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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Graded Exposure Treatment Living (GET Living) for youth with chronic pain?

Research shows that GET Living helps improve functioning in youth with chronic pain by reducing fear and avoidance of activities. In studies, over 80% of participants showed improvement in these areas at follow-up, supporting its effectiveness. ^{1 2 3 4 5}

Is Digital Exposure Treatment for Youth with Chronic Pain safe?

Research on Graded Exposure Treatment (GET) and its variations, like GET Living, shows that it is generally safe for youth with chronic pain. Participants reported high satisfaction with the treatment, and no significant safety concerns were noted in the studies. ^{1 2 3 4 6}

How is the graded exposure treatment (GET Living) different from other treatments for chronic pain in youth?

Graded exposure treatment (GET Living) is unique because it focuses on gradually exposing youth to activities they fear and avoid due to pain, aiming to reduce fear and improve function. Unlike other treatments that may focus on pain management through cognitive behavioral therapy or physical therapy alone, GET Living combines these elements with acceptance-based exposure to specifically target pain-related fear and avoidance. ^{1 2 3 4 5}

Research Team

Lauren E Harrison, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of graded exposure treatment (GET living) for adolescents with chronic pain. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Measuring Clinically Meaningful Change in Outcomes for Youth With Chronic Pain Following Graded Exposure Treatment. [2023]

3. United States 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. [2022]

4. Netherlands 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. [2020]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Does systematic graded exposure in vivo enhance outcomes in multidisciplinary chronic pain management groups? [2007]