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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 3-month follow-up (up to 22 weeks)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 3-month follow-up (up to 22 weeks)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karolinska InstitutetOTHER

1,370 Previous Clinical Trials

29,101,962 Total Patients Enrolled

9 Trials studying Chronic Pain

112,617 Patients Enrolled for Chronic Pain

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,285 Total Patients Enrolled

36 Trials studying Chronic Pain

9,163 Patients Enrolled for Chronic Pain

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,775 Total Patients Enrolled

10 Trials studying Chronic Pain

860 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in the research program?

"This experiment seeks to enrol 70 minors with chronic pain in the 10-17 age range. To be considered, applicants must satisfy specific criteria such as possess a diagnosis of musculoskeletal ache that has persisted for at least three months and have moderate or high levels of discomfort interference (PROMIS Pain Interference ≥ 61). The applicant also needs to comprehend English and access an internet enabled computer, smartphone, or tablet device."

Answered by AI

Are there any openings still available for participation in this scientific exploration?

"Data hosted on clinicaltrials.gov illustrates that this trial is actively recruiting patients, as it was initially posted on May 2nd 2022 and most recently amended on July 27th 2022."

Answered by AI

How extensive is the participation in this medical study?

"Correct. According to the information available on clinicaltrials.gov, this medical trial is still enrolling patients who match its criteria. It was published on May 2nd 2022 and amended most recently on July 27th of that year. They need 70 individuals from a single site in order to proceed with their research project."

Answered by AI

What is the primary aim of this clinical trial?

"For a period of 19 weeks, the primary outcome to be measured will be Functional Disability (Aim 2). Secondary outcomes include Parental Fear of Pain (PFOPQ), Child Pain Catastrophizing (PCS-C) and Parent Responses to Childs Pain (ARCS Protect subscale); each assessed with an appropriate 5-point Likert scale."

Answered by AI