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OpenTrials
Completed

NCT Number: NCT03097874

Adaptive Treatment for Adolescent Anorexia Nervosa

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Family Based Treatment

Behavioral

Family Based Treatment of adolescent Anorexia Nervosa

Other names: Maudsley Method

Family Based Treatment + Intensive Parental Coaching

Behavioral

Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.

Other names: FBT + IPC

Primary outcomes

  1. Estimated Body Weight (EBW)

    Time frame: following 9 months of treatment

    individual with anorexia nervosa's body weight at end of treatment

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • National Institutes of Health (NIH)
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 31, 2017
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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