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

November 20, 2023 updated by: Lauren Harrison, Stanford University

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) and their parents (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, N = 20 parents) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Menlo Park, California, United States, 94025
        • Recruiting
        • Pediatric Pain Management Clinic
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Youth ages 10-17
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Graded Exposure 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.
Behavioral: Graded exposure treatment (GET)
Graded-exposure is a theory driven, individually tailored, and evidenced based behavioral intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Likert Scale (Aim 1 and Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Participant-rated acceptability measured on 5-point Likert scale. Range 0-4 (higher scores indicate more acceptable). Questionnaire will be administered to youth with chronic pain and their parents.
Baseline through 3-month follow-up (up to 22 weeks)
Assessment of Acceptability of Treatment Content and Digital Delivery Questionnaire - Participant Responses (Aim 1 and Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Acceptability will be assessed qualitatively through participant responses to open-ended questions related to acceptability, ease of use, comprehensibility, and suggestions for improvement. Responses will be assessed categorically by the investigator. Questionnaire will be administered to youth with chronic pain and their parents.
Baseline through 3-month follow-up (up to 22 weeks)
Participant Satisfaction with the Intervention (Aim 1 and Aim 2)
Time Frame: 19 weeks (Assessed at the end of treatment)
Treatment satisfaction at the end of treatment will be evaluated by examining mean satisfaction scores on an adapted version of the Pain Service Satisfaction Test (PSST, McCracken et al., 1997). The PSST consists of 23 items rated on a 5-point Likert Scale (0 = not at all satisfied to 4 = very satisfied) and assesses the patient and parent's experience of the intervention. Scores range from 0-92. A score greater than/equal to 40 of 60 (satisfied to very satisfied) will indicate high levels of satisfaction with the intervention content.
19 weeks (Assessed at the end of treatment)
Percentage of Participants Dropped Out of Intervention (Aim 2)
Time Frame: 19 weeks (Assessed at the end of treatment)
As a measure of treatment adherence, we will calculate the percentage of participants who drop out or withdraw from the intervention prior to completion of the intervention.
19 weeks (Assessed at the end of treatment)
Expectations for Treatment (Aim 2)
Time Frame: Baseline (up to 2 minutes to complete the survey)
Participants (child) and parent expectations for treatment will be measured by the Treatment Expectancy and Creditability, Borkovec & Nau, 1972). The TEC is comprised of 6 items rated on a 0 to 10 Likert-scale assessing expectations related to the effectiveness of the current treatment. The TEC is completed by the patient at the end of the first treatment session. Higher scores indicate greater expectations for treatment effectiveness.
Baseline (up to 2 minutes to complete the survey)
Functional Disability (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Functional disability will be assessed using the Functional Disability Inventory (FDI, Walker & Greene, 1991), a 15-item self-report measure of perceived difficulty in performing activities in school, home, physical, and social contexts. Items are rated on a 5-point Likert scale ranging from 0 (no trouble) to 4 (impossible). Items are summed to create a total score (range 0-60), with higher scores indicating greater disability.
Baseline through 3-month follow-up (up to 22 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child Fear of Pain (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Fear of Pain Questionnaire- Child (FOPQ-C, Simons et al., 2011) consists of 24 items, with each item rated on a 5-point Likert scale (0 = "strongly disagree" to 4 = "strongly agree"). The FOPQ-C contains two subscales: Fear of Pain (11 items) and Avoidance of Activities (13 items). Total score is derived by summing subscale items, with higher scores indicating greater pain related fear (score range 0-44) and avoidance of activities (score range 0-52).
Baseline through 3-month follow-up (up to 22 weeks)
Parental Fear of Pain (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
The Parent Fear of Pain Questionnaire (PFOPQ, Simons et al., 2015) assesses parent's fear associated with their child's pain experiences. The PFOPQ contains 23 items assessed on a 5-point Likert scale (0 = "strongly disagree" to 4 "strongly agree"). Items are summed to create a total score (0-92), with higher scores indicated greater parent fear associated with their child's pain.
Baseline through 3-month follow-up (up to 22 weeks)
Child Pain Catastrophizing (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
The Pain Catastrophizing Scale -Child Version (PCS-C, Crombez et al., 2003) assesses negative cognitions associated with pain. The PCS-C is comprised of 13-items rated on a 5-point Likert scale (0= "not at all true" to 4 "very true"). A total score (0-52) is obtained by summing all items. Higher scores indicate higher levels of catastrophic thinking.
Baseline through 3-month follow-up (up to 22 weeks)
Parent Pain Catastrophizing (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Pain Catastrophizing Scale-Parent Version (PCS-P, Goubert et al., 2006) assesses parents' negative cognitions associated with their child's pain. It is comprised of 13 items rated on a 5-point Likert scale (0 = "not true at all" to 4 = "very true"). A total score (0-52) is derived by summing items, with higher scores indicating higher levels of catastrophic thinking.
Baseline through 3-month follow-up (up to 22 weeks)
Child Pain Acceptance (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Child report on the Chronic Pain Acceptance Questionnaire for Adolescents-short form (CPAQ-A8, Gauntlett-Gilbert et al., 2018) will be used to assess pain acceptance in the child. The CPAQ-A8 is an 8-item measure consisting of two subscales: Activity Engagement (4 items) and Pain Willingness (4 items). Items are rated on a 5-point Likert scale ranging from 0 (Never True) to 4 (Always True) and yield a total score for each subscale ranging from 0-16. Higher scores indicate greater Activity Engagement and greater Pain Willingness .
Baseline through 3-month follow-up (up to 22 weeks)
Parent Psychological Flexibility (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
The Parent Psychological Flexibility Questionnaire (PPFQ-10, Timmers et al., 2019) is a 10-item parent self-report questionnaire assessing a parent's ability to accept their own distress and respond adaptively and flexibly to their child's pain. Items are rated on a 5-point Likert scale (0= " never true" to 4 = "always true") and are summed to create a total score, ranging from 0 - 40. Higher scores indicate greater parent psychological flexibility.
Baseline through 3-month follow-up (up to 22 weeks)
Parent Responses to Childs Pain (Aim 2)
Time Frame: Baseline through 3-month follow-up (up to 22 weeks)
Adult Responses to Children's Symptoms (ARCS, Claar et al., 2010) assesses parents' behavioral responses to children's pain behaviors. The Protect subscale (13 items) will be utilized in this study. The Protect scale refers to protective parental behavior, such as giving the child special attention and limiting the child's normal activities and responsibilities. All items are rated on a 5-point Likert scale (0 = "never" to 4 "always"), and are averaged to create a total score ranging from 0-4. Hiigher scores indicating greater use of a particular type of response to their child's pain.
Baseline through 3-month follow-up (up to 22 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

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

Investigators

  • Principal Investigator: Lauren E Harrison, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53323
  • 1K23AR079608-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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