CompletedNot Applicable

Agile Development of a Digital Exposure Treatment for Youth With Chronic Musculoskeletal Pain

United States108 participantsStarted 2022-05-02

Plain-language summary

This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in one session (lasting 2 hours). In Aim 2, Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Youth ages 10-18 * Have diagnosis of chronic musculoskeletal pain (\>3months) * Have moderate to high pain interference (PROMIS Pain Interference ≥ 61) * English literate * Have access to computer, smartphone, or tablet with internet connection Exclusion Criteria: * Significant cognitive impairment (e.g., brain injury) * Significant medical or psychiatric problems that would interfere with treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Acceptability of Treatment Content - Likert Scale (Aim 1)

Timeframe: One day

Participant Satisfaction With the Intervention (Aim 2)

Timeframe: 10 weeks (assessed at discharge)

Percentage of Participants Dropped Out of Intervention (Aim 2)

Timeframe: 10 weeks (Completed at discharge)

Expectations for Treatment (Aim 2)

Timeframe: Assessed seven days after starting the intervention (7 days post-baseline)

Functional Disability (Aim 2)

Timeframe: Baseline (Day 7), Discharge (10 weeks post-baseline), and 3-month follow-up (12 weeks post-discharge)

Trial details

NCT IDNCT05079984

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-13

Results submitted2026-05-13

View on ClinicalTrials.gov More Chronic Pain trials