Anxiety, Chronic Pain, Depression, Opioid Use
Conditions
Keywords
digital behavioral health
Brief summary
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
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: 1. 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. 2. 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.
Interventions
BEHAVIORALmyStrength
myStrength is a digital self-care behavioral and wellness platform
Sponsors
MyStrength, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Intervention model description
Double-arm, waitlist control trail with 1:1 randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Study participants must be 18 years of age or older 2. 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) 3. 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) 4. Fluent in English and articulate Access to a laptop or mobile device to access email and the myStrength platform
Exclusion criteria
1. Under the age of 18 2. Chronic pain due to cancer 3. Chronic pain \<3 months or \> 9 months 4. Prior exposure to the myStrength platform 5. Self-reported history of hospitalization for mental illness or a substance use disorder 6. Receiving government benefits related to a developmental or behavioral health disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months | Repeated measures over time: baseline and day 180 | Measure ability to function in the presence of chronic pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline PHQ9 at 6 months | Repeated measures over time: baseline and day 180 | Measure self-reported depression symptoms |
| Change in baseline Current Opioid Misuse Measure at 6 months | Repeated measures over time: baseline and day 180 | Screen for maladaptive opioid use |
| Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months | Repeated measures over time: baseline and day 180 | Measure ability to function in the presence of chronic pain |
| Change in baseline and GAD7 at 6 months | Repeated measures over time: baseline and day 180 | Measure self-reported anxiety symptoms |
Countries
United States
Outcome results
None listed