Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers
- Conditions
- Pediatric Chronic Pain
- Interventions
- Behavioral: Cognitive Behavioral TherapyOther: Yoga
- Registration Number
- NCT04331236
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient and Caregiver Intervention Cognitive Behavioral Therapy Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks. Patient and Caregiver Intervention Yoga Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.
- Primary Outcome Measures
Name Time Method Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT) 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
- Secondary Outcome Measures
Name Time Method PROMIS Social Health - Peer Relationships Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention Quality of relationships with friends and other acquaintances.
PROMIS Pediatric Global Health 7+2 Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention Overall evaluation of one's physical and mental health.
Pain Stages of Change Questionnaire - Parent Proxy Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention A validated 30-item self-report measure (ages 12-18) that will assess the readiness or receptiveness of adolescents and their parents to adopt a self-management approach to pain
Pain Catastrophizing Scale - Parent Proxy Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention A 13-item self-report scale (ages 8-17) with versions that will evaluate catastrophizing thinking in the adolescent subjects as well as parents (in relation to their child's pain)
Pain Catastrophizing Scale - Child Proxy Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention A 13-item self-report scale (ages 8-17) with versions that will evaluate catastrophizing thinking in the adolescent subjects as well as parents (in relation to their child's pain)
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 Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Pain Stages of Change Questionnaire - Child Proxy Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention Validated 30-item self-report measure (ages 12-18) that will assess the readiness or receptiveness of adolescents and their parents to adopt a self-management approach to pain
Brief Symptoms Inventory - Parent Proxy Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention A 53-item self-report measure that will assesses psychological functioning in adults. The instrument has three global indices as well as nine symptom dimensions: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism
PROMIS Emotional Distress - Depressive Symptoms Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention Negative mood (sadness, guilt), views of self (self- criticism,worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).
Visual Analog Pain Score Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention An established patient-reported measure that will quantify each adolescent subject's pain severity. With anchors at 0 (No pain) and 100 (Worst pain possible), these subjects will indicate the level of pain intensity on a 100 mm line
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 A 29-item validated measure (ages 8-18) that will assess the behavior of parents (caregivers) in response to their child's pain, as self-reported by the parent (or reported by the child)
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 A 29-item validated measure (ages 8-18) that will assess the behavior of parents (caregivers) in response to their child's pain, as self-reported by the parent (or reported by the child)
Trial Locations
- Locations (1)
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States