NCT05563649 Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
| NCT ID | NCT05563649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-03-17 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-03-17 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
With an incidence rate of about 1%, Anorexia Nervosa (AN) is a serious mental disorder associated with high mortality, morbidity, and cost. AN in youth is more responsive to early treatment but becomes highly resistant once it has taken an enduring course. The first-line treatment for adolescents with AN is Family Based Treatment (FBT). While FBT can be delivered using videoconferencing (FBT-V), therapists' limited availability hampers scalability. Guided self-help (GSH) versions of efficacious treatments have been used to scale and increase access to care. The main aim of this proposed comparative effectiveness study is to confirm that clinical improvements in GSH-FBT are achieved with greater efficiency than FBT-V in generalizable clinical settings.
Eligibility Criteria
Inclusion Criteria: 1. Participants are 12-18 years of age 2. Participants live with a family (some families may contain only one parent) 3. Family members fluently speak and read English and have access to a computer with internet 4. Participants meet DSM-5 criteria for AN (both subtypes) 5. EBW above 75% 6. Participants are medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine 7. Participants are not engaged in another individual or family-based psychotherapy trial during the duration of treatment sessions in the study. 8. Medications for comorbid psychiatric disorders are OK; randomization will balance groups through tracking. Exclusion Criteria: Current psychotic illness or intellectual disability or other mental illnesses that would prohibit the use of psychotherapy; current dependence on drugs or alcohol; physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight; previous FBT; and inability of the participant and/or family to speak and understand English.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05563649 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05563649 currently recruiting?
Yes, NCT05563649 is actively recruiting participants. Contact the research team at familytreatment@stanford.edu for enrollment information.
Where is the NCT05563649 trial being conducted?
This trial is being conducted at Stanford, United States, Hamilton, Canada.
Who is sponsoring the NCT05563649 clinical trial?
NCT05563649 is sponsored by Stanford University. The trial plans to enroll 200 participants.