Development and testing of a mobile app to scale delivery of cognitive- behavioral therapy for avoidant/restrictive food intake disorder

/ABSTRACT Avoidant/restrictive food intake disorder (ARFID) is a severe and impairing eating disorder, affecting up to 4% of adults, characterized by food avoidance and restrictive eating motivated by sensory sensitivities, fear of aversive consequences of eating, and/or lack of interest in eating or food. Individuals with ARFID are at risk for serious health consequences. Cognitive-behavioral therapy for ARFID (CBT-AR) is a brief behavioral treatment for ARFID that has demonstrated evidence of feasibility, acceptability, and proof-of-concept. However, most individuals with ARFID do not have access to CBT-AR. Barriers to treatment access (e.g., cost, location) contribute to estimates that less than 25% of individuals with psychiatric disorders in need of treatment seek help. Further, the prevalence of psychiatric conditions worldwide—including ARFID—far exceeds the current capacity of mental health providers and services required. Digital mental health treatments (DMHTs), including mobile applications (“apps”), provide an efficacious, cost-effective, and scalable method for extending the reach of mental health care. Approximately 97% of American adults own a smartphone, further highlighting the utility of DMHTs as a promising avenue to increase access to healthcare resources. This proposal develops and tests a mobile app to deliver CBT-AR (mCBT-AR). I propose to: (a) utilize an iterative approach to developing mCBT- AR, implementing user-centered design principles; and (b) test the feasibility, acceptability, and proof-of-concept of mCBT-AR. My findings will fill a critical area in the necessity of a clinically effective, accessible, scalable, and inexpensive treatment for ARFID. In collaboration with my primary mentor (Dr. Thomas), co-mentors (Drs. Wilhelm and Fitzsimmons-Craft), and expert collaborators (Drs. Burton-Murray and Tabri, Mr. Landheim), I have developed a comprehensive training plan that will prepare me with the requisite skills and training needed to establish myself as a clinical investigator focused on increasing access to treatment for ARFID and other eating disorders through digital mental health treatments. My K23 training and career development goals are to: (1) gain expertise in digital mental health treatment development; (2) enhance my knowledge of symptom change and treatment response in ARFID; (3) establish skills in the design and analysis of brief interventions and randomized controlled trials; and (4) achieve independence in career development and the responsible conduct of research. Together, these goals will provide me with the necessary skills to transition to a career as an independent investigator, setting the stage for conducting R-level clinical trials. The proposed research will contribute to the development of a clinically accessible, scalable, inexpensive treatment for ARFID, a highly impairing disorder for which most individuals lack access to treatment. The mentored training will inform my preparation of a R01 grant application to conduct a larger randomized controlled trial of mCBT-AR, using a micro- randomized or adaptive design, to prepare for large-scale dissemination of the intervention to improve the lives of individuals living with ARFID. Project Number: 1K23MH139989-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Paraskevi Kambanis | Institution: MASSACHUSETTS GENERAL HOSPITAL, BOSTON, MA | Award Amount: $197,400 | Activity Code: K23 | Study Section: Effectiveness of Mental Health Interventions Study Section[EMHI] View on NIH RePORTER: https://reporter.nih.gov/project-details/11114413