Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Yoga-Cognitive Behavioral Therapy (Y-CBT) Group Intervention for Adolescents With Chronic Pain and Their Caregivers: A Feasibility Study

Conditions
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Pediatric Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Other: Yoga


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient and Caregiver Intervention<br>Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks. | Behavioral: Cognitive Behavioral Therapy<br>* CBT trains individuals to identify and reframe dysfunctional thoughts to help improve mood and behavior. CBT intervention also includes teaching relaxation and mindfulness strategies, as well as ways to help improve functioning through the use of behavioral goal setting.<br>Other: Yoga<br>* Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT) | 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 | Feasibility Questionnaires given after the 7-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference | 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. | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| PROMIS Social Health - Peer Relationships | Quality of relationships with friends and other acquaintances. | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| PROMIS Emotional Distress - Depressive Symptoms | 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). | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| PROMIS Pediatric Global Health 7+2 | Overall evaluation of one's physical and mental health. | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Pain Stages of Change Questionnaire - Child Proxy | 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 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Pain Catastrophizing Scale - Child Proxy | 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) | 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 | 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) | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Visual Analog Pain Score | 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 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Pain Stages of Change Questionnaire - Parent Proxy | 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 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Pain Catastrophizing Scale - Parent Proxy | 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) | 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 | 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) | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 
| Brief Symptoms Inventory - Parent Proxy | 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 | Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric pain, cognitive behavioral therapy, yoga