臨床研究等提出・公開システム

Date of registration	April. 20, 2026
Last modified on	April. 20, 2026
Trial ID	jRCT1040260010

Scientific Title	Feasibility Study of a Digital Companion Treatment Program for Eating Disorders Added to Standard Outpatient Care (Spoon DTx Feasibility Trial)
Public Title	Feasibility Study of a Digital Companion Treatment Program for Eating Disorders Added to Standard Outpatient Care (Spoon DTx Feasibility Study)

Contact for Scientific Queries	Name	Kameya Masafumi
	Affiliation	Kanazawa University Hospital
	Address	13-1 Takaramachi, Kanazawa, Ishikawa 920-8641
	Telephone	+81-76-265-2307
	E-mail	mkame@med.kanazawa-u.ac.jp
Contact for Public Queries	Name	Kameya Masafumi
	Affiliation	Kanazawa University Hospital
	Address	13-1 Takaramachi, Kanazawa, Ishikawa 920-8641
	Telephone	+81-76-265-2307
	E-mail	mkame@med.kanazawa-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 20, 2026
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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
	Exclusion 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Eating Disorders (Bulimia Nervosa, Anorexia Nervosa)
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.
Health Condition(s) Keyword		Eating disorders, Bulimia nervosa, Anorexia nervosa, Digital therapeutics, Feasibility
Intervention(s) Keyword		Digital therapeutics, Smartphone application, Cognitive behavioral therapy
Primary Outcome(s)		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(s)		[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)

Primary Sponsor	Department of Neuropsychiatry, Kanazawa University Hospital

Source of Monetary Support	Japan Agency for Medical Research and Development (AMED) Translational Research Program Seed A (Tohoku University Hospital Clinical Research Promotion Center [CRIETO], Grant Number JP25ym0126802); Kanazawa University Hospital 2025 Competitive Research Fund (Seed B)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Trial Review Board of Kanazawa University Hospital
Address	13-1, Takara-machi, Kanazawa-city, Ishikawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 23, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none