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Challenges in Conducting a Multi-Site Randomized Clinical Trial Comparing Treatments for Adolescent Anorexia Nervosa INTERNATIONAL JOURNAL OF EATING DISORDERS Lock, J., Brandt, H., Woodside, B., Agras, S., Halmi, W. K., Johnson, C., Kaye, W., Wilfley, D. 2012; 45 (2): 202-213

Abstract

To describe obstacles in the implementation of a controlled treatment trial of adolescent anorexia nervosa (AN).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.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.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.

View details for DOI 10.1002/eat.20923

View details for Web of Science ID 000301228500005

View details for PubMedID 21495052

View details for PubMedCentralID PMC3140589