Psychological Treatment Targeting Acceptance and Compassion in Chronic Pain Patients: a Randomized Controlled, Internet Delivered, Treatment Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Pain Disability index (PDI)
研究概览
简要总结
This trial is a randomized controlled study aiming to investigate the effect of an 8-week internet-based intervention focused on acceptance and compassion or a wait-list control group. Primary treatments outcomes are Chronic Pain Acceptance Questionnaire (CPAQ), Self-Compassion Scale (SCS) and Pain Disability index (PDI). Secondary outcomes were Montgomery Åsberg Depression Rating Scale (MADRS-S), Anxiety sensitivity index (ASI), Quality of Life Inventory (QOLI), Multidimensional Pain Inventory (MPI) and Perseverative Thinking Questionnaire (PTQ). A six month follow-up was conducted. Findings showed significantly greater levels of acceptance (CPAQ), self-compassion (SCS) and reduction in activity limitation (PDI) measured with the primary outcomes for the treatment group after the intervention with effect sizes raging from small to moderate and these results were maintained at six-month follow-up.
详细描述
The purpose of this study was to explore if a psychological treatment fusing ACT and CFT principles and therapeutic techniques could improve outcome in chronic pain patients with high levels of self-criticism in comparison to a wait-list control group. The treatment was delivered via the internet, guided by trained professional. Internet delivered cognitive behavior therapy (CBT) and ACT treatments have shown similar efficacy as compared to face-to-face treatments in a variety of problem areas and across a large range of outcomes. Participants were recruited from a clinical setting. The treatment program consisted of eight sections and was based on a manual based on ACT developed for chronic pain (Buhrman et al., 2013) and a CFT-manual for chronic pain.
Following a screening interview participants deemed eligible were asked to complete an assessment battery online. All correspondence concerning treatment was held through a web portal including the online questionnaires and a secure e-mail service. The system handled security issues with two factor authentication. The participants logged in with electronic identification which is a secure service used by banks and in clinical settings.
Measures were obtained pre- and post- intervention and administered via the internet. A sixth month follow-up of the treatment group was administered. Mediation measures were also obtained.
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
- •have experienced pain for more than three months,
- •have been medically investigated (within the past year)
- •be at least 18 years of age
- •have regular access to a computer and the internet
- •reported self-criticism measured with the Self-Compassion Scale.
排除标准
- •planned surgery
- •ongoing medical investigation that could impede participation in the study,
- •suffering from acute physical or psychological conditions,
- •very severe symptoms of depression (i.e., defined as a score of >2 on item 9 on MADRS-S and information from telephone screening)
- •ongoing psychological treatment,
- •not being fluent with the Swedish language since all the material would be in Swedish.
研究组 & 干预措施
Internet-delivered ACT and CFT
8 week, guided internet- delivered acceptance and commitment therapy (ACT) and compassion focused therapy (CFT)
干预措施: Internet-Delivered ACT and CFT (Behavioral)
Wait list control group
Wait list control group, received treatment at later point.
结局指标
主要结局
Pain Disability index (PDI)
时间窗: At 8 weeks (post-treatment) and 6 months follow-up
Change from baseline in disability. It measures the degree to which pain. Every item score can range from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference interferes with functioning across a range of activities.
Chronic Pain Acceptance Questionnaire (CPAQ)
时间窗: At 3, 8 weeks (post-treatment) and 6 months follow-up
Chronic pain acceptance questionnaire (CPAQ) measures acceptance. The measure consists of two scales; willingness and activity engagement. Items are rated on a scale from 0 (never true) to 6 (always true).Higher scores denote greater activity engagement and pain willingness.The total score is also reported
Self-Compassion Scale (SCS)
时间窗: At 3, 8 weeks (post-treatment) and 6 months follow-up
Change from baseline in compassion. The items in Self-Compassion Scale (SCS) are rated on a likert scale from 1(almost never) to 5 (almost always). The scale is divided into six subscales: self-kindness (higher values are considered better), self-judgement (lower values are considered better), common humanity (higher values are considered better), isolation(lower values are considered better), mindfulness (highervalues are considered better) and over-identified (lower values are considered better).Higher scores in the total scale indicate higher levels of compassion. l scale.Results can be presented for the different subclass or a total score. To compute a total self-compassion score, you reverse the negative scales items (self-judgment, isolation, and over-identification ) before computing the grand mean. Subscale scores are computed by calculating the mean of subscale item responses. Higher scores indicate higher levels of self-compassion. A total score can also be reported.
次要结局
- Quality of Life Inventory (QOLI)(At 8 weeks (post-treatment) and 6 months follow-up)
- Multidimensional Pain Inventory (MPI)(At 8 weeks (post-treatment) and 6 months follow-up)
- Montgomery Åsberg Depression Rating Scale (MADRS-S)(At 8 weeks (post-treatment) and 6 months follow-up)
- Anxiety sensitivity index (ASI)(At 8 weeks (post-treatment) and 6 months follow-up)
- Perseverative Thinking Questionnaire (PTQ)(At 3, 8 weeks (post-treatment) and 6 months follow-up)