Food Intake Disorder, as assessed by the EDA-5
Parent has a child aged 12-18 with a diagnosis of ARFID
Must not have
Children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures)
Active suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will explore if mindfulness-based therapy can help youth with ARFID reduce the number of foods they avoid & develop mindfulness skills.
Who is the study for?
This trial is for English-speaking youths aged 12-18 with Avoidant Restrictive Food Intake Disorder (ARFID) and their parents. Participants must have permission from a pediatrician for outpatient care and not require hospitalization. Those on new or recently changed psychiatric meds, with major medical conditions, anatomical issues affecting eating, physical limitations preventing screen use, substance dependence, psychotic/bipolar disorders, or active suicidal thoughts cannot join.
What is being tested?
The study tests the effectiveness of a mindfulness-based interoceptive exposure (MBIE) therapy designed for families dealing with ARFID. It will assess how easy it is to recruit participants and collect data, determine if families find the MBIE approach acceptable and stick to it, and measure changes in food avoidance behaviors and mindfulness after treatment.
What are the potential side effects?
Since this intervention involves behavioral therapy rather than medication or invasive procedures, significant side effects are not anticipated. However, some participants may experience discomfort or emotional distress when facing feared foods during exposure exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Avoidant Restrictive Food Intake Disorder.
Select...
I am a parent of a child aged 12-18 diagnosed with ARFID.
Select...
I am between 12 and 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child can see and use a mouse without health risks.
Select...
I am currently having thoughts about harming myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability
Secondary study objectives
Change in Expected Body Weight Percentage
Change in total calories consumed
Dropout Rate
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mindfulness-based interoceptive exposure (MBIE)Experimental Treatment1 Intervention
Outpatient therapy for individuals with ARFID using mindfulness and exposures in a family-based therapy approach.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,822 Total Patients Enrolled
Robyn Sysko, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
8 Total Patients Enrolled