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

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status

Completed

Conditions

Pediatric Chronic Pain

Treatments

Behavioral: Cognitive Behavioral Therapy
Other: Yoga

Study type

Interventional

Funder types

Other

Identifiers

NCT04331236
18-015337

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

Patient and Caregiver Intervention
Experimental group
Description:
Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.
Treatment:
Other: Yoga
Behavioral: Cognitive Behavioral Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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