基于正念的认知疗法的有效性在减少心理痛苦和改善炎症性肠道疾病患者的睡眠:多中心随机对照试验 (MindIBD) 的研究协议
Milou M Ter Avest1,2,3, Annelieke S M van Velthoven4,5, Anne E M Speckens4,5
1Department of Psychiatry, Centre for Mindfulness, Radboud University Medical Centre, Postbus 9101, Nijmegen, 6500 HB, the Netherlands. milou.teravest@radboudumc.nl.
基于正念的认知疗法 (MBCT) 可以改善炎症性肠病 (IBD) 患者的心理痛苦,睡眠和生活质量. 这项研究调查了MBCT.
科学领域:
- 胃肠道学和心理学
- 临床试验研究 临床试验研究
- 医疗保健服务研究 医疗服务研究
背景情况:
- 炎症性肠病 (IBD) 显著影响患者的心理健康,造成痛苦,疲劳和睡眠障碍,从而降低生活质量 (QoL) 并增加医疗保健成本.
- 目前对IBD患者的心理社会干预措施有限.
- 基于正念的认知疗法 (MBCT) 已在改善其他患者群体的心理痛苦,生活质量和睡眠方面表现出有效性.
研究的目的:
- 为了评估MBCT作为常规治疗 (TAU) 的辅助对IBD患者经历心理困扰的有效性.
- 评估MBCT对IBD患者的心理困扰,睡眠质量,疲劳,疾病活动,感知疾病控制,生活质量和积极心理健康的影响.
- 为了确定MBCT对IBD患者的成本效益.
主要方法:
- 一项前性,多中心,随机对照试验 (MindIBD研究) 涉及136名16岁及以上IBD患者,至少有轻度心理困扰 (HADS评分≥11).
- 参与者被随机分配到接受MBCT加TAU或单独TAU.
- 主要结局:减少心理困扰 (HADS评分). 二级结局包括睡眠质量 (动图,脑电图),疲劳,疾病活动,生活质量和心理健康,评估在基线和3,6,9和12个月.
主要成果:
- 这项研究旨在为MBCT的临床影响提供有价值的见解.
- 它将检查对患者报告的关键结果和客观措施的影响.
- 将进行成本效益和流程评估.
结论:
- 这项研究将提供关于MBCT对IBD患者心理困扰,睡眠,疲劳和QOL的疗效的关键数据.
- 如果证明有效,MBCT可以成为IBD心理社会护理的宝贵补充.
- 调查结果也可以为其他慢性疾病的干预提供信息.
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