GET Living: Graded Exposure Treatment for Children and Adolescents With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Decrease in Fear of Pain
研究概览
简要总结
The broad aim of the study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in children with chronic pain. Pain-related fear is an important psychological factor associated with poor outcomes in children suffering with chronic pain. To examine the efficacy of GET Living in addressing pain-related fears the investigators propose to use a sequential replicated randomized single-case experimental phase design with multiple measures. The specific aims are to 1) evaluate the effectiveness and acceptability of individually tailored GET Living for children with high pain-related fear and functional disability and 2) define anatomical and resting state connectivity patterns in the brains of children and adolescents with complex chronic pain prior to and after participation in GET Living.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain-related fear (score >40 on the Fear of Pain Questionnaire (FOPQ (Simons et al., 2011a))
- •Musculoskeletal, neuropathic limb or back pain, or headache
- •Functional limitations (score > 12 on the Functional Disability Inventory (FDI (Kashikar-Zuck et al., 2001; Walker and Greene, 1991)).
排除标准
- •Significant cognitive impairment (e.g., intellectual disability)
- •Serious psychopathology (e.g., active suicidality).
- •Acute trauma (e.g., spondylolithesis, disk herniation, fracture, acute tendonitis)
- •Systemic disease in active inflammatory state
- •Biomechanical deficit that would limit ability to engage in exposure activities (e.g. severe muscle atrophy)
- •Making gains in current physical therapy or have not had physical therapy, but it is clearly indicated
研究组 & 干预措施
GET Living Treatment
干预措施: GET Living (Behavioral)
结局指标
主要结局
Decrease in Fear of Pain
时间窗: Decrease in Fear of Pain from Baseline to end of treatment at 6-weeks, on average
次要结局
- Improvement in School Functioning(Improvement in School Functioning from baseline to end of treatment at 6-weeks, on average)
- Decrease in Pain Catastrophizing(Decrease in Pain Catastrophizing from baseline to end of treatment at 6-weeks, on average)
- Decrease in Pain Intensity(Decrease in Pain Intensity from baseline to end of treatment at 6-weeks, on average)
- Decrease in Functional Disability(Decrease in Functional Disability from Baseline to end of treatment at 6-weeks, on average)
- Increase in Physical Activity(Increase in Physical Activity from baseline to end of treatment at 6-weeks, on average)
研究者
Laura Simons(Giardi)
Staff Psychologist
Boston Children's Hospital