stress reduction intervention in caregivers

受试者一旦被确定为计划在美国国立卫生研究院临床中心接受异基因造血干细胞移植的个人的主要照顾者，就会被纳入这一方案。在患者开始移植调理之前，患者和照顾者(S)被要求参与。需要对至少78名照顾者进行抽样，以充分评估干预措施的有效性，以便进行计划中的初步分析。 招聘于2015年1月开始，由于登记人数减少，这项研究于2019年1月结束。共有232名受试者接受了资格筛选，其中56名受试者来自随机分组前的研究。受试者被随机分配到为期六周的基于音频文件瑜伽的减压干预组(N=25)，或教育对照组(N=25)。照顾者在两个时间点(TPS)完成问卷调查：基线(TP#1，干预组N=25；对照组N=25)和基线后6周(TP#2，干预组N=22，对照组N=23)，50名受试者完成研究。在登记的56名受试者中，有6名受试者退出。数据收集工作于2019年2月完成。这项研究目前对权责发生制不开放，但对数据分析开放。

Subjects were accrued to this protocol once they were identified as serving as a primary caregiver for an individual planning to undergo an allogeneic HSCT at the Clinical Center, NIH. The patient and caregiver(s) were approached for participation before the patient started their transplant conditioning. A sample of at least 78 caregivers was needed to adequately evaluate the effectiveness of the intervention for the planned primary analysis. Recruitment began in January 2015, and the study was closed to accrual in January 2019 due to a decrease in enrollment numbers. A total of 232 subjects were screened for eligibility, 56 subjects from the study prior to randomization. Subjects were randomly assigned to a six-week audio file yoga-based stress reduction intervention group (N=25), or an education control group (N=25). Caregiver subjects completed the questionnaire at two-time points (TPs): baseline (TP#1 the intervention arm N=25; the control arm N=25) and six weeks after baseline (TP#2 the intervention arm N=22; the control arm N=23) were enrolled, and 50 subjects have completed the study. Of the 56 subjects registered, 6 subjects withdrew. Data collection was completed in February 2019. The study currently is closed to accrual but open for data analysis.