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Recruiting NCT06898177

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

No phase Interventional Avoidant/Restrictive Food Intake Disorder (ARFID)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: mCBT-AR.
Who it may be relevant to
Registry conditions: Avoidant/Restrictive Food Intake Disorder (ARFID). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • 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)]
  • 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)]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT06898177 · 2025P000075

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