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

NCT04331236 | Completed

• 1 other identifier: 18-015337
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Chronic Pain

Keywords

pediatric pain; cognitive behavioral therapy; yoga

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• PROMIS Social Health - Peer Relationships

  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

• 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 - Child Proxy

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

Study Arms (1)

Patient and Caregiver Intervention

EXPERIMENTAL

Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.

Behavioral: Cognitive Behavioral Therapy; Other: Yoga

Interventions

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.

Patient and Caregiver Intervention

Yoga OTHER

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

Patient and Caregiver Intervention

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 23428497 BACKGROUND

• 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.

  PMID: 24796681 BACKGROUND

• 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.

  PMID: 24804619 BACKGROUND

MeSH Terms

Interventions

Cognitive Behavioral Therapy; Yoga

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: November 1, 2019
• Primary Completion: June 15, 2020
• Study Completion: October 25, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

US (1)