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

Trial ID or NCT#

NCT05079984

Status

recruiting iconRECRUITING

Purpose

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) and their parents (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1. Aim 2 will involve a sample (N = 20 youth, N = 20 parents) of naïve end-users. 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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 10 Years to 17 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Youth ages 10-17 - 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:
  1. - Significant cognitive impairment (e.g., brain injury) - Significant medical or psychiatric problems that would interfere with treatment

Investigator(s)

Lauren Harrison

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Contact

Lauren E Harrison, PhD
650-498-2486