Department of Child and Adolescent Psychiatry and Behavioral Sciences, Roberts Center for Pediatric Research, The Children's Hospital of Philadelphia, 2716 South Street, 8-212, Philadelphia, PA, USA.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
J Clin Psychol Med Settings. 2020 Jun;27(2):226-234. doi: 10.1007/s10880-020-09704-w.
We conducted a pilot randomized control trial (RCT) to simultaneously examine the feasibility of effectively implementing Cognitive Remediation Therapy (CRT) for adolescents with anorexia nervosa (AN) during medical hospitalization at a single-site hospital center. Employment of this protocol occurred on a general medical unit with diverse medical admitting diagnoses, not an eating disorder floor of a hospital and not part of a structured inpatient anorexia nervosa treatment program. This was the first time an RCT for a psychosocial intervention was implemented on this unit with patients with eating disorders. Here, we describe the process of piloting the study, including modifications that needed to be made to the original protocol. We also describe the feedback from major stakeholders regarding the process of conducting the pilot study. We summarize lessons learned and steps to take for smooth integration of an RCT of a therapeutic intervention on medical unit.Trial registration: ClinicalTrials.gov Identifier NCT02883413.
我们进行了一项初步的随机对照试验 (RCT),旨在同时检验在单一医院中心的医疗住院期间,为厌食症 (AN) 青少年有效实施认知修复治疗 (CRT) 的可行性。该方案是在一个具有多种医疗收治诊断的普通医疗病房中实施的,而不是在医院的饮食失调病房中实施,也不是在结构化的住院厌食症治疗计划中实施。这是首次在该病房为患有饮食障碍的患者实施心理社会干预的 RCT。在这里,我们描述了试验的试行过程,包括对原始方案进行的修改。我们还描述了主要利益相关者对试行研究过程的反馈。我们总结了经验教训以及在医疗单元上顺利整合治疗干预 RCT 所需采取的步骤。试验注册:ClinicalTrials.gov 标识符 NCT02883413。