Digital Tools for Coping With Chronic Pain

Study Overview
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Brief Summary
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Chronic pain is becoming increasingly more prevalent worldwide. High rates of co-morbid psychological distress are also commonly found among individuals living with chronic pain. Often requiring a multi-modal treatment approach, a growing body of literature suggests that digital behavioral health interventions and tools may serve as promising complementary options to help individuals cope with the pain.

Detailed Description
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The research objective is to evaluate the effectiveness of the myStrength product offerings, namely the chronic pain focus area, on study participants' functional well-being over time. The research questions to be answered include the following: Do study participants who are randomized to the myStrength intervention arm experience change in their self-reported ability to function, outlook on pain, and/or perception of prescription opioids. Do study participants who are randomized to the myStrength intervention arm experience change in terms of their behavioral health, such as anxiety and depression levels, during the study period. The study team hypothesizes that myStrength study participants will achieve a higher level of functioning and adopt a more positive outlook toward their pain management as compared to the waitlist control group. Self-assessments will be repeated throughout the study period to capture the inflection point of change as well as the sustainability of these changes over time.

Official Title
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Digital Tools for Coping With Chronic Pain

Conditions
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Chronic Pain, Depression, Anxiety, Opioid Use

Intervention / Treatment
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* Behavioral: myStrength


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study participants must be 18 years of age or older Self-report chronic pain lasting for at least the past 3 months but no more than 9 months (examples include lower back pain, arthritis, chronic headaches, neuropathic pain, knee pain) Must have considered, have a history of, or are currently taking a prescription opioid for chronic pain (examples oxycodone (OxyContin, Percodan, Percocet), hydrocodone (Vicodin, Lortab, Lorcet), morphine (Kadian, Avinza, MS Contin), fentanyl (Duragesic), propoxyphene (Darvon), hydromorphone (Dilaudid) Fluent in English and articulate Access to a laptop or mobile device to access email and the myStrength platform Exclusion Criteria: Under the age of 18 Chronic pain due to cancer Chronic pain <3 months or > 9 months Prior exposure to the myStrength platform Self-reported history of hospitalization for mental illness or a substance use disorder Receiving government benefits related to a developmental or behavioral health disability

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-arm, waitlist control trail with 1:1 randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myStrength Intervention<br>The myStrength intervention arm will be encouraged to utilize the chronic pain offering consisting of 6 modules. Each module has 5 activities and can take on average 5-15 minutes to complete. Study participants assigned to the myStrength intervention will have one week to complete each module. In addition to completing the required chronic pain modules, study participants in the myStrength intervention arm will have the option to also select other areas of interest and complete corresponding activities at their own pace. myStrength utilization will be recorded and analyzed. | Behavioral: myStrength<br>* myStrength is a digital self-care behavioral and wellness platform<br>|
| No Intervention: Waitlist Control<br>The waitlist control group will gain access to the myStrength platform 60 days following the start of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months | Measure ability to function in the presence of chronic pain | Repeated measures over time: baseline and day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline PHQ9 at 6 months | Measure self-reported depression symptoms | Repeated measures over time: baseline and day 180 | 
| Change in baseline Current Opioid Misuse Measure at 6 months | Screen for maladaptive opioid use | Repeated measures over time: baseline and day 180 | 
| Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months | Measure ability to function in the presence of chronic pain | Repeated measures over time: baseline and day 180 | 
| Change in baseline and GAD7 at 6 months | Measure self-reported anxiety symptoms | Repeated measures over time: baseline and day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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digital behavioral health