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Behavioral Intervention

Cognitive Behavioral Therapy for ARFID

N/A

Recruiting

Led By Helen Burton Murray, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study completion, an average of 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tested a therapy to help adults with digestive issues and difficulty eating, due to ARFID, to gain weight.

Who is the study for?

This trial is for adults with functional dyspepsia and ARFID, who've lost weight since the onset of FD. They must be stable enough for outpatient care, have not had CBT for FD or ARFID before, can use a computer with webcam, haven't changed medications recently, speak English fluently, and don’t have certain medical conditions like psychosis or recent surgeries.

What is being tested?

The study tests an exposure-based cognitive behavioral therapy (CBT) specifically designed to treat avoidant/restrictive food intake in individuals suffering from functional dyspepsia. Participants are randomly assigned to receive this treatment to see if it helps improve their condition.

What are the potential side effects?

Since the intervention involves therapy rather than medication, typical drug side effects aren't expected. However, participants may experience emotional discomfort or increased anxiety as they confront avoided foods during the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study completion, an average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study completion, an average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, an average of 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment completion

Client Satisfaction

Enrollment

+2 more

Secondary study objectives

Dyspepsia

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937

irritability

100%

80%

60%

40%

20%

Study treatment Arm

MESH

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral TherapyExperimental Treatment1 Intervention

Subjects will receive cognitive behavioral therapy for functional dyspepsia with avoidant restrictive food intake disorder.

Group II: Usual CareActive Control1 Intervention

In the usual care condition, participants will be allowed to continue with treatment they are already receiving at the time of randomization, and we will collect detailed data on the nature of these interventions. Participants will be allowed to pursue non study treatments in this condition.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy

2016

Completed Phase 4

~3120

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