Clinical trial NCT03234439: Digital Tools for Coping With Chronic Pain
Official title: Digital Tools for Coping With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression
Anxiety
Opioid Use
Keywords: digital behavioral health
Lead sponsor: MyStrength, Inc.
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-arm, waitlist control trail with 1:1 randomization
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months
timeFrame: Repeated measures over time: baseline and day 180
Secondary outcomes:
measure: Change in baseline PHQ9 at 6 months
timeFrame: Repeated measures over time: baseline and day 180
measure: Change in baseline Current Opioid Misuse Measure at 6 months
timeFrame: Repeated measures over time: baseline and day 180
measure: Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months
timeFrame: Repeated measures over time: baseline and day 180
measure: Change in baseline and GAD7 at 6 months
timeFrame: Repeated measures over time: baseline and day 180
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Craigslist
state: California
city: San Francisco
country: United States
facility: Craigslist
state: California
city: Denver
country: United States
facility: Craigslist
state: Colorado
city: Washington
country: United States
facility: Craigslist
state: District of Columbia
city: Miami
country: United States
facility: Craigslist
state: Florida
city: Atlanta
country: United States
facility: Craigslist
state: Georgia
city: Boston
country: United States
facility: Craigslist
state: Massachusetts
city: Minneapolis
country: United States
facility: Craigslist
state: Minnesota
city: New York
country: United States
facility: Craigslist
state: New York
city: Philadelphia
country: United States
facility: Craigslist
state: Pennsylvania
city: Houston
country: United States
facility: Craigslist
state: Texas
city: Seattle
country: United States
facility: Craigslist
state: Washington
Study officials:
affiliation: MyStrength, Inc.
name: Krista Schladweiler, PhD
role: PRINCIPAL_INVESTIGATOR
References: