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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2024-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatments for Improving Mood in Depressed Teens-3

NCT03831360

Depression

COMPLETED NA

Web-based CBT for Children With Chronic Pain

NCT00853138

Chronic Pain Headache Abdominal Pain

COMPLETED PHASE2

Treatments for Improving Mood in Depressed Teens-2

NCT03831347

Depression

COMPLETED NA

Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care

NCT01147614

Anxiety Depression

COMPLETED NA

Family and Peer Involvement in the Treatment of Anxiety Disorders in Children

NCT00073645

Anxiety Disorders

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient and Caregiver Intervention

Patient and Caregivers receive both cognitive behavioral intervention and yoga interventions each week, for 7 weeks.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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.

Yoga

Intervention Type OTHER

Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Yoga

Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No