Smartphone Delivered Acceptance and Commitment Therapy for Adolescents With Longstanding Pain - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pain Interference Index (PII)
研究概览
简要总结
Intervention study with uncontrolled design investigating the effects of smartphone delivered Acceptance and Commitment Therapy for longstanding pain in adolescents. Primary outcome is pain interference. Internet-based parental support will be offered to the adolescents' caregivers.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pain duration of ≥ 3 months;
- •the pain condition has been examined by a medical doctor
- •able to communicate in Swedish
- •access to a smartphone and internet connection on a daily basis
- •stable medication use since 2 months time, with no planned changes
排除标准
- •previous ACT or CBT treatment during the past 6 months
- •severe psychiatric co-morbidity (e.g. psychosis or 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 (PII)
时间窗: Pre-treatment, weekly for eight weeks (during treatment), after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up)
Change in pain interference on the adolescent daily activities. Items are rated on a 7-point Likert scale, and the total score is the mean of the completed items. Higher scores indicate more interference.
次要结局
- Pediatric Quality of Life Inventory (PedsQL)(Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up))
- Center for Epidemiological Studies Depression Scale for Children (CES-DC)(Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up))
- Psychological Inflexibility in Pain Scale (PIPS)(Pre-treatment, weekly for eight weeks (during treatment), after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up))
- Insomnia Severity Index (ISI)(Pre-treatment, after 8 weeks (i.e. post-treatment), 8 weeks and 4 months after treatment is completed (i.e. 4 months follow-up), 8 weeks and 1 year after treatment (i.e. 1 year follow-up).)
研究者
Rikard Wicksell
Associate Professor
Karolinska Institutet