WebMAP Mobile Self-management of Adolescent Chronic Pain

Study Overview
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Brief Summary
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Approximately 5-8% of children report severe chronic pain and disability. Although evidence supports pain-self management as effective for reducing pain and disability, data show that most youth do not have access to this intervention. The investigative team's prior studies demonstrate that technology-delivered pain self-management (WebMAP program) can reduce barriers to care, is feasible, acceptable, and effective in reducing pain-related disability and improving anxiety and depression in youth with chronic pain. In this trial, the investigators propose an implementation project to address critical challenges in nationwide dissemination of the WebMAP pain self-management program. Using a hybrid effectiveness-implementation trial design, 8 clinics from across the U.S. will participate in a pragmatic randomized controlled trial with a stepped wedge design to sequentially implement WebMAP in the clinics following randomized usual care periods. Data will be collected from clinic records, web and app administrative tracking, and provider surveys to gather information on adoption and implementation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) public health impact framework. Individual patient-level pain outcomes will be collected from 140 patients to evaluate intervention effectiveness. The expected outcome of the project is to yield a strategic approach for a nationwide technology-delivered pain self-management intervention for youth with chronic pain that can be readily sustained in clinical settings.

Official Title
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Web-based Self-management of Adolescent Chronic Pain: National Implementation Project

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive-behavioral intervention for chronic pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child age 10-17 years, has chronic pain defined as pain present for at least 3 months, and has access to a smartphone or web-enabled device (e.g., laptop, computer, iPad). Exclusion Criteria: non-English speaking, presently in a psychiatric crisis, cognitive impairments or intellectual disabilities (has to be able to complete surveys independently), does not have access to a smartphone, computer, or internet, and is unable to read at the 5th grade level.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study will employ a stepped wedge cluster randomized design in which clinic sites are randomized sequentially to initiate the intervention. Prior to initiating patient recruitment, each of the 8 clinics will be randomized to one of two waves in the stepped wedge design. During the non-exposure periods, patients will receive usual care from the clinic.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WebMAP Mobile<br>Adolescent participants assigned to this arm will receive access to the WebMAP mobile program delivering cognitive-behavioral intervention for chronic pain. Parents of adolescents will receive access to cognitive-behavioral strategies for parents on the WebMAP parent web site. | Behavioral: Cognitive-behavioral intervention for chronic pain<br>* WebMAP is a technology-based cognitive-behavioral intervention program that teaches relaxation skills, pain coping strategies and parent behavioral and communication techniques to youth with chronic pain and their parents.<br>|
| No Intervention: Usual care<br>Participants assigned to this arm will receive usual care from the pain or specialty clinic during the non-exposure periods in the stepped wedge design. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activity limitations | The 9-item Child Activity Limitations Interview (CALI-9) will be completed on the online diary to rate perceived difficulty in completing 9 daily activities due to pain | Baseline to 3 month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Pain intensity will be measured prospectively on the 11-point Pain Numeric Rating Scale (NRS) with anchors of 0 (no pain) to 10 (worst pain possible). Average scores over 7-day assessment periods will be used in analyses. | Baseline to 3 month followup | 
| Change in anxiety and depressive symptoms | Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Emotional Distress scale is an 8-item scale of anxiety with scores ranging from 8 to 40 (higher scores indicate greater fear, anxious misery, and hyperarousal). The 8-item scale of depressive symptoms has scores ranging from 8 to 40 with higher scores indicating greater depressive symptoms. Total anxiety and total depression T-scores will be used in analyses. | Baseline to 3 month followup | 
| Change in pain-efficacy | Pain Self-Efficacy Scale-4 is a 4-item measure that assesses beliefs in carrying out activities when in pain. Total sum score ranging from 0 to 24 will be used in analysis with higher scores representing greater self-efficacy. | Baseline to 3 month followup | 
| Patient's global impression of change | 1-item measure asking about change since receiving treatment | 3 month followup | 
| Change in parent behavior | Parents report on their protective behaviors on the Adult Responses to Child Symptoms (ARCS), a 29-item scale with subscale scores for three factors, Protect, Minimize, Distract and Monitor. Each subscale is scored by computing the mean of the item responses ranging from 0 to 4 (higher scores indicate more maladaptive behaviors) | Baseline to 3 month followup | 
| Change in parent emotional distress | Parents report on their anxiety and depression symptoms on the PROMIS Adult Emotional Distress scale. This includes a 4-item scale of anxiety with scores ranging from 4 to 20 (higher scores indicate greater anxiety), and a 4-item scale of depression with scores ranging from 4 to 20 (higher scores indicate greater depression. Total anxiety and depression scale T-scores will be used in analyses. | Baseline to 3 month followup | 
| Change in insomnia severity | Insomnia Severity Index is a 7-item self-report measure. A 5-point Likert scale is used to rate each item about the severity and impact of insomnia symptoms with scores ranging from 0 to 28 (higher scores indicate greater insomnia sympotoms). A Total score will be used in analyses. | Baseline to 3 month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Cognitive Behavioral Therapy, Chronic Pain, smartphone application, internet-delivered