Development and Testing of a Mobile App to Scale Delivery of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder

April 1, 2025 updated by: Paraskevi E. Kambanis, Massachusetts General Hospital
Avoidant/restrictive food intake disorder (ARFID) is a serious and impairing eating disorder - occurring in up to 4% of adults - for which most individuals do not have access to treatment. The proposed study aims to develop and test a mobile app to scale delivery of cognitive-behavioral therapy for ARFID. Knowledge gained will contribute to the development of a clinically accessible, scalable, inexpensive treatment for ARFID, a highly impairing disorder for which there are significant barriers to care access.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Current avoidant/restrictive food intake disorder based on DSM-5 criteria
  2. Must not have completed face-to-face CBT-AR at the Eating Disorders Clinical and Research Program at Massachusetts General Hospital
  3. Ability to speak, write, and understand English
  4. Residence in the United States
  5. Access to an internet-connected smartphone device

Exclusion Criteria:

  1. Underweight status (i.e., BMI < 18.5 kg/m2)
  2. Complete lack of oral intake or dependence on supplemental feeding
  3. Feeding or eating disorder other than ARFID
  4. Any comorbid clinically significant disorder that would require attention beyond the study treatment

6. Medical instability requiring inpatient care according to the American Psychiatric Association 2023 treatment guidelines for eating disorders 7. Medical history of intellectual disability 8. Illiteracy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: mCBT-AR
Behavioral: mCBT-AR
mCBT-AR is an 8-week virtual treatment for avoidant/restrictive food intake disorder delivered via mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)
Time Frame: Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)
The PARDI-AR-Q is a 32-item self-report measure based on the Pica, ARFID, and Rumination Disorder Interview that assesses ARFID diagnostic criteria and the presence and severity of each ARFID profile. Severity scores for each profile range from 0-6, with higher scores indicating greater severity.
Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)
Food Neophobia Scale (FNS)
Time Frame: Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)
The Food Neophobia Scale is a 6-item measure that measures reluctance to try new foods. Scores range from 7-42. Higher scores on the FNS are indicative of greater behavioral responses to novel foods.
Change from baseline (assessed at study entry) to final session, which occurs an average of eight weeks after baseline (measured at weekly study treatment sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P000075

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Avoidant/Restrictive Food Intake Disorder (ARFID)

Clinical Trials on mCBT-AR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe