Digital Tools for Coping With Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Depression; Chronic Pain; Anxiety; Opioid Use
• Intervention / Treatment: Behavioral: myStrength

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90001
      • Craigslist
    • San Francisco, California, United States, 94016
      • Craigslist
  • Colorado
    • Denver, Colorado, United States, 80202
      • Craigslist
  • District of Columbia
    • Washington, District of Columbia, United States, 20001
      • Craigslist
  • Florida
    • Miami, Florida, United States, 33101
      • Craigslist
  • Georgia
    • Atlanta, Georgia, United States, 30301
      • Craigslist
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Craigslist
  • Minnesota
    • Minneapolis, Minnesota, United States, 55111
      • Craigslist
  • New York
    • New York, New York, United States, 10001
      • Craigslist
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19019
      • Craigslist
  • Texas
    • Houston, Texas, United States, 77001
      • Craigslist
  • Washington
    • Seattle, Washington, United States, 98101
      • Craigslist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: myStrength Intervention; 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; myStrength is a digital self-care behavioral and wellness platform
No Intervention: Waitlist Control; The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: MyStrength, Inc.
• Investigators: Principal Investigator: Krista Schladweiler, PhD, MyStrength, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (Actual): July 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: digital behavioral health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2017/06/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No