stress reduction intervention in caregivers

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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.