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

Stanford University

Status: Active, not recruiting

Conditions: Exposure; Child Behavior; Chronic Pain; Adolescent Behavior

Treatments: Behavioral: Graded exposure treatment (GET)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05079984

1K23AR079608-01 (U.S. NIH Grant/Contract)

53323

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Graded Exposure Intervention

Experimental group

Description:

For Aim 2, adolescents with chronic pain will be enrolled in a single-arm feasibility trial examining acceptability, feasibility, and preliminary effectiveness of a novel, digitally delivered, graded exposure treatment.

Treatment:

Behavioral: Graded exposure treatment (GET)