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Behavioral Intervention

Mindfulness-Based Therapy for Avoidant Restrictive Food Intake Disorder

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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I have been diagnosed with Avoidant Restrictive Food Intake Disorder.

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I am a parent of a child aged 12-18 diagnosed with ARFID.

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I am between 12 and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MBIE-adapted Therapy Suitability and Acceptability Scale to measure Patient MBIE Therapy Tolerability

Secondary outcome measures

Change in Expected Body Weight Percentage

Change in total calories consumed

Dropout Rate

+4 more

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,569 Total Patients Enrolled

Robyn Sysko, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

8 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more individuals being sought out for participation in this experiment?

"Affirmative. Analysis of clinicaltrials.gov indicates that this medical trial is presently seeking out participants, having first been posted on October 17th 2023 and last updated October 26th 2023. 57 volunteers are required from a single location."

Answered by AI

How many participants is the clinical trial recruiting?

"Affirmative, the research posted on clinicaltrials.gov attests that this trial is actively recruiting people to participate in it. It was first declared on October 17th 2023 and most recently updated on October 26th 2023. This study necessitates 57 volunteers at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder

Robyn Sysko 2023. "Family-Based Interoceptive Exposure for Avoidant Restrictive Food Intake Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110806.