在功能性消化不良的背景下,避免/限制性食物摄入障碍的简要认知行为治疗:为可行性随机对照试验的研究方案
Helen Burton Murray1, Brjánn Ljótsson2, Brian Healy3
1Harvard Medical School, Boston, MA, USA; Multidisciplinary Eating Disorders Research Collaborative, Mass General Brigham, Boston, MA, USA; Division of Gastroenterology, Massachusetts General Hospital, Boston, MA, USA.
Contemporary clinical trials
|September 18, 2023
概括
这项研究评估了针对功能性消化不良和避免/限制性食物摄入障碍 (ARFID) 的成年人进行基于暴露的八次认知行为治疗 (CBT) 的可行性. 这些发现将为这些常见的肠-大脑相互作用障碍的未来治疗开发提供指导.
科学领域:
- 胃肠病学 胃肠病学
- 精神病学是一个精神病学.
- 行为科学 行为科学
背景情况:
- 避免/限制性食物摄入障碍 (ARFID) 症状影响高达40%的功能性消化不良 (FD) 的成年人.
- FD是一种肠-大脑相互作用障碍,表现为早期的和,和腹部不适.
- FD和ARFID的同时出现是一个重大的临床挑战.
研究的目的:
- 确定对患有FD和ARFID的成年人进行基于暴露的8次认知行为治疗 (CBT) 的可行性.
- 评估临床结果的变化,包括症状严重程度和生活质量.
- 探索治疗有效性的潜在作用机制.
主要方法:
- 一个随机对照试验比较CBT加常规护理 (UC) 单独UC在50名患有FD和ARFID的成年人 (≥5%的体重减轻).
- 主要可行性基准包括入学率,评估完成率,会议出席率和客户满意度.
- 二次结果包括评估FD症状严重程度,生活质量和潜在的作用机制的变化.
主要成果:
- 将评估可行性基准,包括参与者招生,治疗坚持和评估完成率.
- 功能性消化不良症状严重程度和生活质量的变化将在组内和组之间进行分析.
- 探索性分析将调查潜在的治疗效应背后的潜在机制.
结论:
- 结果将为FD+ARFID的CBT的改进提供信息.
- 结果将指导未来的设计,全功率的疗效试验.
- 这项研究旨在改善FD和ARFID同时发生的个体的治疗选择.
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