Projects

Longitudinal Studies

ADAPT (Assessing Determinants of young Adult Pain Trajectories)

PI: Caitlin Murray

Background: Although young adults experience disabling chronic pain at rates similar to older adults, there is limited research to inform interventions for this age group.

Aims: 1) Rigorously characterize pain and disability and their longitudinal impact in young adults with chronic pain. 2) Identify underlying psychosocial risk and resilience factors that drive pain and adverse developmental and health outcomes.

Study Design: Participants will be 160 young adults, ages 18-25, with chronic pain recruited from Seattle Children’s Pain Clinic and UW Medicine’s Center for Pain Relief. Participants will complete 6 online surveys about their pain, mood, health, and daily life over 2 years.

SPACE-XL (Sleep, Pain, And Cardiac Evaluation)

PI: See Wan Tham

Background: Chronic abdominal pain is common during childhood. However, the underlying causes are not well understood. There is evidence that poor sleep may lead to worse pain, in addition to poorer sympathetic and parasympathetic responses (i.e., autonomic nervous system function) and psychological functioning. Adolescents with chronic abdominal pain often experience sleep problems but there is little research on the impact of their sleep on their pain.

Aims: 1) Compare the longitudinal relationships between sleep, pain, and autonomic function in adolescents with chronic abdominal pain compared to healthy adolescents, 2) Test the role of autonomic and psychological function in the relationship between sleep and pain.

Study Design: Participants will be 200 adolescents ages 14-18, 100 with chronic abdominal pain recruited from Seattle Children’s Pain and Gastroenterology Clinics, and 100 healthy adolescents recruited from the community. Adolescents will complete 4 assessments over 1 year that include online questionnaire measures, actigraphy monitoring for sleep patterns, and lab-based evaluation of pain thresholds and heart rate variability, as a proxy for measuring autonomic function.

STAR (Surgery in Teens — Assessing Recovery)

PI: Jennifer Rabbitts; Co-I: Tonya Palermo

Background: Chronic postsurgical pain (CPSP) has been recognized as a major health concern across the lifespan. Adolescents undergoing invasive musculoskeletal surgeries, such as spinal fusion, are particularly at risk for developing CPSP. At present, little is known about the critical recovery period during the initial weeks after spinal fusion surgery when acute postsurgical pain begins to transition to CPSP, or the mechanisms contributing to this transition.

Aims: 1) Identify acute recovery patterns that predict CPSP, using short-term trajectories of pain, sleep quality, mood, and physical function over the first 30 days following spinal fusion surgery. 2) Determine the psychosocial and psychophysical mechanisms of the relationship between acute recovery and the development of chronic postsurgical pain.

Study Design: Participants will be 160 youth, ages 10-18, and scheduled for spinal fusion surgery at Seattle Children's Hospital and CHOC, along with one of their parents/caregivers. Participants will complete 5 timepoints over 1 year. Assessments include 4 online questionnaire measures for parents and youth, 30 days of brief online check-ins post-surgery, and 3 lab-based evaluations of pain thresholds for youth.

TEMPO (Teen Musculoskeletal Pain Outcomes)

PI: Amy Holley; Co-I: Tonya Palermo

Background: Musculoskeletal pain is a significant pediatric health problem. When pain becomes chronic, youth often experience negative consequences including activity limitations, poor quality of life (QOL), sleep deficiency, peer difficulties and increased depressive symptoms.

Aims: 1) Identify the contribution of the pain modulation profile to the transition from acute to chronic pain and to pain outcomes over 12 months. 2) Determine the contribution of psychosocial and behavioral vulnerabilities to longitudinal pain outcomes. 3) Test pain facilitation and pain inhibition as longitudinal mediators of the associations between psychosocial and behavioral vulnerabilities and long-term pain outcomes.

Study Design: This is a longitudinal cohort study of youth ages 11-17 with new-onset MSK pain complaints and their parents assessed comprehensively at 3 timepoints over the course of 12 months. Youth will have recently sought treatment at the emergency department or orthopedics clinic at one of two children’s hospital medical centers, Oregon Health and Science University (OHSU) or Seattle Children’s Hospital. Assessments include: online questionnaire measures, 7-day online daily diaries, actigraphy monitoring, and lab-based evaluation of pain thresholds

Clinical Trials

IMPACT-2 (Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis)

PI: Tonya Palermo

Background: Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, it is associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden.

Aims: 1) Determine the effectiveness of the Pancreatitis Pain Course in improving pancreatitis pain outcomes. 2) Explore the moderating effects of social determinants of health with changes in pain interference and severity following treatment. 3) Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of the Pancreatitis Pain Course into CPDPC Clinical Centers and the community.

Study Design: 280 adults, ages ≥ 18 years, meeting CPDPC criteria for diagnosis of either suspected or definite CP. Participants will be recruited from 9 clinics and the community. Participants will be randomized to the Pancreatitis Pain Course to learn CBT pain self-management skills or to an education control website. Patient-reported outcomes will be collected at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizations) will participate in a process evaluation to inform future implementation in clinic and community settings.

I-SPY (Intervention for Sleep and Pain in Youth)

PI: Emily Law

Background: Insomnia is a common comorbidity among adolescents with migraine. There is robust evidence showing the efficacy of cognitive-behavioral therapy for pain management intervention (CBT-Pain) for improving headache-related disability and pain in youth. However, insomnia youth with headache are rarely treated and the effects of CBT-Pain on sleep are mixed.

