Internet-delivered ACT Treatment for Patients With Chronic Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Pain Interference Index (changes between assessments)
研究概览
简要总结
The overall aim of the present study is to evaluate an internet-delivered Acceptance and Commitment therapy treatment (iACT) for patients with chronic pain. More specifically, the study will evaluate if 1) iACT is effective in improving functioning and quality of life in comparison to a waitlist condition, 2) if iACT is cost-effective, 3) factors that influence treatment outcome (i.e. predictors, moderators or characteristics of treatment responders), 4) if psychological variables mediates the effects of treatment on outcome, and 5) if subgroups of patients varies in change processes (i.e. moderated mediation).
The main hypothesis is that iACT will improve functioning and quality of life.
详细描述
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced quality of life. Medical strategies are often ineffective or insufficient to alleviate symptoms and increase functioning. Instead, the empirical support for cognitive behavior therapy (CBT) is today well established, and such interventions are commonly seen as critically important for patients with chronic pain. However, modest effects sizes calls for further improvements. Recent developments within CBT, particularly Acceptance and Commitment Therapy (ACT), have suggested the utility of acceptance and mindfulness strategies to manage pain and distress. The body of evidence for ACT has grown rapidly during the past decade, and ACT is today listed by the American Psychological Association as a treatment for chronic pain, with strong empirical support.
Internet-delivered ACT
Despite the increased empirical support for ACT the availability is still very limited, and a large number of patients do not receive this treatment. In other domains, the accessibility of empirically supported treatments has increased during the past decade due to the development of methods to deliver the treatment via internet. For example, a large number of studies illustrate the utility of internet-delivered CBT for anxiety, insomnia and depression, with treatment effects similar to those obtained in studies with face-to-face treatment. Few studies have yet evaluated internet-delivered ACT (iACT) for chronic pain, but a recent pilot study from our group with participants suffering from fibromyalgia (n=41) illustrated very promising results that warrant further studies to evaluate the effects of this treatment.
Moderators and mediators of treatment outcome
If iACT shows to be effective, it is vital to identify for whom this treatment works. For example, it is possible that factors such as age, pain duration or depression may moderate the effects of treatment. Also, it is likely that some individuals who respond well to regular face-to-face treatment do not benefit from internet-delivered interventions. Furthermore, recent studies have shown that acceptance of pain and distress may be a more important mediator of change than e.g. pain intensity, catastrophizing or anxiety. However, no study has to our knowledge yet explored if subgroups of patients (e.g. men and women) improve via different change processes (i.e. moderated mediation). More information regarding moderators and mediators of change will make it possible to adjust and tailor interventions to meet specific individual needs, and thereby increase the effects of treatment.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a pain duration of ≥ 6 months;
- •are able to communicate in Swedish
- •have access to computer and internet in their home environment.
- •have access to a cell phone with the possibility of receiving text messages
- •no planned changes in medication use, or any other changes in interventions for their pain planned
排除标准
- •injury or illness that require immediate assessment or different treatment, or that is expected to progress significantly during the next 6 months
- •unstable medication (planned changes in medication during next 4 months)
- •previous ACT or CBT treatment during the past 3 months
- •severe psychiatric co-morbidity (e.g. high risk of suicide) as assessed by the psychologist in a semi-structured interview
研究组 & 干预措施
Treatment
Internet delivered Acceptance and Commitment therapy, supported by a psychologist/psychology student under supervision.
干预措施: Internet delivered Acceptance and Commitment therapy (Behavioral)
Waiting list control condition
Participants receive no treatment for ten weeks, i.e. waiting list condition. Following post-assessment, the control condition receive unguided iACT (i.e. the same content and structure as iACT but without systematic therapist communication).
干预措施: Waiting list control condition (Behavioral)
结局指标
主要结局
Pain Interference Index (changes between assessments)
时间窗: Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment
Self rated measure of daily functioning related to pain
次要结局
- The Valuing Questionnaire (changes)(Baseline, mid (4 weeks), post (10 weeks), follow ups three, six and twelve months post treatment)
- Psychological Inflexibility in Pain Scale (changes)(Baseline, 10 weekly ratings, post (10 weeks), follow ups three, six and twelve months post treatment)
- Patient Health Questionnaire 9 (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- European Quality of Life Five Dimensions Questionnaire (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- Pain Intensity (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- Insomnia Severity Index (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- Occupational status (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- Perceived Stress Scale - 4 items (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- General Anxiety Disorder - 7 item (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
- Medication use (changes)(Baseline, post (10 weeks), follow ups three, six and twelve months post treatment)
研究者
Rikard Wicksell
Director of Functional Area Medical Psychology, Karolinska Univ Hospital, assoc professor and head of research group Behavior Medcine, Karolinska Institutet
Karolinska Institutet
