Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score
研究概览
简要总结
The purpose of this study is to find out how teenagers with chronic pain and sickle cell disease respond to a new training program called Back2Life and get their feedback about how to modify the program to best fit their needs. The Back2Life training program focuses on teaching pain coping skills (also known as cognitive-behavioral therapy). The program teaches skills and strategies that may help teens improve chronic pain management and get back into their everyday activities.
详细描述
Sickle cell disease (SCD) is a genetic disorder of the hemoglobin in which the course of acute pain from vaso-occlusion and its sequelae vary widely across genotypes and individual patients. SCD pain often begins during childhood and can progress to chronic pain for approximately 23% of children and adolescents. Youth with chronic SCD pain, that is pain that is present on most days per month and persists for at least 6 months, report high levels of functional disability, elevated depressive and anxiety symptoms, and reduced quality of life relative to youth with SCD without chronic pain. The complex, multifactorial nature of chronic SCD pain can also contribute to increased healthcare utilization for pain. The most effective management and treatment of chronic SCD pain likely requires individualized, multimodal, multidisciplinary treatments that go beyond pharmacological management alone. A range of evidence-based non-pharmacological treatments, such as behavioral health, complementary, and integrative health approaches, are recommended for chronic pain management and are gaining greater awareness and integration into comprehensive chronic pain care.
Behavioral health treatment, such as cognitive-behavioral therapy (CBT) for pain, focuses on improved daily functioning and coping through several core treatment components such as psychoeducation about how the body processes pain, relaxation skills training, and cognitive strategies. Youth with chronic SCD pain need an evidence-based, culturally informed, adaptive treatment. Behavioral treatments that are tailored to patient and family needs are beneficial when patients may require different levels of care. Adaptive designs are more effective in improving health outcomes, satisfaction with treatment, and reducing healthcare use than standard protocols where patients receive a fixed "one size fits all" treatment that is not personalized to their needs; adaptive designs are also recommended for tailoring evidence-based interventions with culturally diverse populations. Adaptive treatments can integrate evidence-based strategies to address common co-morbid problems associated with chronic pain, such as elevated anxiety or depressive symptoms or sleep disturbance. Teaching parents problem-solving skills can reduce caregiver stress among families managing chronic pain and illness.
This study utilizes an adaptive behavioral treatment to target psychosocial risk factors for youth with chronic SCD pain as a first step towards developing a stepped care model for SCD pain. The proposed treatment, called Back2Life, is innovative because it is culturally informed by families' and patients' feedback regarding their treatment preferences and targets psychological co-morbidities that are often excluded in clinical trials. The overarching hypothesis driving the proposed intervention is that disrupting the complex interacting psychosocial factors that can exacerbate chronic SCD pain will prevent and/or reduce poor health outcomes in children and adolescents with SCD. Reductions in inflammatory biomarkers are examined as an exploratory hypothesis and participants can consent to an optional blood draw for this portion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score
时间窗: Baseline, Immediately Post-Treatment, Month 3, Month 6
The PROMIS Pediatric Short Form for Pain Interference, Self- and Parent-Proxy Report, is an 8-item self-report measure assessing functional interference due to pain in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased hindrance of life activities due to pain.
Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score
时间窗: Baseline, Immediately Post-Treatment, Month 3, Month 6
The Sickle Cell Pain Burden Interview for Youth, Self-Report is a 7-item, validated measure of pain burden in 7-21 year olds. Responses are given on a 5-point Likert scale where 0 = none and 4 = every. The patient self-reports the amount of days in the past month where pain occurred or pain impacted daily life. Total scores range from 0 to 28 and higher scores indicate a greater pain burden.
Child Self-Efficacy Scale Score
时间窗: Baseline, Immediately Post-Treatment, Month 3, Month 6
Child Self-Efficacy Scale, Self- and Parent-Proxy Report is a well-established, 7-item measure of self-efficacy for functioning despite pain for 8-19 year olds. Respondents report how sure about their (or their child's) ability to perform certain daily tasks when they have pain, on a scale from 1 to 5 where 1 = very sure and 5 = very unsure. Total scores range from 7 to 35 and lower scores indicate greater self-efficacy.
PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report Score
时间窗: Baseline, Immediately Post-Treatment, Month 3, Month 6
The PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report is an 8-item measure completed by parents that assesses pain behaviors displayed by their child in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased behaviors due to pain.
Number of Dyads Completing the Study
时间窗: Month 6
Treatment feasibility was assessed by the number of participant dyads who complete the study.
Number of Dyads Completing Study Assignments Within Six Months
时间窗: Month 6
Treatment feasibility was assessed by the number of dyads completing the 6-Month study assignment.
Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview
时间窗: Immediately Post-Treatment
Treatment feasibility was assessed via a qualitative interview where participants were asked open ended questions. Participants were asked if they thought the Back2Life program helpful, if delivering the program through telemedicine was reasonable, and if the program was a reasonable approach for chronic pain management of sickle cell disease.
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
时间窗: Immediately Post-Treatment
The Treatment Evaluation Inventory-Short Form was completed at the end of treatment. It includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.
次要结局
- Emergency Department Visits Per Participant(12 months prior to Baseline, 12 months post-treatment)
- Hospital Admissions Per Participant(12 months prior to Baseline, 12 months post-treatment)
- Days Per Week of Opioid Use(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- Pediatric Inventory for Parents (PIP) Score(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- Adolescent Sleep Wake Scale (ASWS) Score(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- PROMIS Pediatric Short Form Depressive Symptoms Score(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- Pain Catastrophizing Scale Score(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- Pain Stages of Change Questionnaire (PSOCQ) Action Scale Score(Baseline, Immediately Post-Treatment, Month 3, Month 6)
- Interleukin -1β (IL-1β) Concentration(Baseline, Month 3, Month 6)
- IInterleukin 6 (IL-6) Concentration(Baseline, Month 3, Month 6)
- Interleukin 8 (IL-8) Concentration(Baseline, Month 3, Month 6)
- Tumor Necrosis Factor - Alpha (TNF-α) Concentration(Baseline, Month 3, Month 6)
- C-Reactive Protein (CRP) Concentration(Baseline, Month 3, Month 6)
- Brain-Derived Neurotrophic Factor (BDNF) Concentration(Baseline, Month 3, Month 6)
- Interferon Gamma (IFN-y) Concentration(Baseline, Month 3, Month 6)
研究者
Soumitri Sil
Associate Professor
Emory University