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临床试验/NCT03924687
NCT03924687已完成不适用

A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Université du Québec à Trois-Rivières0 个研究点目标入组 140 人开始时间: 2016年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
主要终点
Change in Pain-related disability

研究概览

简要总结

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility.

The current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on ACT, in the management of chronic pain.

This study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). Participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

详细描述

The purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on Acceptance and Commitment Therapy with minimal therapeutic support in the management of chronic pain.

This study was based on the following hypotheses. In comparison to the control group, from pre to post, the self-help program will:

  1. significantly reduce pain-related disability (primary variable);
  2. improve depressive symptoms related to CP (secondary variable);
  3. increase the level of pain acceptance;
  4. reduce psychological inflexibility linked to painful symptoms (process variables).

It was also expected that: 5. the improvements would be maintained at three-month follow-up; 6. participants would have an overall impression of a positive change following the intervention.

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

  • being 18 years of age or older
  • having suffered from daily pain for more than three months
  • having reading and writing abilities in French equivalent or superior to grade 8
  • having access to Internet at home and having a valid e-mail address
  • not having previously completed an ACT-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on ACT for pain
  • having stable medication for at least one month, if applicable.

排除标准

  • 未提供

研究组 & 干预措施

control group

No Intervention

Wait-list control condition: participants placed on a wait-list (and receiving the intervention following the 9 week duration of the intervention)

ACT group

Experimental

ACT group: participants receiving the 8-week bibliotherapy intervention based on Acceptance and Commitment Therapy

干预措施: Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain (Behavioral)

结局指标

主要结局

Change in Pain-related disability

时间窗: Change from week 9 and week 21 (ACT group only)

Brief Pain Inventory (BPI; Interference subscale; Cleeland \& Ryan 1994; Poundja, Fikretoglu, Guay, \& Brunet 2007; Tyler, Jensen, Engel, \& Schwartz 2002)

次要结局

  • Change in Pain acceptance(Change from week 9 and week 21 (ACT group only))
  • Change in Psychological inflexibility(Change from week 9 and week 21 (ACT group only))
  • Change in Depressive symptoms(Change from week 9 and week 21 (ACT group only))
  • Participants' impression of change(week 21)

研究者

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

Dr. Frédérick Dionne, Ph.D.

Associate Professor

Université du Québec à Trois-Rivières

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