Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

Pain, Chronic Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834725
• Other study ID #: 22-020664
• Secondary ID: K23AR081409
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: Mackenzie McGill, MD, MSCE
• Phone: 267-426-8726
• Email: mcgillm1[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• ages 12-17 years,
• newly diagnosed with chronic musculoskeletal pain, defined as bone, joint, muscle, or related soft tissue pain lasting = 3 months
• willing to provide informed consent/assent
• one caregiver willing to consent and participate in dyad
• dyad identifies English as primary language
• 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:

• unable to provide assent and/or without a legal guardian able to provide consent for the study subject or themselves
• isolated/localized head pain or abdominal pain
• complex regional pain syndrome (CRPS)
• Receiving cognitive behavioral therapy at time of screening

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain
• Pain Syndrome
• Pain, Chronic
• Psychological

Intervention

Behavioral:
• Promoting Resilience in Stress Management
Resilience coaching program.

Other:
• Usual Care
Combination of physical therapy, occupational therapy, and psychological counseling as recommended by the treating provider.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gmuca S, Weiss PF, McGill M, Xiao R, Ward M, Nelson M, Sherry DD, Cronholm PF, Gerber JS, Palermo TM, Young JF, Rosenberg AR. The Feasibility and Acceptability of Resilience Coaching for Adolescent Chronic Musculoskeletal Pain: A Single-Arm Pilot Trial. Children (Basel). 2022 Sep 21;9(10):1432. doi: 10.3390/children9101432. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Disability	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).	Measured at 3 months post-randomization.
Secondary	Psychological distress	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.	Measured at 3 months post-randomization.
Secondary	Pain intensity	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).	Measured at 3 months post-randomization.