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Challenges in conducting a multi‐site randomized clinical trial comparing treatments for adolescent anorexia nervosa
Author(s) -
Lock James,
Brandt Harry,
Woodside Blake,
Agras Stewart,
Halmi W. Katherine,
Johnson Craig,
Kaye Walter,
Wilfley Denise
Publication year - 2012
Publication title -
international journal of eating disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.785
H-Index - 138
eISSN - 1098-108X
pISSN - 0276-3478
DOI - 10.1002/eat.20923
Subject(s) - anorexia nervosa , fluoxetine , placebo , psychology , family therapy , clinical trial , randomized controlled trial , psychiatry , eating disorders , psychotherapist , clinical psychology , medicine , alternative medicine , receptor , pathology , serotonin
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. © 2011 by Wiley Periodicals, Inc. (Int J Eat Disord 2012)