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Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain

Using Ecological Momentary Assessment to Develop an Adaptive Psychological Intervention for Young Adults With Chronic Pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06932432
Enrollment
50
Registered
2025-04-17
Start date
2024-12-01
Completion date
2027-12-31
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

EMA study, childhood onset chronic pain, Young adult, Cannabis use, Real-time predictors, Health outcomes

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.

Interventions

None listed

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Seattle Children's Hospital
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Momentary Pain intensityThree times a day for 28 daysOne 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 interferenceThree times a day for 28 daysTwo items from the Brief Pain Inventory will assess pain interference with enjoyment in life, and general activity. Higher scores indicate more interference.

Other

MeasureTime frameDescription
Momentary LocationThree times a day for 28 daysOne-item question to collect Where were you right before receiving this survey? in addition to GPA data with minute-to-minute mobility patterns collected via the Pathverse app
Momentary FearThree times a day for 28 daysTwo-items to assess fear associated with pain. Ratings of 0 indicate not at all and ratings of 4 indicate all the time
Momentary Positive and Negative MoodThree times a day for 28 daysTen items from the Positive and Negative Affect Schedule will measure the extent to which a positive or negative feeling is experienced on a 5-point likert scale. 1 represents 'very slightly or not at all' and 5 indicates 'extremely'.
Momentary Pain CatastrophizingThree times a day for 28 daysThree items from the Pain Catastrophizing Scale will assess the extent of catastrophic thinking due to pain. Higher scores are associated with higher amounts of pain catastrophizing.
Momentary Pain SeverityThree times a day for 28 daysThree items from the Brief Pain Inventory will measure pain intensity and pain interference on an 11-point numeric rating scale. 10 indicates 'pain as bad as you can imagine' and 'completely interferes'.
Nightly sleep qualityOnce a day for 28 days (morning)1-item from from the Insomnia Severity Index, How would you rate the quality of your sleep last night? will be rated on an 11-point NRS. 10 is equivalent to extremely good sleep and 0 indicates extremely poor sleep.
Daily Mental DefeatOnce a day for 28 days (evening)One item to assess Over the past 24 hours, how much has your pain brought back memories of times when you felt your pain had taken over your life? Response options use a 0 through 10 numeric rating scale, 0 indicates 'not at all' and 10 indicates 'Very much so'.
Daily Substance UseOnce a day for 28 days (evening)One item to gather what substances were used within the last 24 hours. Response options include: Alcohol, Tobacco, Marijuana, Other (please specify), None of the above.
Daily Pain CopingOnce a day for 28 days (evening)One item to assess pain coping strategies used in the last 24 hours. Response options include: Distracted myself (e.g., hobbies, fun activities, talk with friends), Tried to relax, Looked for support from someone (talk on the phone, spend time), Didn't let my pain get me down, Still worked to accomplish my goals, Used cold or heat compresses, Drank alcohol, Used a drug, Just accepted my pain, Other (please specify), Nothing
Daily Pain Medication UseOnce a day for 28 days (evening)Three items to assess treatments or medications received for pain in the past 24 hours
Daily Activity PatternsOnce a day for 28 days (evening)Three items to measure activity patterns over the past 24 hours. Response options use a likert scale, 0 meaning 'not at all' and 4 indicating 'all the time'.
Daily Self-compassionOnce a day for 28 days (evening)Two items, to assess how kind oneself has been to others and oneself in the past 24 hours. A rating of 0 indicates, 'not at all', and a rating of 10 means 'very much so'.
Momentary Social CompanyThree times per day for 28 days2-items to collect, Was anyone with you right before you received this survey? and Who were you with right before you received this survey?

Countries

United States

Contacts

Primary ContactCaitlin Murray, PhD
caitlin.murray@seattlechildrens.org206-884-0147

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026