Your session is about to expire
← Back to Search
Behavioral Intervention
Resilience Coaching for Adolescent Chronic Pain
N/A
Recruiting
Led By Sabrina Gmuca, MD MSCE
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 3 months post-randomization.
Awards & highlights
No Placebo-Only Group
Summary
This trial will research how resilience coaching could help teens with chronic pain. It'll compare those who receive resilience coaching to those who receive usual care. Results will show if it helps with functional disability, psychological distress, and pain intensity.
Who is the study for?
Adolescents aged 12-17 with chronic musculoskeletal pain, which includes bone, joint, muscle or related soft tissue pain lasting more than 3 months. They must have a caregiver to participate alongside them and both should primarily speak English. Those already receiving cognitive behavioral therapy or diagnosed with complex regional pain syndrome are excluded.
What is being tested?
The trial is testing the effectiveness of resilience coaching (PRISM) for teens with chronic musculoskeletal pain compared to usual care. It aims to see if PRISM can better improve how these adolescents cope with disability, psychological distress, and pain intensity.
What are the potential side effects?
Since this intervention involves coaching rather than medication, traditional side effects like those seen in drug trials may not apply. However, participants might experience emotional discomfort when discussing personal issues during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at 3 months post-randomization.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 3 months post-randomization.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional Disability
Secondary study objectives
Pain intensity
Psychological distress
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Resilience Coaching plus Usual CareExperimental Treatment1 Intervention
Promoting Resilience in Stress Management (PRISM) is a 1:1, remotely delivered, resilience coaching program for adolescents with chronic illness, consisting of skill-building sessions in stress management, goal setting, cognitive re-framing, and benefit-finding. Sessions are held every 1-2 weeks for a total of 4 required and one optional session and each session lasts about 30-45 minutes.
Group II: Usual CareActive Control1 Intervention
Usual care consists of an individualized treatment combining physical therapy, occupational therapy and psychological counseling. This is determined by the treating provider.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Promoting Resilience in Stress Management
2016
N/A
~110
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,778 Total Patients Enrolled
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,472,079 Total Patients Enrolled
Sabrina Gmuca, MD MSCEPrincipal InvestigatorChildren's Hospital of Philadelphia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My daily activities are affected by pain.I have been experiencing pain in my bones, joints, muscles, or related areas for 3 months or more.I experience pain only in my head or abdomen.I am currently undergoing cognitive behavioral therapy.I cannot give consent and do not have a legal guardian to do so for me.I have been diagnosed with complex regional pain syndrome.I am between 12 and 17 years old.I have been experiencing pain in my bones, joints, muscles, or related areas for 3 months or more.English is my primary language.I am between 12 and 17 years old.English is my primary language.I experience pain that affects my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Resilience Coaching plus Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.