Back to resultsYoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers
Primary Purpose
Pediatric Chronic Pain
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Chronic Pain focused on measuring pediatric pain, cognitive behavioral therapy, yoga
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)
Sites / Locations
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient and Caregiver Intervention
Arm Description
Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
PROMIS Social Health - Peer Relationships
Quality of relationships with friends and other acquaintances.
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).
PROMIS Pediatric Global Health 7+2
Overall evaluation of one's physical and mental health.
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
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)
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)
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
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
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)
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)
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
Full Information
NCT ID
NCT04331236
First Posted
March 31, 2020
Last Updated
May 10, 2023
Sponsor
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT04331236
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Chronic Pain
Keywords
pediatric pain, cognitive behavioral therapy, yoga
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient and Caregiver Intervention
Arm Type
Experimental
Arm Description
Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.
Primary Outcome Measure Information:
Title
Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
Description
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
Time Frame
Feasibility Questionnaires given after the 7-week intervention
Secondary Outcome Measure Information:
Title
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference
Description
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.
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
PROMIS Social Health - Peer Relationships
Description
Quality of relationships with friends and other acquaintances.
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
PROMIS Emotional Distress - Depressive Symptoms
Description
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).
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
PROMIS Pediatric Global Health 7+2
Description
Overall evaluation of one's physical and mental health.
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Pain Stages of Change Questionnaire - Child Proxy
Description
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
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Pain Catastrophizing Scale - Child Proxy
Description
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)
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Adult's Responses to Children's Symptoms - Child Proxy
Description
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)
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Visual Analog Pain Score
Description
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
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Pain Stages of Change Questionnaire - Parent Proxy
Description
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
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Pain Catastrophizing Scale - Parent Proxy
Description
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)
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Adult's Responses to Children's Symptoms - Parent Proxy
Description
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)
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Title
Brief Symptoms Inventory - Parent Proxy
Description
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
Time Frame
Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23428497
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.
Results Reference
background
PubMed Identifier
24796681
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.
Results Reference
background
PubMed Identifier
24804619
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.
Results Reference
background
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Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers
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