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Completed

NCT Number: NCT04331236

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

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.

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Key information

Conditions

Pediatric Chronic Pain

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

yoga

Other

Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.

Primary outcomes

  1. Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)

    Time frame: 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 outcomes

  1. Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference

    Time frame: 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.

  2. PROMIS Social Health - Peer Relationships

    Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention

    Quality of relationships with friends and other acquaintances.

  3. PROMIS Emotional Distress - Depressive Symptoms

    Time frame: 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).

  4. PROMIS Pediatric Global Health 7+2

    Time frame: 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.

  5. Pain Stages of Change Questionnaire - Child Proxy

    Time frame: 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

  6. Pain Catastrophizing Scale - Child Proxy

    Time frame: 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)

  7. Adult's Responses to Children's Symptoms - Child Proxy

    Time frame: 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)

  8. Visual Analog Pain Score

    Time frame: 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

  9. Pain Stages of Change Questionnaire - Parent Proxy

    Time frame: 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

  10. Pain Catastrophizing Scale - Parent Proxy

    Time frame: 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)

  11. Adult's Responses to Children's Symptoms - Parent Proxy

    Time frame: 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)

  12. Brief Symptoms Inventory - Parent Proxy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2024
First posted
Apr 2, 2020
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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