NCT06932432 · Seattle Children's Hospital
Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain
What this study is about
The goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (JITAI).
View original scientific description
The goal of this observational study is to determine real-time contextual vulnerabilities associated with pain in young adults to inform ideal treatment targets for a just-in-time adaptive intervention (JITAI). The main question it aims to answer is: -What contextual factors and vulnerabilities will predict momentary, next-day, and weekly pain severity? 50 young adults, ages 18-25 with a diagnosis of childhood-onset primary chronic pain, will complete 1) baseline questionnaires on REDCap to collect data on sociodemographics, medical history and treatment, psychological health (i.e., current mood symptoms and previous psychiatric conditions/treatment), and pain (e.g., duration, location) and 2) a 28-day EMA via mobile app to collect survey data on dynamic factors.
Primary outcome measures
Momentary Pain intensity
Time frame: Three times a day for 28 days
One item from the Brief Pain Inventory will assess momentary pain intensity (yes/no), followed by "How much pain do you feel on average?" (11-point NRS)
Momentary Pain interference
Time frame: Three times a day for 28 days
Two items from the Brief Pain Inventory will assess pain interference with enjoyment in life, and general activity. Higher scores indicate more interference.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- diagnosis of childhood-onset chronic pain who were seen for an initial evaluation at Seattle Children's Hospital outpatient specialty clinics.
Exclusion criteria
- not fluent in English
- does not have regular access to the internet and access to a smartphone device (to complete EMA questions)
- presence of chronic disease or serious medical illness (e.g., arthritis, cancer, diabetes)
- serious cognitive impairment or developmental disorder (e.g., autism, intellectual disability)
Where
- Seattle, Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2025 · Source of record for eligibility and locations