Pediatric Chronic PainNCT04331236
Yoga-CBT Group Intervention for Adolescents With Chronic Pain and Their Caregivers
A study testing Cognitive Behavioral Therapy and Yoga in people with Pediatric Chronic Pain, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Pediatric Chronic Pain
- What is being tested?
- Cognitive Behavioral Therapy and Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Yoga-Cognitive Behavioral Therapy (Y-CBT) Group Intervention for Adolescents With Chronic Pain and Their Caregivers: A Feasibility Study
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
- Being tested
- Cognitive Behavioral Therapy, Yoga
- Keywords
- pediatric pain, cognitive behavioral therapy, yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
YogaOther
Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.
| Study group | Role | What they receive |
|---|---|---|
| Patient and Caregiver Intervention | Experimental | Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks. Receives: Behavioral: Cognitive Behavioral Therapy; Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Feasibility Questionnaires given after the 7-week intervention
Secondary outcomes (12)
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.
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Social Health - Peer Relationships
Quality of relationships with friends and other acquaintances.
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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).
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Pediatric Global Health 7+2
Overall evaluation of one's physical and mental health.
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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)
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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)
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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)
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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)
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
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
Measured: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Nov 2019
- Primary completion15 Jun 2020
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pediatric Chronic PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331236
- Sponsor's protocol ID
- 18-015337
- Status last verified
- Nov 2024
- First submitted
- 31 Mar 2020
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23428497Eccleston 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.
PubMed 24796681Khalsa 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.
PubMed 24804619
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga-Cognitive Behavioral Therapy (Y-CBT) Group Intervention for Adolescents With Chronic Pain and Their Caregivers: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04331236
- Acronym / sponsor ID
- 18-015337
- Conditions
- Pediatric Chronic Pain
- Keywords
- pediatric pain, cognitive behavioral therapy, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient and Caregiver Intervention | Experimental | Behavioral: Cognitive Behavioral Therapy, Other: YogaPatient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCBT 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. | Behavioural | Patient and Caregiver Intervention |
| YogaYoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions. | Other | Patient and Caregiver Intervention |
Primary outcome
Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT)
Time frame: Feasibility Questionnaires given after the 7-week intervention
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
12 secondary outcomes
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Pain Interference
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Social Health - Peer Relationships
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Emotional Distress - Depressive Symptoms
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
PROMIS Pediatric Global Health 7+2
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Stages of Change Questionnaire - Child Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Catastrophizing Scale - Child Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Adult's Responses to Children's Symptoms - Child Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Visual Analog Pain Score
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Stages of Change Questionnaire - Parent Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Pain Catastrophizing Scale - Parent Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Adult's Responses to Children's Symptoms - Parent Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Brief Symptoms Inventory - Parent Proxy
Time frame: Given before the intervention (Week 1), after the intervention (Week 7) and 3 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 23428497Hainsworth 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.
- Background: PubMed 24796681Eccleston 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.
- Background: PubMed 24804619Khalsa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Yoga in people with Pediatric Chronic Pain, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the feasibility of conducting a 7-week group intervention combining yoga and cognitive behavioral therapy (CBT) (time frame: Feasibility Questionnaires given after the 7-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331236, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.