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临床试验/NCT01595555
NCT01595555已完成不适用

Effectiveness of an Internet-based Mindfulness Program for Stress Management

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 684 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
684
试验地点
1
主要终点
Effect of SFN on vitality

研究概览

简要总结

This research will examine whether an Internet-based mindfulness program for stress management produced positive outcomes for participants and is technologically feasible

详细描述

Chronic, severe stress, a risk factor for premature aging and myocardial infarction, affects 35% of North Americans. Stress management programs, while effective, may be prohibitively resource intensive or difficult to access by broad populations.

This research is examining whether an online stress management program - Stress Free Now© (SFN) - can achieve meaningful improvements in measures of stress and wellbeing. We are also examining whether improvements in wellbeing and stress can be enhanced through an online, internet based support group which share experiences as they go through the Stress Free Now program. This program is modeled after an intensive group program, called Mindfulness Based Stress Reduction (MBSR), which has shown benefits across a broad array of medical issues in addition to more specific stress related problems.

This is a three arm randomized controlled trial which will last for 12 weeks. Participants will be randomized into one of the study arms: Non intervention Control, Stress Free Now and Stress Free Now + Message Board. We aim at enrolling 600 participants, with the expectation that 50% will complete the study (100 per group).

A series of questionnaires will be collected at baseline, at the end of the 8-week program and at follow up at week 12. Outcome measured are stress, mindfulness, vitality, physical, social and emotional health, transcendence and self-acceptance. We will also ask participants to complete a weekly log to measure program adherence and usage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 18 years or older
  • Sign-up for SFN (if in one of the intervention groups)
  • Agree to participate in the research
  • Have regular access to the internet

排除标准

  • 未提供

结局指标

主要结局

Effect of SFN on vitality

时间窗: End of intervention at week 8

Assess whether SFN improves vitality as measured by the Subjective Vitality Scale (SVS)

Effect of SFN on stress

时间窗: End of intervention at week 8

Assess whether SFN reduces stress as measured by the Perceived Stress Scale (PSS)

Effect of SFN on mindfulness

时间窗: End of intervention at week 8

Assess whether SFN improves mindfulness as measured by the Mindfulness Attention Awareness Scale (MAAS)

Effect of SFN on self acceptance

时间窗: End of intervention at week 8

Assess whether SFN improves self-acceptance as measured by the Psychological Well-being - Self-Acceptance Subscale (PWb-SA)

Effect of SFN on spirituality

时间窗: End of intervention at week 8

Assess whether SFN improves transcendence as measured by the Adult Self-Transcendence Inventory (ASTI)

次要结局

  • SFN effect on physical and mental health(End of intervention at week 8)
  • Assess program engagement and adherence(Through the 8-week program)
  • Assess whether adding Social Media to SFN improves engagement and outcome(Week 8 and 12)
  • Effect maintained at week 12 follow up(Week 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Linda Libertini

Research Coordinator

The Cleveland Clinic

研究点 (1)

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