Clinical trial NCT06932432: Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain
Official title: Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Keywords: EMA study
childhood onset chronic pain
Young adult
Cannabis use
Real-time predictors
Health outcomes
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-04-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seattle Children's Hospital outpatient specialty clinics

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* ages 18-25
* 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)

Primary outcomes:
measure: Momentary Pain intensity
timeFrame: Three times a day for 28 days
measure: Momentary Pain interference
timeFrame: Three times a day for 28 days
Secondary outcomes:
Other outcomes:
measure: Nightly sleep quality
timeFrame: Once a day for 28 days (morning)
measure: Momentary Social Company
timeFrame: Three times per day for 28 days
measure: Momentary Location
timeFrame: Three times a day for 28 days
measure: Momentary Fear
timeFrame: Three times a day for 28 days
measure: Momentary Positive and Negative Mood
timeFrame: Three times a day for 28 days
measure: Momentary Pain Catastrophizing
timeFrame: Three times a day for 28 days
measure: Momentary Pain Severity
timeFrame: Three times a day for 28 days
measure: Daily Self-compassion
timeFrame: Once a day for 28 days (evening)
measure: Daily Mental Defeat
timeFrame: Once a day for 28 days (evening)
measure: Daily Substance Use
timeFrame: Once a day for 28 days (evening)
measure: Daily Pain Coping
timeFrame: Once a day for 28 days (evening)
measure: Daily Pain Medication Use
timeFrame: Once a day for 28 days (evening)
measure: Daily Activity Patterns
timeFrame: Once a day for 28 days (evening)
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
References: