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Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain

NCT ID: NCT05834725

Last Updated: 2025-12-18

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2026-06-14

Brief Summary

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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.

Detailed Description

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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 130 youth with chronic musculoskeletal pain and one of their caregivers (total number of participants = 260). 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 in which caregivers are invited to join. PRISM 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. We will also interview 10 pediatric rheumatologists at other centers to obtain their feedback on the intervention and whether it would be valuable and feasible in their clinical setting. 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.

Conditions

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Pain, Chronic Pain Syndrome Psychological

Keywords

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resilience coaching chronic musculoskeletal pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Promoting Resilience in Stress Management

Intervention Type BEHAVIORAL

Resilience coaching program.

Usual Care

Usual care consists of an individualized treatment combining physical therapy, occupational therapy and psychological counseling. This is determined by the treating provider.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

Interventions

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Promoting Resilience in Stress Management

Resilience coaching program.

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina Gmuca, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 36291374 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40694836 (View on PubMed)

Other Identifiers

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K23AR081409

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-020664

Identifier Type: -

Identifier Source: org_study_id