Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

NCT05834725 | Active Not Recruiting DMC

• 2 other identifiers: 22-020664K23AR081409
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Pain Syndrome; Psychological

Keywords

resilience coaching; chronic musculoskeletal pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychological distress

  Measured at 3 months post-randomization.

• Pain intensity

  Measured at 3 months post-randomization.

Study Arms (2)

Resilience Coaching plus Usual Care

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Usual Care OTHER

Combination of physical therapy, occupational therapy, and psychological counseling as recommended by the treating provider.

Usual Care

Promoting Resilience in Stress Management BEHAVIORAL

Resilience coaching program.

Resilience Coaching plus Usual Care

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patient participants aged 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 36291374 BACKGROUND

• Gmuca S, McGill M, Butler N, Xiao R, Cronholm PF, Young JF, Palermo TM, Weiss PF, Rosenberg AR. Resilience Coaching for Adolescent Chronic Musculoskeletal Pain: Protocol for a Pilot Randomized Controlled Trial of Promoting Resilience in Stress Management (PRISM). JMIR Res Protoc. 2025 Jul 22;14:e73385. doi: 10.2196/73385.

  PMID: 40694836 DERIVED

MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Sabrina Gmuca, MD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 8, 2023
• Primary Completion: November 2, 2025
• Study Completion (Estimated): June 14, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)