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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • mCBT-AR

    Behavioral

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: mCBT-ARExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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.

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)
2

Food Neophobia Scale (FNS)

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.

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

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