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

NCT06898177 | Not Yet Recruiting

• 1 other identifier: 2025P000075
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Outcome Measures

Primary Outcomes (2)

• Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)

  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)

  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)

Study Arms (2)

mCBT-AR

EXPERIMENTAL

Behavioral: mCBT-AR

Usual care

NO INTERVENTION

Interventions

mCBT-AR BEHAVIORAL

mCBT-AR is an 8-week virtual treatment for avoidant/restrictive food intake disorder delivered via mobile application

mCBT-AR

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Avoidant Restrictive Food Intake Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Paraskevi Kambanis, PhD

CONTACT

617-724-0799; pkambanis@mgh.harvard.edu

Lily Palmer, BA

CONTACT

617-724-0799; lpalmer6@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: April 4, 2025

Record last verified: 2025-04