Resilience Coaching for Adolescent Chronic Pain

Overseen By Mackenzie McGill, MD, MSCE

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Head pain, Abdominal pain, CRPS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on resilience coaching for chronic pain, so it's best to discuss your medications with the trial coordinators.

Is resilience coaching safe for adolescents with chronic pain?

The study on Promoting Resilience in Stress Management (PRISM) for adolescents with chronic musculoskeletal pain found the program to be feasible and acceptable, with high satisfaction rates among participants, suggesting it is generally safe for use in this population. ^{1 2 3 4 5}

How is the PRISM treatment different from other treatments for adolescent chronic pain?

PRISM is unique because it focuses on resilience coaching, teaching skills like stress management, goal-setting, and cognitive reframing (changing negative thought patterns), which are not typically emphasized in standard chronic pain treatments. This approach aims to improve psychological resilience and overall well-being, rather than just addressing pain symptoms. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Promoting Resilience in Stress Management (PRISM) for adolescent chronic pain?

The PRISM program, which focuses on stress management and resilience skills, showed improvements in resilience, functional disability, and psychological distress among adolescents with chronic musculoskeletal pain in a pilot trial, suggesting it may be beneficial for managing chronic pain. ^{1 2 8 9 10}

Who Is on the Research Team?

Sabrina Gmuca, MD MSCE

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

Adolescents aged 12-17 with chronic musculoskeletal pain, which includes bone, joint, muscle or related soft tissue pain lasting more than 3 months. They must have a caregiver to participate alongside them and both should primarily speak English. Those already receiving cognitive behavioral therapy or diagnosed with complex regional pain syndrome are excluded.

Inclusion Criteria

My daily activities are affected by pain.

Willing to provide informed consent/assent

One caregiver willing to consent and participate in dyad

Exclusion Criteria

I experience pain only in my head or abdomen.

I am currently undergoing cognitive behavioral therapy.

I cannot give consent and do not have a legal guardian to do so for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resilience coaching through the PRISM program, consisting of 4 required sessions and one optional session over 12 weeks

12 weeks

4 visits (virtual), 1 optional session

Follow-up

Participants are monitored for improvements in functional disability, psychological distress, and pain intensity

9 months

Survey measures at baseline, 3 months, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Promoting Resilience in Stress Management (PRISM)
• Usual Care

Trial Overview The trial is testing the effectiveness of resilience coaching (PRISM) for teens with chronic musculoskeletal pain compared to usual care. It aims to see if PRISM can better improve how these adolescents cope with disability, psychological distress, and pain intensity.

How Is the Trial Designed?

Group I: Resilience Coaching plus Usual Care Experimental Treatment 1 Intervention

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 II: Usual Care Active Control 1 Intervention

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

Promoting Resilience in Stress Management (PRISM) is already approved in United States for the following indications:

Approved in United States as PRISM for:

• Chronic Musculoskeletal Pain in Adolescents

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

The PRISM resilience coaching program is feasible and well-accepted among youth aged 12-17 with chronic musculoskeletal pain, with an 81% completion rate and high satisfaction scores (mean 4.3 out of 5).

Participants showed significant improvements in resilience, functional disability, and psychological distress after the intervention, indicating potential benefits that merit further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability of Resilience Coaching for Adolescent Chronic Musculoskeletal Pain: A Single-Arm Pilot Trial. Gmuca, S., Weiss, PF., McGill, M., et al.[2023]

In a study of 58 children and adolescents with chronic pain, fear of pain and pain catastrophizing were found to negatively impact their functioning, while optimism emerged as a unique predictor of better quality of life.

Optimism may serve as a protective factor, helping to reduce the negative effects of pain-related fear and catastrophizing on the overall functioning of youth with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and Resilience in Pediatric Chronic Pain: Exploring the Protective Role of Optimism. Cousins, LA., Cohen, LL., Venable, C.[2018]

In a study of 770 youth aged 8-18 with chronic pain, 82% reported experiencing at least one stressor, highlighting the prevalence of stressors in this population.

The presence of multiple stressors was linked to increased anxiety and disability, as well as decreased quality of life, indicating that addressing stressors may be crucial for improving outcomes in youth with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship between Stressors and Pain-Related Clinical Outcomes in Pediatric Chronic Pain Patients. Jagpal, A., Hainsworth, K., Galijot, R., et al.[2021]

In a study of 122 youth aged 10 to 17 with chronic pain, factors like youth pain acceptance and self-efficacy, along with parent psychological flexibility, were found to be strongly linked to improved quality of life (QOL) for the youth.

