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临床试验/NCT03077971
NCT03077971Unknown不适用

Effectiveness of Acceptance and Commitment Therapy Self-Help for Carers of People With Multiple Sclerosis: A Feasibility Randomised Controlled Trial

University of Nottingham1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
ZBI

研究概览

简要总结

This is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with MS is effective in reducing carer strain. Whilst not all carers experience distress as a result of their caring duties, some do. This study is testing the use of Acceptance and Commitment Therapy (ACT) in a self-help format. Participants will learn about and use ACT by reading a book provided to them by the study. One group will receive the ACT book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. Participants are allocated to the groups based on chance (a computer will decide group allocation). Participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. Those who receive the self-help book will get sent chapters each week for 8 weeks. The groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •primary carer for a person with MS,
  • •English speaking (intervention and assessments are in English),
  • •able to give informed consent.
  • •score at least 21 on the Zarit Burden Interview (demonstrating a minimum of mild distress)

排除标准

  • •diagnosis of MS themselves
  • •psychiatric diagnosis
  • •inability to commit to the intervention

研究组 & 干预措施

ACT Self-Help

Experimental

Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks.

干预措施: ACT Self-Help (Behavioral)

ACT Self-Help with Telephone Support

Experimental

Participants in this arm will receive a self-help book based on Acceptance and Commitment Therapy (ACT). Participants will receive chapters each week, either electronically or by post, for 8 weeks. In addition to this, participants will have weekly telephone calls to support the use of the book.

干预措施: ACT Self-Help with Telephone Support (Behavioral)

Treatment As Usual

No Intervention

Participants in this arm will have no intervention as part of the trial.

结局指标

主要结局

ZBI

时间窗: 3 months

Zarit Burden Interview as a measure of carer strain

次要结局

  • MCSI(3 months, 6 months)
  • CAREQOL-MS(3 months, 6 months)
  • ZBI(6 months)
  • CompACT(3 months, 6 months)
  • AAQ-II(3 months, 6 months)
  • Service Use Questionnaire(3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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