Chronic Pain
Conditions
Keywords
Adolescent, Cognitive Behavioral Therapy, Chronic Pain, smartphone application, internet-delivered
Brief summary
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.
Interventions
BEHAVIORALCognitive-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.
Sponsors
Connecticut Children's Medical Center
Children's Mercy Hospital Kansas City
C.S. Mott Children's Hospital
Nationwide Children's Hospital
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in activity limitations | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in pain-efficacy | 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 | 3 month followup | 1-item measure asking about change since receiving treatment |
| Change in parent behavior | 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 | 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 | 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. |
| Change in pain intensity | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Implementation, organization level | Assessed at 24 months | Provider survey regarding feasibility of implementing WebMAP and attitudes toward adoption |
| Maintenance, organization level | Assessed at 24 months | Proportion of clinics agreeing to continue using WebMAP |
| Adoption - setting level | Assessed at 24 months | Proportion of children referred to WebMAP at each clinic/Number seen in each clinic |
| Reach | Assessed at 24 months | Number of people agree to participate/Number of eligible participants referred for intervention |
Countries
United States
Outcome results
None listed