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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06898177
Enrollment
60
Registered
2025-03-27
Start date
2026-04-13
Completion date
2030-04-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

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.

Interventions

BEHAVIORALmCBT-AR

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)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.
Food Neophobia Scale (FNS)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.

Countries

United States

Contacts

CONTACTParaskevi Kambanis, PhD
pkambanis@mgh.harvard.edu617-724-0799
CONTACTJonathan Xiang, BS
jxiang2@mgh.harvard.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026