Aims: 1) Determine the efficacy of CBT for insomnia and the combined effect of CBT insomnia and pain interventions on reducing insomnia symptoms and headache-related disability in adolescents with migraine. 2) Offer effective, tailored self-management interventions that can address migraine and co-morbid sleep problems in adolescence and disrupt a cycle of persistent, disabling migraine from continuing into adulthood.

Study Design: 250 parent-child dyads of youth with migraine and comorbid insomnia, ages 11-17, recruited from the Seattle Children’s Neurology Clinic. In Phase 1, participants will be randomized to the CBT insomnia intervention or the online sleep education program over 6 weeks. In Phase 2, all participants will receive access to internet-delivered CBT pain intervention over 6 weeks. Participants complete 4 assessments—including online questionnaires, daily diaries, and actigraphy monitoring for sleep patterns—over 1 year.

mPRISM: Pilot trial testing mobile app-version of the Promoting Resilience in Stress Management (PRISM) intervention in Adolescents and Young Adults with Cancer

PI: Nancy Lau

Background: AYAs with cancer are at high risk of poor psychosocial outcomes. Mobile health (mHealth) behavioral interventions are cost-effective and help overcome barriers to traditional in-person care.

Aims: 1) Evaluate mPRISM for AYAs with cancer in a pilot trial. 2) Evaluate engagement and treatment dose via mobile analytics. 3) Assess barriers and facilitators to the adoption of mHealth in clinical settings.

Study Design: The sample includes 120 AYAs with cancer, ages 12-25, receiving treatment at Seattle Children’s Hospital. Participants will be randomized to psychosocial usual care plus or minus mPRISM. Using a randomized wait list design, mPRISM will be provided to the usual care arm at 3-month follow-up.

REACH (Online Social Learning Program for Parents With Irritable Bowel Syndrome: Raising Resilient Children)

PI: Tonya Palermo and Rona Levy

Background: Exposure to a parent with chronic pain in childhood is one key risk factor for pain and adverse mental and physical health outcomes among children. In particular, having a parent with Irritable Bowel Syndrome (IBS), an idiopathic chronic abdominal pain disorder, places children at greater risk for developing an abdominal pain disorder. Our own research has demonstrated that pain-specific social learning is highly influential in this intergenerational transmission. However, there is essentially no previous research that has attempted to intervene with parents to prevent illness behaviors in early childhood, when these illness behaviors often emerge and become established.

Aims: (1) Determine the efficacy of a preventive social learning and cognitive-behavioral (SLCBT) intervention delivered to parents with IBS compared to an Education condition, (2) Determine the contribution of changes in parental risk and protective factors in mediating treatment effects, (3) Determine cost savings of implementing this preventive intervention on health care expenditures and resource utilization over 18 months.

Study Design: The study design is a randomized controlled trial with two study arms, 1) attention education control, and 2) SLCBT prevention intervention. We aim to recruit 460 parents with IBS who have young children ages 4-7 years. Participants will be assessed at baseline, 6-week (immediate post-intervention), 6-month, 12-month, and 18-month follow-up periods. All study procedures will be conducted remotely using digital platforms and web-based technologies. Social media ads will be used to advertise the study and recruit participants. The primary outcome is the change in parental solicitous/protective behaviors. Secondary outcomes include parent risk and protective factors and child health and symptom outcomes. We will determine the cost savings of implementing this preventive intervention on healthcare expenditures and resource utilization over 18 months.

SurgeryPal

PI: Tonya Palermo and Jennifer Rabbitts

Background: Acute and chronic postsurgical pain (CPSP) are a major health concern across the lifespan. Adolescents undergoing invasive musculoskeletal surgeries are particularly at risk, with 20% developing CPSP and associated deterioration in health-related quality of life (HRQL). Despite research demonstrating the importance of psychological factors in the persistence of pain and opioid use following surgery, standard perioperative care in youth relies on opioids to treat pain. Non-pharmacological interventions are not accessible or widely used in this population.

Aims: 1) Determine the effectiveness of a pre-operative mHealth psychosocial intervention to improve acute pain outcomes in adolescents undergoing major musculoskeletal surgery, 2) Determine the effectiveness of a post-operative mHealth psychosocial intervention to improve chronic pain outcomes at 3 months in adolescents undergoing major musculoskeletal surgery, 3) Determine the combined effects of pre-and post-operative CBT on chronic pain outcomes, and 4) Explore mechanisms of a mHealth psychosocial intervention to prevent CPSP.

Study Design: The study design is a randomized controlled trial in 500 youth, ages 12-18 years, undergoing spinal fusion surgery and their parents. In addition to standard perioperative care, participants will be randomized using a factorial design to receive psychosocial intervention (mPATHS) or education (attention control condition) at two treatment phases, each of 4-weeks duration (pre-operative and post-operative) to test the timing of intervention delivery. Primary study outcomes are acute pain severity and opioid use assessed over the first 2 weeks after surgery, and chronic pain and HRQL at 3- and 6-month follow-ups. Secondary outcomes include psychosocial distress, sleep disturbance, and opioid misuse.

Web-MAP CP (Web-based Management of Adolescent Pain — Chronic Pancreatitis)

PI: Tonya Palermo

Background: Youth with chronic or acute recurrent pancreatitis (CP/ARP) often experience debilitating chronic or recurrent abdominal pain, however, there is no available non-pharmacological, psychosocial treatment designed for this population.

Aims: This trial aims to 1) test the efficacy of web-based CBT in youth with CP/ARP, 2) identify genetic co-variants associated with treatment response to web-based CBT, and 3) identify clinical and psychosocial factors associated with treatment benefits from web-based CBT.

Study Design: Youth ages 10-19 years old with CP/ARP and their parents/caregivers, recruited through the INSPPIRE2 cohort study and the community.