Digital Tools for Coping With Chronic Pain

Depression Clinical Trial

Official title:

Digital Tools for Coping With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234439
• Other study ID #: 2017/06/13
• Status: Completed
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: MyStrength, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 31, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Chronic Pain
• Depression
• Opioid Use

Intervention

Behavioral:
• myStrength
myStrength is a digital self-care behavioral and wellness platform

Locations

Country	Name	City	State
United States	Craigslist	Atlanta	Georgia
United States	Craigslist	Boston	Massachusetts
United States	Craigslist	Denver	Colorado
United States	Craigslist	Houston	Texas
United States	Craigslist	Los Angeles	California
United States	Craigslist	Miami	Florida
United States	Craigslist	Minneapolis	Minnesota
United States	Craigslist	New York	New York
United States	Craigslist	Philadelphia	Pennsylvania
United States	Craigslist	San Francisco	California
United States	Craigslist	Seattle	Washington
United States	Craigslist	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
MyStrength, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in baseline PHQ9 at 6 months	Measure self-reported depression symptoms	Repeated measures over time: baseline and day 180
Secondary	Change in baseline Current Opioid Misuse Measure at 6 months	Screen for maladaptive opioid use	Repeated measures over time: baseline and day 180
Secondary	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
Secondary	Change in baseline and GAD7 at 6 months	Measure self-reported anxiety symptoms	Repeated measures over time: baseline and day 180