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Digital Tools for Coping With Chronic Pain

Primary Purpose

Chronic Pain, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
myStrength
Sponsored by
MyStrength, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring digital behavioral health

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Craigslist
  • Craigslist
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  • Craigslist

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

myStrength Intervention

Waitlist Control

Arm Description

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.

The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in baseline PHQ9 at 6 months
Measure self-reported depression symptoms
Change in baseline Current Opioid Misuse Measure at 6 months
Screen for maladaptive opioid use
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
Change in baseline and GAD7 at 6 months
Measure self-reported anxiety symptoms

Full Information

First Posted
July 24, 2017
Last Updated
January 2, 2019
Sponsor
MyStrength, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03234439
Brief Title
Digital Tools for Coping With Chronic Pain
Official Title
Digital Tools for Coping With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 8, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MyStrength, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Depression, Anxiety, Opioid Use
Keywords
digital behavioral health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-arm, waitlist control trail with 1:1 randomization
Masking
Investigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myStrength Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
The waitlist control group will gain access to the myStrength platform 60 days following the start of the study.
Intervention Type
Behavioral
Intervention Name(s)
myStrength
Intervention Description
myStrength is a digital self-care behavioral and wellness platform
Primary Outcome Measure Information:
Title
Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months
Description
Measure ability to function in the presence of chronic pain
Time Frame
Repeated measures over time: baseline and day 180
Secondary Outcome Measure Information:
Title
Change in baseline PHQ9 at 6 months
Description
Measure self-reported depression symptoms
Time Frame
Repeated measures over time: baseline and day 180
Title
Change in baseline Current Opioid Misuse Measure at 6 months
Description
Screen for maladaptive opioid use
Time Frame
Repeated measures over time: baseline and day 180
Title
Change in baseline confidence to live with chronic pain as measured by Pain Self-Efficacy Scale at 6 months
Description
Measure ability to function in the presence of chronic pain
Time Frame
Repeated measures over time: baseline and day 180
Title
Change in baseline and GAD7 at 6 months
Description
Measure self-reported anxiety symptoms
Time Frame
Repeated measures over time: baseline and day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Study participants must be 18 years of age or older 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) 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) Fluent in English and articulate Access to a laptop or mobile device to access email and the myStrength platform Exclusion Criteria: Under the age of 18 Chronic pain due to cancer Chronic pain <3 months or > 9 months Prior exposure to the myStrength platform Self-reported history of hospitalization for mental illness or a substance use disorder Receiving government benefits related to a developmental or behavioral health disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista Schladweiler, PhD
Organizational Affiliation
MyStrength, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Craigslist
City
Los Angeles
State/Province
California
ZIP/Postal Code
90001
Country
United States
Facility Name
Craigslist
City
San Francisco
State/Province
California
ZIP/Postal Code
94016
Country
United States
Facility Name
Craigslist
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
Craigslist
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Facility Name
Craigslist
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Craigslist
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
Facility Name
Craigslist
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Craigslist
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55111
Country
United States
Facility Name
Craigslist
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Craigslist
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19019
Country
United States
Facility Name
Craigslist
City
Houston
State/Province
Texas
ZIP/Postal Code
77001
Country
United States
Facility Name
Craigslist
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Tools for Coping With Chronic Pain

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