Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to learn about resilience coaching in adolescents with chronic musculoskeletal pain. The main questions it aims to answer are to 1) determine how helpful resilience coaching is for teens with chronic musculoskeletal pain, 2) which participants are best suited for resilience coaching, and 3) barriers and facilitators to implementing resilience coaching as part of routine clinical care. Participants will complete survey measures and participate in the resilience coaching intervention called Promoting Resilience in Stress Management (PRISM). Researchers will compare youth in PRISM to those receiving usual care to determine whether PRISM leads to greater improvements in functional disability, psychological distress, and pain intensity than usual care alone.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The purpose of this study is to find out if a resilience coaching program called Promoting Resilience in Stress Management (PRISM) can help youth with chronic musculoskeletal pain better cope with their chronic illness.Researchers will recruit a total of 120 youth with chronic musculoskeletal pain and one of their caregivers (total number of participants = 240). Teens will be randomly assigned to either a control group (usual care) or a treatment group (PRISM + usual care). PRISM consists of 4 study visits with a resilience coach, and one optional coming together session where you parents are invited to join. This will occur over approximately 12 weeks. All participants will complete survey measures at baseline, 3-months and 9 months. Selected participants in PRISM will be invited to participate in interviews to provide feedback on the intervention. At the end of the study, researchers will assess whether participants in PRISM had improved functional disability, psychological distress and pain intensity as compared to the usual care arm.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Resilience Coaching plus Usual Care 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. |
Behavioral: Promoting Resilience in Stress Management
Resilience coaching program.
|
| Active Comparator: Usual Care Usual care consists of an individualized treatment combining physical therapy, occupational therapy and psychological counseling. This is determined by the treating provider. |
Other: Usual Care
Combination of physical therapy, occupational therapy, and psychological counseling as recommended by the treating provider.
|
Outcome Measures
Primary Outcome Measures
- Functional Disability [Measured at 3 months post-randomization.]
Functional disability at 3 months will be measured via the Functional Disability Inventory (FDI) score (ranging from 0-60 with higher scores indicating greater self-perceived functional disability).
Secondary Outcome Measures
- Psychological distress [Measured at 3 months post-randomization.]
Psychological distress at 3 months will be measured via the Kessler Psychological Distress Scale (K6) score. Responses are scored on 5-point Likert scale (total score ranging from 0-24). Previous studies have shown that scores ≥ 7 are consistent with "high" distress and those ≥ 13 meet criteria for serious, or debilitating psychological distress.
- Pain intensity [Measured at 3 months post-randomization.]
Pain intensity at 3 months will be measured via the PROMIS (Patient Reported Outcome Measure Information System) Pediatric Numeric Rating Scale v1.0- Pain Intensity score (ranging from 0-10 with higher scores indicating greater pain intensity).
Eligibility Criteria
Criteria
Inclusion Criteria:
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ages 12-17 years,
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newly diagnosed with chronic musculoskeletal pain, defined as bone, joint, muscle, or related soft tissue pain lasting ≥ 3 months
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willing to provide informed consent/assent
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one caregiver willing to consent and participate in dyad
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dyad identifies English as primary language
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mild or greater impairment due to pain (defined as Patient Reported Outcomes Measurement Information System Pain Interference T-score ≥ 60 at time of last clinic visit and/or self- or parent- reported impairment of activities of daily living due to pain at time of screening)
Exclusion Criteria:
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unable to provide assent and/or without a legal guardian able to provide consent for the study subject or themselves
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isolated/localized head pain or abdominal pain
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complex regional pain syndrome (CRPS)
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Receiving cognitive behavioral therapy at time of enrollment
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's Hospital of Philadelphia
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Sabrina Gmuca, MD MSCE, Children's Hospital of Philadelphia
Study Documents (Full-Text)
None provided.More Information
Publications
- 22-020664
- K23AR081409