Not Yet RecruitingNot Applicable

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

60 participantsStarted 2025-04-01

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)

Timeframe: 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)

Timeframe: 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)

Trial details

NCT IDNCT06898177

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-04-01

Contact for this trial

Paraskevi Kambanis, PhD

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

View on ClinicalTrials.gov More Avoidant/Restrictive Food Intake Disorder (ARFID) trials

Plain-language summary

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pica, ARFID, and Rumination Disorder Interview - ARFID Questionnaire (PARDI-AR-Q)

Timeframe: 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)

Timeframe: 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)