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临床试验/NCT01337843
NCT01337843已完成2 期

Wellness Workbook: Efficacy of an Online CBT Workbook for Chronic Low Back Pain

Talaria, Inc2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
Talaria, Inc
入组人数
198
试验地点
2
主要终点
Lower pain related disability and interference scores.

研究概览

简要总结

This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). Participants will be randomly assigned to use the Wellness Workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability and pain severity.

详细描述

This research will evaluate the efficacy of a new online self- help intervention, the Wellness Workbook, for individuals with chronic low back pain (CLBP). The Wellness Workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (CBT) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the Wellness Workbook or alternative self-help materials for 10 weeks. Participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). Outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • currently experiencing chronic non-cancer pain in the lower back

排除标准

  • has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer)
  • does not have regular Internet access

结局指标

主要结局

Lower pain related disability and interference scores.

时间窗: Baseline, 10 weeks, 18 weeks

As compared to the control group participants, CLBP patients who use the WW intervention will report lower pain-related disability and lower pain interference scores.

次要结局

  • Fewer pain-related disabling beliefs and attitudes.(Baseline, 10 weeks, 18 weeks)

研究者

发起方
Talaria, Inc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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