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Challenges in conducting a multi-site randomized clinical trial comparing treatments for adolescent anorexia nervosa.
- Source :
- International Journal of Eating Disorders; Mar2012, Vol. 45 Issue 2, p202-213, 12p, 5 Charts, 1 Graph
- Publication Year :
- 2012
-
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. © 2011 by Wiley Periodicals, Inc. (Int J Eat Disord 2012) [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 02763478
- Volume :
- 45
- Issue :
- 2
- Database :
- Complementary Index
- Journal :
- International Journal of Eating Disorders
- Publication Type :
- Academic Journal
- Accession number :
- 71285720
- Full Text :
- https://doi.org/10.1002/eat.20923