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ACTIVE NOT RECRUITING
NCT05079984
NA

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

Sponsor: Stanford University

View on ClinicalTrials.gov

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 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) 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.

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2022-05-02

Completion Date

2025-10-01

Last Updated

2025-06-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

Graded exposure treatment (GET)

Graded-exposure is a theory driven, individually tailored, and evidenced based behavioral intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities.

Locations (1)

Pediatric Pain Management Clinic

Menlo Park, California, United States