"Pilot Study to Compare the Effectiveness of a Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioural Intervention to Improve Self-care and Quality of Life in a Chronic Pain Sample"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Self-Compassion
研究概览
简要总结
Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.
Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.
The investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.
Moreover, investigators also hypothesize that MSC program will be, at least, as effective as CBT program in order to maintain the achieved benefits in a 6 months follow-up.
Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic pain sample of patients of Hospital Universitario La Paz, Madrid.
After all recollection of data is done, investigators will conduct statistic analysis in order to accept or refuse our hypothesis.
详细描述
Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.
Recent studies have elucidated that some conditions are clearly correlated with chronic pain, and could explain emotional distress and impairment in these patients. Such conditions are: attention bias to pain, cognitive inflexibility, fear avoidance, catastrophizing, passive coping with pain and no acceptance.
Recent meta-analysis suggest that Mindfulness-based interventions reduce anxiety and pain interference in daily life in patients with chronic pain. They do so through mechanisms that improve capacity of acceptance (whatever the experience is) and reduce catastrophizing. Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.
Neff and Germer have developed a specific program to enhance self-compassion named Mindful Self-Compassion (MSC) that could be helpful to people with clinical problems. In spite of promising results of this interventions based on acceptation and self-compassion, its effectiveness on chronic pain conditions remains still unclear.
Investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Older than 18 years old.
- •Being in treatment in the Chronic Pain Unit at Hospital Universitario La Paz because of having a chronic pain of more than 3 months of duration, no matter the aetiology.
- •Capable of understanding and giving his or her written informed consent.
- •Significant levels of distress related to the pain at the beginning of treatment, assessed by clinical interview and HADS (HADS-A or HADS-D > or = 8).
- •Patients that meet criteria for Mixed Adaptive Disorder, mild to moderate Depressive Disorder or Dysthymia, assessed by clinical interview conducted by a psychiatry of the Chronic Pain Unit or Mental Health Center.
排除标准
- •Intelectual disability or cognitive impairment or dementia.
- •Insufficient knowledge of the language to understand and participate on the intervention program.
- •Serious mental illness in acute state at the moment of the beginning of the intervention.
- •Substance abuse in the last 6 months.
- •Autolytic ideas at the moment of the assessment.
- •Previous training in mindfulness or CBT techniques.
结局指标
主要结局
Self-Compassion
时间窗: Up to 8 weeks
Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.
次要结局
- Quality of life(Day 1 of the intervention)
- Acceptance(Day 1 of the intervention)
- Catastrophising(Day 1 of the intervention)
- Adherence to the treatment(Up to 8 weeks.)
- Self-Compassion(Day 1 of the intervention)
- Pain Interference(Day 1 of the intervention)
- Pain Intensity(Day 1 of the intervention)
- Anxiety and Depression(Day 1 of the intervention)
- Satisfaction with the treatment(Up to 8 weeks.)
研究者
Angela Palao
Psychiatry. PhD.
Instituto de Investigación Hospital Universitario La Paz