Anorexia Nervosa Clinical Trial
Official title:
Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
Verified date | October 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are conducting a randomized controlled trial using an adaptive design for adolescents (ages 12-18) with anorexia nervosa to compare standard Family Based Treatment (FBT) to adaptive FBT with an Intensive Parental Coaching (IPC) component. If participants do not reach expected milestones by session 4 of treatment, participants may be randomized to receive additional IPC or continue treatment as usual with regular FBT.
Status | Completed |
Enrollment | 130 |
Est. completion date | October 5, 2022 |
Est. primary completion date | October 5, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - 12-18 years of age and living with participants' families - meeting DSM-5 criteria for AN (both subtypes) except for the amenorrhea requirement - medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine. Exclusion Criteria: - associated physical illness that necessitates hospitalization - psychotic illness, mental retardation, or any 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 - currently taking medication for co-morbid disorders that cannot be safely discontinued on a stable dose for less than 2 months - in the case of patients with current, or a history of sexual or physical abuse by family members, perpetrators of the abuse will be excluded from treatment. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimated Body Weight (EBW) | individual with anorexia nervosa's body weight at end of treatment | following 9 months of treatment |
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