Digital Exposure Treatment for Youth with Chronic Pain

Overseen By Laura E Simons, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairment, Medical problems, Psychiatric problems

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online treatment for young people with long-lasting muscle or joint pain. The treatment, called graded exposure therapy (GET), gradually helps participants engage in activities they might avoid due to pain, aiming to reduce pain interference in daily life. The trial begins with small group discussions to refine the program, followed by a 6-week online treatment phase. Young people aged 10-18 with chronic pain that disrupts daily activities and who can use a computer or smartphone are ideal candidates. As an unphased trial, this study provides a unique opportunity for young people to contribute to developing a potentially life-changing treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital exposure treatment is safe for youth with chronic pain?

Research has shown that graded exposure treatment (GET) is generally well-tolerated by teenagers with long-term pain. In one study, participants who received GET combined with acceptance-based exposure completed the treatment with few side effects. This approach helps reduce fear of pain by gradually introducing activities that patients might avoid due to pain concerns.

Available studies do not report major negative effects, suggesting that GET is safe for young people. Although side effects can occur with any treatment, current data indicate that GET is a promising option for managing chronic pain in youth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic pain in adolescents, like medication or physical therapy, focus on managing symptoms rather than addressing the underlying causes. However, the graded exposure treatment (GET) is unique because it targets the fear and avoidance behaviors that often accompany chronic pain, helping young patients gradually face and reduce their pain triggers. This method is delivered digitally, making it more accessible and convenient for adolescents who might struggle with frequent visits to a clinic. Researchers are excited about GET because it not only aims to reduce pain but also empowers youth to regain control over their daily activities and improve their quality of life.

What evidence suggests that this digital exposure treatment is effective for chronic pain?

Research has shown that graded exposure treatment (GET) could benefit teenagers with long-lasting pain. Studies have found that GET can reduce fear related to pain and improve daily activities. One study found that teenagers who received GET could perform daily tasks without fear of pain. In this trial, participants will receive a digitally delivered version of GET, which includes learning and exercises, with support from experts in pain psychology and physical therapy. Overall, these findings suggest that GET might effectively manage chronic pain in young people. ^{1 2 3 4 6}

Who Is on the Research Team?

Lauren E Harrison, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

English literate

My pain significantly affects my daily activities.

Access to computer, smartphone, or tablet with internet connection

Exclusion Criteria

I do not have major health or mental issues affecting treatment.

You have a severe problem with thinking and memory, like from a serious head injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Alpha Testing

Participants engage in three, two-hour focus groups over three weeks for initial testing and feedback

3 weeks

3 visits (in-person)

Baseline

Participants are enrolled in a baseline period to support SCED methodology

1-4 weeks

Treatment

Participants receive the online intervention program for graded exposure treatment

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with self-report outcome measures completed

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Graded exposure treatment (GET)

Trial Overview 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.

How Is the Trial Designed?

Group I: Graded Exposure Intervention Experimental Treatment 1 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.

Graded exposure treatment (GET) is already approved in United States for the following indications:

Approved in United States as GET Living for:

• Chronic musculoskeletal pain in adolescents

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Karolinska Institutet

Collaborator

Trials

1,510

Recruited

32,450,000+

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

Collaborator

Trials

508

Recruited

1,090,000+

Published Research Related to This Trial

A randomized controlled trial (RCT) involving 74 adolescents with chronic musculoskeletal pain is testing a new treatment called GET Living, which combines education, behavioral exposures, and parent involvement to address pain-related fear and avoidance.

The primary goal of GET Living is to reduce pain-related fear and improve functional disability, aiming to provide a targeted intervention that enhances the chances of adolescents returning to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Graded exposure treatment for adolescents with chronic pain (GET Living): Protocol for a randomized controlled trial enhanced with single case experimental design. Simons, LE., Harrison, LE., O'Brien, SF., et al.[2020]

A digital health intervention, the WebMAP Mobile app, was evaluated in a study involving 143 youth aged 10 to 17 with chronic pain, showing that participants perceived greater improvements in their condition compared to those receiving usual care.

While the intervention was found to be acceptable to parents, youth, and providers, only about 30% completed the treatment, indicating a need for further research to enhance engagement and optimize implementation of digital health solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital health psychological intervention (WebMAP Mobile) for children and adolescents with chronic pain: results of a hybrid effectiveness-implementation stepped-wedge cluster randomized trial. Palermo, TM., de la Vega, R., Murray, C., et al.[2022]

In a study involving 143 chronic pain patients, the addition of graded exposure in vivo (GEXP) to a multidisciplinary pain management program did not lead to significantly better outcomes compared to usual treatment methods.

Both treatment groups (with and without GEXP) showed significant improvements in pain intensity, fear of movement, and depression compared to a wait-list control, but no differences were found in pain disability or anxiety levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups? Bliokas, VV., Cartmill, TK., Nagy, BJ.[2007]

In a study involving 27 youth with chronic pain, the graded in vivo exposure treatment (GET Living) significantly improved fear, avoidance, and pain acceptance, with over 80% of participants showing improvement at 3- and 6-month follow-ups.

GET Living was more effective than a no-treatment baseline, particularly in reducing avoidance and increasing pain acceptance, although fear and pain catastrophizing did not show significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avoid or engage? Outcomes of graded exposure in youth with chronic pain using a sequential replicated single-case randomized design. Simons, LE., Vlaeyen, JWS., Declercq, L., et al.[2022]

In a study of 27 adolescents with chronic pain, graded exposure treatment (GET) led to significant improvements in pain-related fear, functional disability, and school functioning, with 48% of participants classified as treatment responders at discharge and 76% at the 3-month follow-up.

The use of the Reliable Change Index (RCI) allowed for a more meaningful assessment of treatment response, highlighting the importance of clinically significant changes in addition to statistical outcomes, which can help inform clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Clinically Meaningful Change in Outcomes for Youth With Chronic Pain Following Graded Exposure Treatment. Harrison, LE., Heathcote, LC., Khazendar, Z., et al.[2023]

Graded Exposure Living (GL) significantly improved pain-related fear and avoidance in adolescents with chronic musculoskeletal pain, showing positive outcomes at the 3-month follow-up in a randomized trial of 68 participants.

Both GL and Multidisciplinary Pain Management (MPM) were equally effective, with no significant differences in outcomes, indicating that both treatment approaches are credible and satisfactory for youth managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. Simons, LE., Harrison, LE., Boothroyd, DB., et al.[2023]

Citations

1. cris.maastrichtuniversity.nl cris.maastrichtuniversity.nl/files/190236502/Vlaeyen-2024-A-randomized-controlled-trial-of.pdf

A randomized controlled trial of graded exposure treatment ... The current findings support GET Living and MPM for youth with chronic pain. Keywords: Chronic pain, Adolescents, Physical therapy, Behavioral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10840960/

A randomized controlled trial of graded exposure treatment ... The current findings support GET Living and MPM for youth with chronic pain. Keywords: chronic pain, adolescents, physical therapy, behavioral ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865419302108

Graded exposure treatment for adolescents with chronic ... The primary aim is to measure changes in pain-related fear avoidance (primary outcome), and functional disability (secondary outcome) for adolescents with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03699007

GET Living: Graded Exposure Treatment for Children and ... The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31650069/

Graded exposure treatment for adolescents with chronic pain ... GET Living includes education, behavioral exposures, and parent intervention jointly delivered by pain psychology and physical therapy providers.

6. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/g/NCT03699007.html

GET Living: Graded Exposure Treatment for Children and ... The broad aim of this study is to implement and evaluate the efficacy of Graded Exposure Treatment (GET Living) to target elevated pain-related fears in ...