Eating Disorders (Bulimia Nervosa, Anorexia Nervosa) Eating disorders, Bulimia nervosa, Anorexia nervosa, Digital therapeutics, Feasibility
Conditions
Interventions
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 mater
Digital therapeutics, Smartphone application, Cognitive behavioral therapy
Sponsors
Kameya Masafumi
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: 1) BMI 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| [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) | — |
Contacts
Public ContactMasafumi Kameya
Kanazawa University Hospital
Outcome results
None listed