针对青少年抑郁症和胰岛素抵抗的基于正念的干预:BREATHE的协议,一个多站点,试点和可行性随机对照试验
Natalia Sanchez1, Michele Chen2, Sally Ho3
1Department of Human Development and Family Studies, Colorado State University, USA.
Contemporary clinical trials
|April 5, 2024
概括
这项试点研究测试了2型糖尿病 (T2D) 风险青少年的正念干预. 该研究评估了可行性和可接受性,为改善抑郁症和胰岛素耐药性的更大试验做准备.
科学领域:
- 青少年健康 青少年健康
- 代谢障碍 代谢障碍 代谢障碍
- 心理健康干预措施 心理健康干预
背景情况:
- 抑郁症症状升高与青少年胰岛素抵抗性增加和2型糖尿病 (T2D) 风险增加有关.
- 基于正念的干预措施 (MBI) 显示出降低抑郁症和改善与胰岛素抵抗相关的生理因素的潜力.
- 在大规模疗效试验之前,多站点试点研究对于评估MBI可行性至关重要.
研究的目的:
- 评估六周MBI,认知行为疗法 (CBT) 和健康教育 (HealthEd) 组干预的多站点忠实性,可行性和可接受性.
- 为未来的多站点随机对照试验优化协议收集数据.
- 评估MBI在降低抑郁症和改善风险青少年胰岛素抵抗方面的潜力.
主要方法:
- 一个多站点,试点随机对照试验,涉及120名青少年 (年龄12-17岁) 患有肥胖和抑郁症状升高.
- 参与者在四个美国地点注册,并接受虚拟群体干预 (MBI,CBT或HealthEd).
- 评估是在基线,六周和一年进行的,以衡量结果.
主要成果:
- 主要结果集中在干预实施忠实度 (≥80%的坚持/能力) 和招聘可行性 (≥80%的入学率).
- 二次结果包括培训忠诚度,可行性,可接受性,招聘时间和留守.
- 结果将指导优化干预交付和评估,用于未来的试验.
结论:
- 这些发现将为未来多站点疗效随机对照试验的设计提供信息.
- 优化培训,招聘,干预交付,保留和评估协议是一个关键的结果.
- 这项研究支持为患T2D风险的青少年开发有效干预措施.
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