Digital Tools for Coping With Chronic Pain

Sponsor
MyStrength, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03234439
Collaborator
(none)
144
12
2
12.7
12
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: myStrength
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-arm, waitlist control trail with 1:1 randomizationDouble-arm, waitlist control trail with 1:1 randomization
Masking:
Single (Investigator)
Primary Purpose:
Supportive Care
Official Title:
Digital Tools for Coping With Chronic Pain
Actual Study Start Date :
Dec 8, 2017
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Change in baseline PHQ9 at 6 months [Repeated measures over time: baseline and day 180]

    Measure self-reported depression symptoms

  2. Change in baseline Current Opioid Misuse Measure at 6 months [Repeated measures over time: baseline and day 180]

    Screen for maladaptive opioid use

  3. 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

  4. Change in baseline and GAD7 at 6 months [Repeated measures over time: baseline and day 180]

    Measure self-reported anxiety symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Craigslist Los Angeles California United States 90001
2 Craigslist San Francisco California United States 94016
3 Craigslist Denver Colorado United States 80202
4 Craigslist Washington District of Columbia United States 20001
5 Craigslist Miami Florida United States 33101
6 Craigslist Atlanta Georgia United States 30301
7 Craigslist Boston Massachusetts United States 02111
8 Craigslist Minneapolis Minnesota United States 55111
9 Craigslist New York New York United States 10001
10 Craigslist Philadelphia Pennsylvania United States 19019
11 Craigslist Houston Texas United States 77001
12 Craigslist Seattle Washington United States 98101

Sponsors and Collaborators

  • MyStrength, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MyStrength, Inc.
ClinicalTrials.gov Identifier:
NCT03234439
Other Study ID Numbers:
  • 2017/06/13
First Posted:
Jul 31, 2017
Last Update Posted:
Jan 4, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by MyStrength, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2019