Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa

James Lock, Harry Brandt, Blake Woodside, Stewart Agras, W. Katherine Halmi, Craig Johnson, Walter Kaye, Denise Wilfley

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

Abstract

Objective: To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN). Method: The original aim was to enter 240 participants with AN to one of four cells: Behavioral family therapy (BFT) plus fluoxetine; BFT plus placebo; systems family therapy (SFT) plus fluoxetine; SFT plus placebo. Results: Recruitment was delayed pending a satisfactory resolution concerning participant safety. After 6 months of recruitment it became clear that the medication was associated with poor recruitment leading to a study redesign resulting in a comparison of two types of family therapy with a projected sample size of 160. One site was unable to recruit and was replaced. Discussion: Problems with the delineation of safety procedures, recruitment, re-design of the study, and replacement of a site, were the main elements resulting in a 1-year delay. Suggestions are made for overcoming such problems in future AN trials.

Original languageEnglish
Pages (from-to)202-213
Number of pages12
JournalInternational Journal of Eating Disorders
Volume45
Issue number2
DOIs
StatePublished - Mar 2012

Keywords

  • RIAN trial
  • adolescents
  • anorexia nervosa
  • behavioral family therapy
  • systems family therapy

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