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临床试验/NCT04210466
NCT04210466Unknown不适用

COMP.ACT: Testing the Effect of Explicit Self-compassion Exercises in an ACT Group Intervention for Chronic Pain

University of Coimbra1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年1月7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
20
试验地点
1
主要终点
change from Pain Disability Index

研究概览

简要总结

This study tests the efficacy of adding explicit self-compassion meditation exercises in an ACT intervention for chronic pain (COMP.ACT). COMP.ACT is an 8-session, 2h each, psychological intervention for women with chronic pain. Half of participants will receive an ACT intervention + 2 Q&A sessions, and half of participants will receive an ACT intervention + 2 compassion-focused sessions with explicit self-compassion exercises.

详细描述

Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach, with empirical support in adapting to several chronic health conditions, such as chronic pain (CP), and its main purpose is to improve functioning and decrease interference of pain with valued life goals. Although the American Psychological Association (APA) has stated ACT as having empirical support in CP (http://www.div12.org/PsychologicalTreatments/treatments/chronicpain_act.html), with several studies showing its efficacy, there is still room for improvement. This might be attained by adding theoretically compatible components such as self-compassion. Although ACT has recently incorporated self-compassion as one of its outcomes, this has not been considered in any ACT intervention study for CP. Compassion-based approaches has been effective in targeting self-criticism, and has been effective in reducing a large array of psychopathological symptoms that are also common in CP (e.g. depression and anxiety). The current study aims to test the adding value of explicit self-compassion exercises in an ACT group intervention for CP.

General study design Participants previously diagnosed with CP by a physician will be assigned into two different conditions/groups: a group intervention for CP that includes explicit self-compassion exercises (COMP.ACT); and a group intervention that does not include explicit self-compassion exercises (ACT). The efficacy of COMP.ACT will be assessed by comparing it with the ACT condition.

Sample This study aims to focus on musculoskeletal CP as it is the most common cause of CP. Also, the study will recruit women with CP. Patients will be provided a study description, a consent form and the research team contact for further clarifications.

The COMP.ACT protocol has the following goals: (a) promote engagement in meaningful and effective activities, even with pain and distress, (b) improving present-focused awareness and acceptance of thoughts, feelings, and physiological sensations; (c) developing a self-compassion stance towards personal difficulties, and (d) promote commitment and engagement with valued actions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •chronic pain diagnosis(es),
  • •age between 18-65,
  • •residence in center region of Portugal,
  • •Availability to attend sessions.

排除标准

  • •Symptoms of psychosis,
  • •Non-suicidal self-injury,
  • •Suicide ideation,
  • •Severe Depression,
  • •Substance Abuse.

研究组 & 干预措施

Acceptance & Commitment Therapy + Compassion (COMP.ACT)

Experimental

an ACT intervention + 2 sessions of explicit self-compassion meditation exercises.

干预措施: Acceptance & Commitment Therapy + Compassion (COMP.ACT) (Behavioral)

Acceptance & Commitment Therapy (ACT)

Active Comparator

an ACT intervention + 2 Q&A sessions.

干预措施: Acceptance and Commitment Therapy (ACT) (Behavioral)

结局指标

主要结局

change from Pain Disability Index

时间窗: baseline, 2 months (post-intervention), 6 months (follow-up)

Pain disability - higher scores mean more pain disability

change from World Health Organization Quality of Life - Bref

时间窗: baseline, 2 months (post-intervention), 6 months (follow-up)

Quality of Life - higher scores mean more quality of life

change from Numeric Pain Rating Scale at 2 months (post-intervention)

时间窗: baseline, at 2 months (post-intervention)

Pain intensity - higher scores mean more pain intensity

change from Depression Anxiety and Stress Scale - 21 items

时间窗: baseline, 2 months (post-intervention), 6 months (follow-up)

Depression, anxiety and stress symptoms - higher scores mean more depression, anxiety and stress symptoms

次要结局

未报告次要终点

研究者

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

Sérgio Andrade Carvalho

Principal Investigator

University of Coimbra

研究点 (1)

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