Recruiting

Cognitive-Behavioral Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT06898177

Conditions

Avoidant/Restrictive Food Intake Disorder (ARFID)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

mCBT-AR

Study Details

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 ID

NCT06898177

Start date

Apr 13, 2026

Status verified date

Jun, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Apr 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mCBT-AR

no intervention: Usual care

Interventions

mCBT-AR

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Paraskevi Kambanis, PhD

617-724-0799pkambanis@mgh.harvard.edu

Jonathan Xiang, BS

jxiang2@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-16.