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临床试验/NCT04790162
NCT04790162Unknown不适用

Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program (HEART)

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)

研究概览

简要总结

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students. It is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. It is also hypothesized that those students who participate in the meditation program will increase resilience.

详细描述

This investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day Heartfulness Practice delivered virtually for health care students.

SPECIFIC AIMS (SA) SA1: Determine feasibility and acceptability of delivering the 90-day Heartfulness Meditation Program virtually. Feasibility will be assessed by participant compliance, retention, and acceptability to the participants.

Criteria: Feasibility will be achieved by Compliance with average of at least 3 trainer led meditations / week Retention of 75% of participants at the end of 45 days (intermediate point) and 90 days (primary end point).

Criterion: Acceptability will be indicated by a CSQ8 score > 17. SA2: Examine the benefits of Heartfulness meditation on improving resilience, decreasing depression, and decreasing anxiety of health care students.

H2: At the end of 90 days (primary end point), students who participate in the Heartfulness Resilience Training (HEART) will have better resilience (CD-RISC) compared with students who do not participate and will have less anxiety and depression (HADS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ages 20-70
  • Student in one of the health care programs on the Anschutz Medical Campus at the University of Colorado.

排除标准

  • Students who are currently engaged in any formal meditation practice (e.g., Transcendental Meditation, Mindfulness Based Stress Reduction, (MBSR) more than once per week
  • Unable to use the technology without special accommodations.

结局指标

主要结局

Acceptability as measured by the Client Satisfaction Questionnaire (CSQ-8)

时间窗: 45 days, 90 days

8-item measure of satisfaction that is rated on a 4-point Likert scale and has a score range from 8 to 32. Higher scores indicate greater levels of satisfaction. For this study, we will assign 3 levels of satisfaction: 1) dissatisfied or least satisfied (score 8-16); 2) satisfied (score 17-30); and 3) very satisfied (score 31-32)The CSQ-8 has good test-retest reliability, internal consistency and sensitivity to treatment

Change in Resilience as measured by Connor-Davidson Resilience Scale (CD-RISC)

时间窗: Baseline, 45 days, 90 days

25 item self-report questionnaire developed to quantify resilience and the impact of psychoeducation and resilience therapy techniques. Total scores range from 0-100 with higher scores indicating greater levels of resilience. The CD-RISC has been used in a variety of populations.

Change in Anxiety/Depression as measured by the Hospital Anxiety and Depression Scale (HADS)

时间窗: Baseline, 45 days, 90 days

14-item screening scale developed to indicate the potential presence of anxiety and depression. HADS consists of a 7-item anxiety subscale and a 7-item depression subscale. The HADS has good validity and reliability and has been studied in a variety of populations

Feasibility as measured by the Number of Meditation Sessions Completed

时间窗: 90 days

Number of Meditation Sessions Completed-logged in RedCap

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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