Clinical trial NCT03097874: Adaptive Treatment for Adolescent Anorexia Nervosa
Official title: Confirming the Efficacy/Mechanism of an Adaptive Treatment for Adolescent Anorexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Anorexia
Anorexia Nervosa
Anorexia in Adolescence
Anorexia in Children
Anorexia Nervosa Restricting Type
Anorexia Nervosa, Atypical
Eating Disorders in Adolescence
Keywords: anorexia
anorexia nervosa
eating disorder
weight
eating
weight loss
family based treatment
FBT
family treatment
therapy
Maudsley method
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2017-03-31
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated Body Weight (EBW)
timeFrame: following 9 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
citation: L'Insalata A, Trainor C, Bohon C, Mondal S, Le Grange D, Lock J. Confirming the Efficacy of an Adaptive Component to Family-Based Treatment for Adolescent Anorexia Nervosa: Study Protocol for a Randomized Controlled Trial. Front Psychiatry. 2020 Feb 12;11:41. doi: 10.3389/fpsyt.2020.00041. eCollection 2020.