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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myStrength Intervention | Experimental | 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. |
|
| Waitlist Control | No Intervention | The waitlist control group will gain access to the myStrength platform 60 days following the start of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myStrength | Behavioral | myStrength is a digital self-care behavioral and wellness platform |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krista Schladweiler, PhD | MyStrength, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Craigslist | Los Angeles | California | 90001 | United States | ||
| Craigslist |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double-arm, waitlist control trail with 1:1 randomization
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| 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 |
| San Francisco |
| California |
| 94016 |
| United States |
| Craigslist | Denver | Colorado | 80202 | United States |
| Craigslist | Washington D.C. | District of Columbia | 20001 | United States |
| Craigslist | Miami | Florida | 33101 | United States |
| Craigslist | Atlanta | Georgia | 30301 | United States |
| Craigslist | Boston | Massachusetts | 02111 | United States |
| Craigslist | Minneapolis | Minnesota | 55111 | United States |
| Craigslist | New York | New York | 10001 | United States |
| Craigslist | Philadelphia | Pennsylvania | 19019 | United States |
| Craigslist | Houston | Texas | 77001 | United States |
| Craigslist | Seattle | Washington | 98101 | United States |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |