ACTsmart - Feasibility of Smart Phone Delivered ACT Treatment for Adults With Longstanding Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Pain Interference Index (changes between assessments)
研究概览
简要总结
The aims are to test feasibility and preliminary effects of a smart phone delivered ACT treatment for adults with longstanding pain.
The hypotheses are that
- ACTsmart will be a feasible and accessable treatment delivery form
- ACTsmart will improve function and quality of life
详细描述
Chronic pain affects 12-30% of the population and often results in depression, disability, and reduced daily function and 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.
To make treatment more accessible and present in patients' daily life we will use a smart phone application to deliver treatment.
Recruitment Patients will be recruited through self referral. Information regarding the study will be provided through newspapers and social media, as well as in direct communication with pain clinics and primary care units, including instructions regarding e.g. eligibility and how to sign up. Once patients have been found eligible and expressed interest in study participation they will be assessed by a psychologist, and when needed by a pain physician, via semi-structured interviews to confirm eligibility and to ensure that the patient meet the study criteria. Informed consent is obtained from all participants prior to the assessment.
Statistical methods Evaluations of treatment effects are primarily based on intent-to-treat analyses. The statistical approach will primarily be based on linear multilevel modeling (LMM), which takes into account dependencies between repeated measures and differences between patients in pre-treatment status and treatment response (i.e. random effects modeling) and also provide means of handling missing data. More traditional methods, such as ANOVA and hierarchical regression, may also be utilized when appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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;
- •able to read and write in Swedish
- •have access to a smart phone with internet access
- •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)
- •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
结局指标
主要结局
Pain Interference Index (changes between assessments)
时间窗: Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment
Self rated measure of daily functioning related to pain
次要结局
- Psychological Inflexibility in Pain Scale (changes)(Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment)
- Medication use (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- European Quality of Life Five Dimensions Questionnaire (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- Generalized Anxiety Disorder - 7 (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- Valuing Questionnaire (changes)(Baseline, 8 weekly ratings, post (8 weeks), follow ups three, six and twelve months post treatment)
- Insomnia Severity Index (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- Occupational status (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- Patient Health Questionnaire 9 (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
- Pain intensity (changes)(Baseline, post (8 weeks), follow ups three, six and twelve months post treatment)
研究者
Rikard Wicksell
Associate professor
Karolinska Institutet
