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NCT Number: NCT06898177

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

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.

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Key information

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID) Avoidant Restrictive Food Intake Disorder Feeding and Eating Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mCBT-AR

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Xiang, BS

CONTACT

[email protected]

Paraskevi Kambanis, PhD

CONTACT

[email protected]

617-724-0799

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 27, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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