NCT06898177 · Massachusetts General Hospital
Development and Testing of a Mobile App to Scale Delivery of Cognitive-behavioral Therapy for Avoidant/Restrictive Food Intake Disorder
What this study is about
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.
View original scientific description
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)
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)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations