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临床试验/NCT03637699
NCT03637699已完成不适用

A Phase I Randomized Controlled Trial of a Positive Psychology Intervention for Patients With Multiple Sclerosis

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Percentage of PP Exercises Completed by Subjects

研究概览

简要总结

Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive emotional experiences such as positive affect. Examples of PP activities include recalling positive life events and performing acts of kindness. This pilot study will examine the tolerability and efficacy of a PP training program to increase positive affect in patients with multiple sclerosis (MS). In the intervention phase, subjects randomized to the intervention group will complete five weeks of PP exercises, one exercise per week. Subjects will also have weekly calls with the study trainer. The control group will have no study activities. In the extension phase, subjects in the control group will complete PP training as described above. The investigators will examine the tolerability of the program by calculating the proportion of subjects who complete the program. The investigators will also examine exercise-specific ratings of ease and utility to measure the acceptability of each exercise. Finally, the investigators will evaluate the efficacy of PP training by comparing subjects in the intervention and control groups on measures of positive affect, emotional function, health-related quality of life (HRQOL) and self-reported functional activities such as work. If successful, this study will advance the use of PP as a low cost, innovative and effective tool for increasing positive affect, decreasing depression and anxiety and improving HRQOL in patients with MS.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of multiple sclerosis according to the McDonald 2010 diagnostic criteria
  • Age 18-65
  • Ability to speak, read and write in English
  • Enrollment in the Comprehensive Longitudinal Investigation of Multiple Sclerosis at the Brigham and Women's Hospital, Partners MS Center: The CLIMB Study.

排除标准

  • Moderate or marked cognitive abnormalities on brief mental status testing identified that would preclude meaningful participation in the PP exercises.

结局指标

主要结局

Percentage of PP Exercises Completed by Subjects

时间窗: Five weeks

Measured by percentage of PP exercises completed by subjects.

次要结局

  • Change in Trait Optimism(Five weeks)
  • Changes in Affect(Five weeks)
  • Change in Depression(Five weeks)
  • Change in Anxiety(Five weeks)
  • Change in Resilience(Five weeks)
  • Subject Ratings of Ease of Completion of PP Exercises(Five weeks)
  • Change in Work Productivity(Five weeks)
  • Change in Perceived Stress(Five weeks)
  • Changes in Health-related Quality of Life(Five weeks)

研究者

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

Bonnie Ilene Glanz

Research Associate

Brigham and Women's Hospital

研究点 (2)

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