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Completed

NCT Number: NCT01579682

Adaptive Family Treatment for Adolescent Anorexia Nervosa

Anorexia Nervosa (AN) has the highest mortality rate compared to any other psychiatric disorder. The most promising treatment for adolescents with AN is family-based treatment (FBT). However, only 50% of patients receiving FBT fully remit at 12-month follow-up. Consequently, providing an alternative therapy early in the treatment course for those not responding to FBT may enhance overall outcome. This study aims to develop a new treatment - Intensive Family-Focused Treatment (IFT) - to improve outcomes in those adolescents, aged 12-18 years, who do not show an early response to FBT.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meets DSM-IV criteria for anorexia nervosa
  • Lives with at least one English-speaking parent who is willing to participate
  • Medically Stable
  • Adequate transportation to clinic
  • Proficient at speaking, reading, and writing English

Exclusion criteria

  • Previous FBT for AN
  • Medical condition that may affect eating or weight

Treatment and study plan

Family-Based Therapy (FBT)

Behavioral

12 sessions of FBT over the course of 6 months.

Family-Based Therapy with Intensive Family-Focused treatment

Behavioral

FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.

Primary outcomes

  1. Full remission from AN (%MBW>95)

    Time frame: End of Treatment (6 months)

    Weight restoration to at least 95% of Median body weight (calculated by height, weight, gender, and age)

Secondary outcomes

  1. Changes in subscale scores of the EDE

    Time frame: End of Treatment (6 months)

    Eating Disorder Examination subscale measures (weight concern, shape concern, dietary restraint) within 1 standard deviation of normative scores.

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Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of Chicago

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Apr 18, 2012
Registry last updated
Apr 13, 2016

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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