Clinical trial NCT04331236: Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers
Official title: Yoga-Cognitive Behavioral Therapy (Y-CBT) Group Intervention for Adolescents With Chronic Pain and Their Caregivers: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Chronic Pain
Keywords: pediatric pain
cognitive behavioral therapy
yoga
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
timeFrame: Feasibility Questionnaires given after the 7-week intervention
Secondary outcomes:
measure: Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: PROMIS Social Health - Peer Relationships
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: PROMIS Emotional Distress - Depressive Symptoms
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: PROMIS Pediatric Global Health 7+2
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Pain Stages of Change Questionnaire - Child Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Pain Catastrophizing Scale - Child Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Adult's Responses to Children's Symptoms - Child Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Visual Analog Pain Score
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Pain Stages of Change Questionnaire - Parent Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Pain Catastrophizing Scale - Parent Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Adult's Responses to Children's Symptoms - Parent Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
measure: Brief Symptoms Inventory - Parent Proxy
timeFrame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
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.
citation: 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.
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.