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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Chronic Pain
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Other: Yoga

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient and Caregiver Intervention; Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.

Behavioral: Cognitive Behavioral Therapy; 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.; Other: Yoga; Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Khalsa MK, Greiner-Ferris JM, Hofmann SG, Khalsa SB. Yoga-enhanced cognitive behavioural therapy (Y-CBT) for anxiety management: a pilot study. Clin Psychol Psychother. 2015 Jul-Aug;22(4):364-71. doi: 10.1002/cpp.1902. Epub 2014 May 7.
• Hainsworth KR, Salamon KS, Khan KA, Mascarenhas B, Davies WH, Weisman SJ. A pilot study of yoga for chronic headaches in youth: promise amidst challenges. Pain Manag Nurs. 2014 Jun;15(2):490-8. doi: 10.1016/j.pmn.2012.12.002. Epub 2013 Feb 19.
• Eccleston C, Palermo TM, Williams AC, Lewandowski Holley A, Morley S, Fisher E, Law E. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. 2014 May 5;2014(5):CD003968. doi: 10.1002/14651858.CD003968.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 15, 2020
• Study Completion (Estimated): October 25, 2024

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; yoga; pediatric pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 18-015337

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No