Adaptive Treatment for Adolescent Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097874
• Other study ID #: 1R01MH110538
• Secondary ID: SPO 1218591R01MH
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: October 5, 2022

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Potential subjects aged 12 to 18 with anorexia nervosa (AN) will be recruited from Stanford University, University of California, San Francisco, other bay-area medical programs and clinics, and online advertisement to the population at large. If participants are deemed eligible, participants will be invited for a baseline interview (about 2 hours in duration) during which the investigators will conduct interviews and collect questionnaire measures. Then, participants and participants' families will begin Family Based Treatment (FBT) with a study therapist at Stanford University or University of California, San Francisco, respectively. All assessments and treatments are conducted through tele-health. At session 4, if participants have not gained 2.4kg, an indicator of early treatment response, participants and participants' families will be randomized to receive either treatment as usual (FBT) or an adaptive form of FBT, during which families will receive additional Intensive Parental Coaching (IPC). If participants have reached weight milestones (i.e., 2.4kg at session 4), participants will continue FBT as usual. At 3 months of treatment and end of treatment, the investigators will collect the same measures taken at baseline. The investigators also ask that families participate in 6- and 12-month follow-up, respectively.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia in Adolescence
• Anorexia in Children
• Anorexia Nervosa
• Anorexia Nervosa Restricting Type
• Anorexia Nervosa, Atypical
• Eating Disorder
• Eating Disorders in Adolescence
• Feeding and Eating Disorders

Intervention

Behavioral:
• Family Based Treatment
Family Based Treatment of adolescent Anorexia Nervosa
• Family Based Treatment + Intensive Parental Coaching
Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University School of Medicine	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

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