Clinical trial NCT05834725: Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain
Official title: A Pilot Randomized Controlled Trial of Resilience Coaching for Adolescents With Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Pain Syndrome
Psychological
Keywords: resilience coaching
chronic musculoskeletal pain
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2023-04-28
Enrollment: 270
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Disability
timeFrame: Measured at 3 months post-randomization.
Secondary outcomes:
measure: Psychological distress
timeFrame: Measured at 3 months post-randomization.
measure: Pain intensity
timeFrame: Measured at 3 months post-randomization.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sabrina Gmuca, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.