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Feasibility Study of a Digital Companion Treatment Program for Eating Disorders Added to Standard Outpatient Care

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Eating Disorders (Bulimia Nervosa, Anorexia Nervosa)
Date of first enrollment	20/04/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	Spoon DTx eating disorder treatment app (patient app + scaleless body weight scale) is used in addition to standard outpatient psychiatric care for 12 weeks. Patients use the app for educational material viewing, workbook exercises, and dietary behavior recording, while physicians review patient data via the physician app during clinic visits and provide feedback.

Outcome(s)

Primary Outcome

12-week continuation rate (proportion of participants who complete the assessment visit at 12 weeks after registration date [Day 85, allowable window Day 71-99])

Secondary Outcome

[Feasibility secondary indicators] Consent rate, enrollment rate, visit completion rate, questionnaire completion rate, missing data rate, app adherence indicators (weight measurement day rate, dietary behavior recording day rate, psychotherapy program completion rate), physician app viewing status, reasons for discontinuation [Safety outcomes] Incidence of adverse events and serious adverse events [Clinical outcomes] EDE-Q, weight, BMI, CIA, PHQ-9, GAD-7, EQ-5D-5L, frequency of binge eating episodes in the past 4 weeks [Usability and acceptability] SUS, CSQ-8J, subjective change in eating behavior (single item), intention to continue (single item)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients with DSM-5-TR diagnosis of bulimia nervosa or anorexia nervosa 2) Age 18 years or older 3) Any gender 4) Patients who have provided written informed consent voluntarily 5) Patients who have or can be provided smartphone access to use Spoon DTx throughout the study period 6) Patients whom the treating physician judges can be safely managed in an outpatient setting
Exclude criteria	1) BMI <16.5 kg/m2 or >40 kg/m2 2) Severe depressive episode per PHQ-9 and clinical examination 3) Imminent suicide risk per C-SSRS and clinical examination, or suicide attempt within the past 6 months 4) History of illicit drug use, or DSM-5-TR diagnosis of substance use disorder 5) Start, discontinuation, or dose change of antidepressants, antipsychotics, or anxiolytics within 4 weeks before study initiation 6) Currently receiving or planned for repetitive transcranial magnetic stimulation or electroconvulsive therapy 7) Currently receiving psychotherapy other than supportive psychotherapy 8) Pregnant or possibly pregnant 9) Patients deemed ineligible by the principal investigator or co-investigator