NCT05079984

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

Active, enrolled NA Last updated 10 June 2025

What this trial tests

NA trial testing Graded exposure treatment (GET) in Chronic Pain in 35 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 May 2022

Primary endpoint
13 May 2025

1 October 2025

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	2 May 2022
Primary completion	13 May 2025
Estimated completion	1 October 2025
Sites	1 location across United States

Drugs / interventions tested

• Graded exposure treatment (GET)

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →
• Exposure — all drugs for Exposure →
• Adolescent Behavior — all drugs for Adolescent Behavior →
• Child Behavior — all drugs for Child Behavior →

Sponsor

Stanford University

Who can join

Adults 10 to 18, any sex, with Chronic Pain or Exposure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Digital therapeutics in the clinic.
   Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536
2. Agile development of a digital exposure treatment for youth with chronic musculoskeletal pain: protocol of a user-centred design approach and examination of feasibility and preliminary efficacy.
   Harrison LE, Webster SN, Van Orden AR, Choate E, et al · · 2022 · cited 8× · PMID 36109029 · DOI 10.1136/bmjopen-2022-065997
3. Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach.
   Schemer L, Hess CW, Van Orden AR, Birnie KA, et al · · 2023 · cited 7× · PMID 36892929 · DOI 10.2196/41292
4. Development of iGET Living, a Digital Graded Exposure Intervention for Youth With Chronic Pain: Multiphase User-Centered Design and Pilot Study.
   Harrison LE, Webster SN, Choate ES, Mayanja D, et al · · 2026 · PMID 41996537 · DOI 10.2196/89206