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临床试验/NCT03471637
NCT03471637已完成不适用

How do Self-compassion and Psychological Flexibility Mediate Change in a Compassion-Focused Therapy Group for Chronic Pain?

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2018年2月27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
122
试验地点
2
主要终点
Strength of Self-Compassion as a mediator at Week 11

研究概览

简要总结

This research aims to study how Compassion-Focused Therapy (CFT) might work for people with chronic pain. People with chronic pain may feel shameful about their condition and this type of therapy aims to help people to view themselves and their difficulties in a kinder, less critical way (i.e. self-compassion). Currently, no research is available on the effectiveness of CFT in helping people with chronic pain.

Participants attending a CFT-incorporated Pain Management Programme will complete a battery of questionnaires at the start of the group (week 1), in the middle of the group (week 5) and at the end of the group (week 11).

详细描述

Pain Management Programmes help people to manage their pain and improve quality of life, and this research will look into the processes by which this happens. This study will look at two psychological concepts: 'self-compassion' (kindness to self) and 'psychological flexibility' (willingness to tolerate difficult experiences in order to meet meaningful goals). These concepts help in understanding how people think about themselves in the context of pain.

Principle Research Question: Do self-compassion and psychological flexibility mediate change (anxiety/depression/well-being) in a Compassion-Focused Therapy group for adults with chronic pain?

Primary Outcome Measure: Strength of mediation effects

Sample Size:

[Reference 1] propose guidelines for recommended sample sizes in order to detect mediation effects with .8 power. These guidelines are informed by existing literature in the field. There is less robust research on self-compassion and chronic pain, therefore, this calculation is based on research in psychological flexibility and chronic pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

  • Fluency of English sufficient for participation in the group and completion of questionnaires
  • Aged 18+ (no upper age limit)
  • Ability to provide informed consent (as defined by the Five Statutory Principles of the Mental Capacity Act, Code of Practice, 2007)

排除标准

  • Active substance misuse
  • Active suicidality
  • Terminal illness
  • Inability to provide informed consent

结局指标

主要结局

Strength of Self-Compassion as a mediator at Week 11

时间窗: Week 1

Strength of Psychological Flexibility as a mediator at Week 11

时间窗: Week 1

次要结局

  • Self-Compassion Scale (short form, SCS-SF; Neff, 2003)([Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy])
  • The Brief Pain Inventory (short form, BPI-SF; Cleeland & Ryan, 1994)([Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy])
  • Multi-Dimensional Psychological Flexibility Inventory (short form, MPFI-SF; Rolffs et al., 2016)([Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy])
  • The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) (Tennant et al., 2007)([Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy])
  • The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)([Time Frame: Week 1 (start), Week 5 (middle) and Week 11 (end) of group therapy])

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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