Parental protectiveness was identified as a significant mediator between parental psychological flexibility and youth QOL, suggesting that how parents respond to their child's pain can impact the child's overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Youth With Chronic Pain: An Examination of Youth and Parent Resilience and Risk Factors. Lee, S., McMurtry, CM., Summers, C., et al.[2021]

Chronic pain in adolescents leads to significant disability and distress, impacting their quality of life and that of their families, highlighting the need for effective treatment options.

Despite advancements in assessment methods and treatment programs over the past decade, the evidence for effective treatments remains limited, indicating a critical need for new clinical trials and better access to existing evidence-supported therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent chronic pain and disability: A review of the current evidence in assessment and treatment. Eccleston, C., Clinch, J.[2021]

The Peds-CHOIR system, designed for pediatric chronic pain management, allows for real-time data collection from patients (aged 8-17) and their caregivers, enhancing both clinical decision-making and research capabilities.

Initial findings from 352 patients showed significant impairments in physical, psychological, and social domains, with caregivers reporting greater internal experience impairments than patients, highlighting the importance of capturing both perspectives for tailored treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric-Collaborative Health Outcomes Information Registry (Peds-CHOIR): a learning health system to guide pediatric pain research and treatment. Bhandari, RP., Feinstein, AB., Huestis, SE., et al.[2022]

Research indicates that family characteristics, particularly family dysfunction, can negatively impact resilience in children with Juvenile Idiopathic Arthritis (JIA), highlighting the importance of family dynamics in managing chronic pain.

Individual resilience factors such as psychological flexibility, self-efficacy, and perceived social support are associated with better health-related quality of life and functional outcomes in children with JIA, suggesting that enhancing these traits could improve coping strategies for pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child and Family Adaptation to Juvenile Idiopathic Arthritis-A Systematic Review of the Role of Resilience Resources and Mechanisms. Hynes, L., Saetes, S., McGuire, B., et al.[2020]

In a study of 145 adolescents with chronic pain, benefit finding—recognizing positive aspects despite adversity—was linked to lower pain intensity and better quality of life, suggesting it may help improve outcomes for these youth.

Benefit finding also correlated with internalizing mental health symptoms like anxiety and depression, indicating that fostering this mindset could be important for managing both emotional and physical challenges in young people with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding Silver Linings: A Preliminary Examination of Benefit Finding in Youth With Chronic Pain. Soltani, S., Neville, A., Hurtubise, K., et al.[2022]

In a study of 116 children and adolescents with chronic pain, 37% reported comorbid psychiatric disorders, significantly higher than the expected 14% in the general population, highlighting the mental health challenges faced by these patients.

Resilience, demonstrated through prosocial behaviors, was linked to fewer psychiatric symptoms, suggesting that fostering resilience may be an important aspect of treatment for young people with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Chronic Pain, Resilience and Psychiatric Comorbidity in Canada: A Retrospective, Comparative Analysis. Young, MA., Anang, P., Gavalova, A.[2023]

The 'Coping with Pain in School' (CPS) intervention was found to be feasible and generally acceptable to families, with improvements noted in pain severity, some aspects of depression, and school attendance among the 40 participating adolescents after one month.

Despite its promise, the study highlighted challenges in participant enrollment, indicating a need for further research to refine the intervention and better address the role of depression in adolescents with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a group intervention to improve school functioning in adolescents with chronic pain and depressive symptoms: a study of feasibility and preliminary efficacy. Logan, DE., Simons, LE.[2011]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability of Resilience Coaching for Adolescent Chronic Musculoskeletal Pain: A Single-Arm Pilot Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Risk and Resilience in Pediatric Chronic Pain: Exploring the Protective Role of Optimism. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Relationship between Stressors and Pain-Related Clinical Outcomes in Pediatric Chronic Pain Patients. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of Life in Youth With Chronic Pain: An Examination of Youth and Parent Resilience and Risk Factors. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Adolescent chronic pain and disability: A review of the current evidence in assessment and treatment. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pediatric-Collaborative Health Outcomes Information Registry (Peds-CHOIR): a learning health system to guide pediatric pain research and treatment. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Child and Family Adaptation to Juvenile Idiopathic Arthritis-A Systematic Review of the Role of Resilience Resources and Mechanisms. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Finding Silver Linings: A Preliminary Examination of Benefit Finding in Youth With Chronic Pain. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pediatric Chronic Pain, Resilience and Psychiatric Comorbidity in Canada: A Retrospective, Comparative Analysis. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Development of a group intervention to improve school functioning in adolescents with chronic pain and depressive symptoms: a study of feasibility and preliminary efficacy. [2011]