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临床试验/NCT03800654
NCT03800654已完成不适用

Mindful Action for Pain: An Integrated Approach to Improve Chronic Pain Function

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2019年8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
126
试验地点
1
主要终点
Brief Pain Inventory (BPI) Pain Interference Subscale Change

研究概览

简要总结

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning.

This career development award (CDA-2) project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot randomized controlled trial (RCT) (n = 86) of MAP vs. cognitive behavioral therapy (CBT) for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

详细描述

Chronic pain, defined as persistent or episodic pain that does not resolve with treatment, affects up to 50% of Veterans, costs the nation between $560 and $635 billion dollars annually, and is associated with high rates of disability and low quality of life. According to the Veterans Health Administration (VHA), the goal of pain treatment is to improve physical and psychosocial functioning, emphasizing non-pharmacological approaches, such as psychosocial interventions, to target psychosocial factors that maintain disability. Unfortunately, the gold standard psychosocial intervention for chronic pain, Cognitive Behavioral Therapy (CBT), does not reliably produce meaningful increases in function.

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard CBT, but still falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning.

This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

Aim 1: Fully develop MAP in a population of Veterans with chronic pain (Phase 1).

Aim 2: Evaluate the feasibility of a future randomized efficacy trial of MAP vs. CBT-CP (Phase 2).

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosis of a chronic, non-terminal pain condition
  • Pain most days (> 3 days/week) for at least 6 months
  • Average pain severity and interference with enjoyment of life and/or general activity rated > 4/10 over the past week

排除标准

  • Serious or unstable medical or psychiatric illness
  • (e.g., unmanaged psychosis, manic episode, or substance abuse within the past year) or psychosocial instability
  • (e.g., homelessness) that could compromise study participation
  • Active suicidal ideation or history of suicide attempt within past 3 years
  • Current participation in group psychotherapy for pain or any type of individual psychotherapy
  • Changes to professionally delivered pain or mood treatments
  • (e.g., no discontinuation of a treatment; no increasing the dose of medication) one month preceding the baseline assessment.

研究组 & 干预措施

Mindful Action for Pain (MAP) Development

Other

In the first arm, MAP will be fully developed.

干预措施: Mindful Action for Pain (Behavioral)

MAP vs. CBT-CP

Active Comparator

In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.

干预措施: Mindful Action for Pain (Behavioral)

MAP vs. CBT-CP

Active Comparator

In the second arm, MAP will be compared to CBT-CP to establish feasibility of a larger, future trial.

干预措施: Cognitive Behavioral Therapy for Chronic Pain (Behavioral)

结局指标

主要结局

Brief Pain Inventory (BPI) Pain Interference Subscale Change

时间窗: Baseline and week 9

The BPI Pain Interference subscale consists of 7-items rated on a 0 - 10 scale that measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores are averaged with a range from 0 to 10. Higher scores indicate higher levels of pain interference (i.e., worse outcome).

次要结局

  • Chronic Pain Acceptance Questionnaire (CPAQ)(Baseline and week 9)
  • Mindfulness Attention Awareness Scale (MAAS)(Baseline and week 9)
  • Pain Catastrophizing Scale (PCS)(Baseline and week 9)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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