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

NCT ID: NCT06898177

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2030-04-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mCBT-AR

Group Type: EXPERIMENTAL

mCBT-AR

Intervention Type: BEHAVIORAL

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

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mCBT-AR

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paraskevi E. Kambanis

Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Paraskevi Kambanis, PhD

Role: CONTACT

pkambanis@mgh.harvard.edu

617-724-0799

Lily Palmer, BA

Role: CONTACT

lpalmer6@mgh.harvard.edu

617-724-0799

Other Identifiers

2025P000075

Identifier Type: -

Identifier Source: org_study_id