Differential Contributions of Online Stress and Pain-explicit Mindfulness Treatment Groups to Processes, Patient Experience and Outcomes in Chronic Pain: A Randomized Controlled Trial and Qualitative Analysis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 1a: Pain Acceptance utilisikng the 8-item Chronic Pain Acceptance Questionnaire
研究概览
简要总结
Mindfulness is a popular set of knowledge and practical techniques that can help people cope with stress. It includes meditation practices, everyday small practices to break and change usual habits, as well as understanding and developing competencies to be more aware of thoughts, emotions and physical sensations. Mindfulness can help not to excessively react to them, or becoming distressed by these, as well as pain.
In persistent pain (pain that lasts more than three months), mindfulness is thought to improve depression, quality of life, and even how sore people feel.
There are numerous versions of mindfulness and mindfulness-based therapies. One approach, Acceptance and Commitment Therapy (ACT), is based on science (as opposed to religion or common sense). ACT helps people to learn about and apply skills to cope with thoughts, emotions and sensations without getting upset, distracted or impeded by them. It also assists people to develop the ability to set clear goals that matter in their life. ACT evaluates successful outcomes in this areas (called 'processes') and how these link to changes in pain, mood and stress. However, more puritan mindfulness courses tend to only focus on the latter.
Research on mindfulness courses for chronic pain, can show that people improve, but not so well what changes in people's experience and skills, or how such skills are applied. The investigators also know that pain sufferers who attend mindfulness courses for stress, may say it is not so relevant to their pain difficulties.
In this study the investigators want to explore how both mindfulness for stress and mindfulness for pain courses, online, contribute to:
- How specific areas of ACT and other mindfulness learning change
- If/how these link with practical skills and any emotional or improvements in the participants' quality of life, use of medication or GP visits.
- If/how the above correlate with physiological stress responses such a heart rate variability To help us evaluate this, the investigators will ask participants to complete scientifically accepted questionnaires and interview a proportion of participants. Some may be invited to wear portable heart rate monitors. The investigators will then use statistical methods and qualitative methods to evaluate change.
This may help us with better supporting chronic pain sufferers with choices around mindfulness as a standalone or as part of attending intensive pain-coping programmes involving different professions.
详细描述
Detailed Description
Mindfulness can be defined operationally as Paying attention; on purpose in the present moment and non-judgmentally.
Evidence-based (often referred to as 'secular') mindfulness has seen an exponentially increasing interest in the scientific literature and the estimated number of published scientific journals has recently been reported to have grown from one single journal in 1982, to 667 scientific publications in 2016 and in excess of 30,000 Media Pieces in Newspapers.
However, there are unknowns around the mechanisms (the 'vehicles' of change) by which mindfulness works. These must be better understood in order to avoid continued professional and public misinformation, poor research and ultimately, potential harm to the end user. (Van Dam, van Vugt et al. 2018).
ISSUES WITH AND IMPLICATIONS OF WHAT THE INVESTIGATORS CURRENTLY DEFINE AS MINDFULNESS AND ITS APPLICATION TO CHRONIC PAIN
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 (Outcomes Assessor)
盲法说明
The data analysis will be performed blind by one of the researchers - after data has been anonymised and transferred.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 1a: Pain Acceptance utilisikng the 8-item Chronic Pain Acceptance Questionnaire
时间窗: baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention
This will be utilised to measure and track the patient's changes (if any) - at relevant at each time point in the study - with acceptance of pain. Assessed by Likert Scale on multiple items (0 = Never true; 6 = always true).
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 2: Contact with the Present Moment: The Mindful Attention Awareness Scale will be utilised.
时间窗: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
This will be utilised to track and measure the patient's changes (if any) - at each time point in the study - of mindful attention and awareness. Assessed by Liker Scale on multiple items (1 = Almost Always; 6 = Almost Never)
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 5: Values: The Chronic Pain Values Inventory
时间窗: baseline, pre-intervention, during intervention, immediately after intervention, 3 months after the intervention
This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - with how able they are to notice what matters in their life and their discrepancy with / from it. Assessed via Likert scale on importance/success 0 - 5 (0 = not at all important/successful; 5 = extremely important/successful)
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 3: Self in context: The Self Experience Questionnaire will be utlised.
时间窗: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
This measure will be utilised to track and measure the changes (if any) - at each time point in the study - of patient's ability to observe themselves as separate from triggering processes. Assessed by Likert Scale on multiple items (0 = never true; 6 = always true)
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 6: Committed Action: The 8-item Committed Action Questionnaire
时间窗: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - their ability to commit to valuable behaviours. Assessed by likert scale on multiple items (0 = Never True; 6 = always true)
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 4: Cognitive fusion: the Cognitive Fusion Questionnaire
时间窗: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
This will be utilised to measure and track the patient's changes (if any) - at each time point in the study - with how entangled they are with thinking.Assessed by Likert Scale on multiple items (1 = Never True; 7 = always true)
Differential contribution of mindfulness for stress and mindfulness for pain courses on Acceptance and Commitment Therapy (ACT) process 1: Acceptance utilising The 7-item Acceptance and Action Questionnaire v.2
时间窗: baseline at recruitment; baseline, pre-intervention; during intervention (half-way); immediately after intervention; 3 months after the intervention
This will be utilised to measure and track the patient's change (if any) - at relevant time points in the study - in willingness to experience general unpleasant feelings and emotions that are not pain related (not to unfairly disadvantage the stress version of the course). Assessed by Likert scale on multiple itemts (1 = Never True ; 7 = Always true)
次要结局
- IMMPACT consistent, changes in Pain Interference (on functioning and aspects of quality of life) will be evaluated utilising the Brief Pain Inventory - Short Form (BPI)(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent, changes in Pain Intensity (How sore the participant is) will be evaluated utilising the Brief Pain Inventory - Short Form (BPI)(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent measurement of change in emotional functioning: depression screening utilizing the Beck Depression Inventory - Fast Screen (BDI-FS)(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent measurement of change in emotional functioning: catastrophizing, utilizing Pain Catastrophizing Scale (PCS)(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent measurement of change in participants' disposition via subjective impression of change on pain, interference from pain, resilience on a scale of -100% (worse) to + 100% better.(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent measurement of change in pain medication changes utilizing name and amount (mg/g) of pain / mood medication(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- IMMPACT consistent measurement of change in patient's ratings of global functioning(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
- Accident and Emergency (A&E) and primary care GP visits(baseline at recruitment; baseline, pre-intervention; during intervention (half-way, week 4 of 8); immediately after intervention; 3 months after the intervention)
研究者
Dr Alessio Agostinis
Consultant Clinical Psychologist
Government of Jersey