stress reduction intervention in caregivers

一旦受试者被确定为计划在NIH临床中心接受同种异体HSCT的个体的主要护理者，则将其纳入本方案。在患者开始其移植预处理之前，接触患者和护理人员参与。需要至少78名护理人员的样本，以充分评估计划的主要分析的干预措施的有效性。 招募于2015年1月开始，由于入组人数减少，研究于2019年1月关闭招募。共筛选了232例受试者的合格性，其中56例受试者在随机化前来自研究。受试者被随机分配到一个为期六周的音频文件瑜伽为基础的减压干预组（N=25），或教育对照组（N=25）。护理者受试者在两个时间点（TP）完成问卷：入组基线（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例受试者完成研究。在登记的56例受试者中，6例受试者退出。数据收集于二零一九年二月完成。该研究目前已关闭招募，但开放进行数据分析。

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.