NCT04331236已完成不适用
Yoga-Cognitive Behavioral Therapy (Y-CBT) Group Intervention for Adolescents With Chronic Pain and Their Caregivers: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
研究概览
简要总结
Clinical symptoms that are often found to be comorbid with pediatric chronic pain include anxiety, depression as well as increased stress, obesity, and decreased physical conditioning. Integrative therapies have been increasingly offered at children's hospitals as part of an integrated approach to treatment. Limited research exits on the efficacy of mind-body practices (e.g., yoga) utilized in conjunction with evidenced-based non-pharmacological treatments like cognitive behavioral therapy (CBT) to treat pediatric pain. Hence, this 7-week interventional pilot study was conducted to evaluate the impact of combining yoga and CBT for both pediatric patients with chronic pain and their 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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established Children's Hospital of Philadelphia (CHOP) patients 14-18 years old, of any gender, race, or ethnicity
- •English speaking
- •Has received a diagnosis related to the primary symptom of chronic pain
- •For adolescents who are less than 18 y/o, parental or guardian permission (informed consent) and adolescent assent (patient)
- •Parents or legal guardians of adolescents enrolled, who speak English
- •Parents or legal guardians' permission (informed consent) of their own participation
排除标准
- •Current medical status or cognitive functioning precludes completing assessment instruments (e.g., cognitive or intellectual disability such as diagnosis of autism spectrum disorder)
- •Physical limitation, handicap, or injury that would prevent participation or risk further injury or harm (e.g. physical assistance required from a device)
- •Non-English speaking
- •For adolescents who are less than 18 years of age, parental or guardian permission (informed consent) and/or adolescent (patient) assent declined
- •Patient, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures
- •Parents or legal guardians of adolescents enrolled, who do not speak English
- •Parents or legal guardians' permission (informed consent) for their own participation or if the adolescent is less than 18 years of age and assent has been declined
- •Parents or legal guardians, who in the opinion of the investigator, may be non-compliant or unable to complete the study procedures (If the dyad or triad includes a primary caregiver who has a developmental delay, intellectual disability, or communication challenge that prohibits completion of questionnaires or participation in study sessions)
结局指标
主要结局
Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
时间窗: Feasibility Questionnaires given after the 7-week intervention
Likert-scale used to quantify satisfaction with the intervention; content clarity; concept-applicability to current life; impression of program design; scheduling considerations and other open-ended questions about their study preferences
次要结局
- PROMIS Social Health - Peer Relationships(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- PROMIS Pediatric Global Health 7+2(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Pain Stages of Change Questionnaire - Parent Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Pain Catastrophizing Scale - Parent Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Pain Catastrophizing Scale - Child Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Pain Stages of Change Questionnaire - Child Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Brief Symptoms Inventory - Parent Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- PROMIS Emotional Distress - Depressive Symptoms(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Visual Analog Pain Score(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Adult's Responses to Children's Symptoms - Parent Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
- Adult's Responses to Children's Symptoms - Child Proxy(Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
MBCT and CBT for Chronic Pain in Multiple SclerosisMultiple SclerosisNCT03782246University of Washington273
已完成
不适用
A Trial of Yoga in Pediatric Inflammatory Bowel DiseaseUlcerative ColitisCrohn's DiseaseInflammatory Bowel DiseaseNCT03338894Atlantic Health System78
Unknown
不适用
Transdiagnostic Group Cognitive Behavioral Therapy (PsicAP-A) for Adolescents With Emotional DisordersEmotional DisorderNCT04289740Instituto de Investigación Marqués de Valdecilla160
已完成
不适用
Facing Fears by Focussing on Behaviour, Body, or Mind?Social AnxietyNCT03711513University of Groningen65
招募中
3 期
Cognitive behavioral therapy for chronic pain in Japan: a randomized controlled trialChronic PainJPRN-UMIN000042798Kansai University60