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Digital Exposure Treatment for Youth with Chronic Pain

N/A
Recruiting
Led By Lauren E Harrison, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have moderate to high pain interference (PROMIS Pain Interference ≥ 61)
Have diagnosis of chronic musculoskeletal pain (>3months)
Must not have
Significant medical or psychiatric problems that would interfere with treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 3-month follow-up (up to 22 weeks)
Awards & highlights

Summary

This trial will systematically develop and evaluate a new exposure treatment for youth with chronic pain, using a method that allows for rigorous evaluation at the individual level.

Who is the study for?
This trial is for young people aged 10-17 with chronic musculoskeletal pain lasting more than 3 months. They must be able to read English and have access to a digital device with internet. Participants should experience moderate to high pain interference in their daily lives. Those with significant cognitive impairments or serious medical/psychiatric issues that could affect treatment are not eligible.
What is being tested?
The study is testing a new digital program called iGET Living, designed as graded exposure treatment for managing chronic pain in youth. The effectiveness of this online intervention will be evaluated using an individual-focused experimental design over a period of six weeks, followed by outcome assessments three months post-treatment.
What are the potential side effects?
Since the intervention involves digitally delivered therapy without medication, traditional side effects are not expected. However, participants may experience discomfort or emotional distress when facing situations related to their chronic pain during the exposure exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pain significantly affects my daily activities.
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I have had muscle or joint pain for more than 3 months.
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I am between 10 and 17 years old.
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I have had muscle or joint pain for more than 3 months.
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My pain significantly affects my daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have major health or mental issues affecting treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 3-month follow-up (up to 22 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3-month follow-up (up to 22 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)
Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2)
Expectations for Treatment (Aim 2)
+3 more
Secondary study objectives
Child Fear of Pain (Aim 2)
Child Pain Acceptance (Aim 2)
Child Pain Catastrophizing (Aim 2)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Graded Exposure InterventionExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Karolinska InstitutetOTHER
1,411 Previous Clinical Trials
31,397,111 Total Patients Enrolled
9 Trials studying Chronic Pain
112,617 Patients Enrolled for Chronic Pain
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,359 Total Patients Enrolled
38 Trials studying Chronic Pain
9,313 Patients Enrolled for Chronic Pain
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,395 Total Patients Enrolled
10 Trials studying Chronic Pain
864 Patients Enrolled for Chronic Pain

Media Library

Graded exposure treatment (GET) Clinical Trial Eligibility Overview. Trial Name: NCT05079984 — N/A
Chronic Pain Research Study Groups: Graded Exposure Intervention
Chronic Pain Clinical Trial 2023: Graded exposure treatment (GET) Highlights & Side Effects. Trial Name: NCT05079984 — N/A
Graded exposure treatment (GET) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05079984 — N/A
~5 spots leftby Mar 2025
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