Status:
ACTIVE_NOT_RECRUITING
Project HOME: Home-Based Treatment Options and Mechanisms for Eating Disorders
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Lifespan
Conditions:
Anorexia Nervosa
Eating Disorders
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This randomized, controlled effectiveness trial will assess outcomes, implementation, and mechanisms of two psychological treatments for adolescent anorexia nervosa (AN) delivered in the home setting,...
Detailed Description
Participants (adolescents with AN-spectrum and their parents) are asked to complete study assessments at 5 time points: baseline and 6-, 12-, 24-, and 32-weeks after starting treatment. The 32-week ti...
Eligibility Criteria
Inclusion
- Meets criteria for AN or atypical AN according to DSM-5 diagnostic criteria.
- Currently living at home with caregivers who are willing to engage in family treatment.
- Medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute) and receiving medical monitoring from a clinician throughout treatment.
- If on psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication for a co-morbid condition.
- Available for follow-up.
Exclusion
- Associated physical illness that necessitates hospitalization.
- Psychotic illness/other mental illness requiring hospitalization.
- Current dependence on drugs or alcohol.
- Physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight.
- Concurrent involvement in other psychological treatment for an eating disorder.
- Developmental delay that would preclude participation in the intervention.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05184556
Start Date
August 1 2022
End Date
April 30 2026
Last Update
December 10 2025
Active Locations (2)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
2
Gateway Healthcare
Pawtucket, Rhode Island, United States, 02860