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

Pediatric Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04331236
• Other study ID #: 18-015337
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 25, 2024

Study information

• Verified date: October 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 25, 2024
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pediatric Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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