WebMAP Mobile Self-management of Adolescent Chronic Pain

Overview

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.

Full Title of Study: “Web-based Self-management of Adolescent Chronic Pain: National Implementation Project”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 14, 2019

Interventions

  • Behavioral: Cognitive-behavioral intervention for chronic pain
    • 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.

Arms, Groups and Cohorts

  • Experimental: WebMAP Mobile
    • 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.
  • No Intervention: Usual care
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in activity limitations
    • Time Frame: Baseline to 3 month followup
    • 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

Secondary Measures

  • Change in pain intensity
    • Time Frame: Baseline to 3 month followup
    • 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.
  • Change in anxiety and depressive symptoms
    • Time Frame: Baseline to 3 month followup
    • 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.
  • Change in pain-efficacy
    • Time Frame: Baseline to 3 month followup
    • 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.
  • Patient’s global impression of change
    • Time Frame: 3 month followup
    • 1-item measure asking about change since receiving treatment
  • Change in parent behavior
    • Time Frame: Baseline to 3 month followup
    • 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)
  • Change in parent emotional distress
    • Time Frame: Baseline to 3 month followup
    • 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.
  • Change in insomnia severity
    • Time Frame: Baseline to 3 month followup
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. child age 10-17 years, 2. has chronic pain defined as pain present for at least 3 months, and 3. has access to a smartphone or web-enabled device (e.g., laptop, computer, iPad). Exclusion Criteria:

1. non-English speaking, 2. presently in a psychiatric crisis, 3. cognitive impairments or intellectual disabilities (has to be able to complete surveys independently), 4. does not have access to a smartphone, computer, or internet, and 5. is unable to read at the 5th grade level.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seattle Children’s Hospital
  • Collaborator
    • Connecticut Children’s Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tonya Palermo, Professor, Anesthesiology and Pain Medicine – Seattle Children’s Hospital
  • Overall Official(s)
    • Tonya Palermo, PhD, Principal Investigator, Seattle Children’s Hospital

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