Digital Tools for Coping With Chronic Pain

NCT03234439 | Completed

• 1 other identifier: 2017/06/13
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 12

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.

Conditions

Chronic Pain; Depression; Anxiety; Opioid Use

Keywords

digital behavioral health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in baseline PHQ9 at 6 months

  Repeated measures over time: baseline and day 180

• Change in baseline Current Opioid Misuse Measure at 6 months

  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

  Repeated measures over time: baseline and day 180

• Change in baseline and GAD7 at 6 months

  Repeated measures over time: baseline and day 180

Study Arms (2)

myStrength Intervention

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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

Interventions

myStrength BEHAVIORAL

myStrength is a digital self-care behavioral and wellness platform

myStrength Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MyStrength, Inc.: lead

Study Sites (12)

Craigslist

Los Angeles, California, 90001, United States

Location

Craigslist

San Francisco, California, 94016, United States

Location

Craigslist

Denver, Colorado, 80202, United States

Location

Craigslist

Washington D.C., District of Columbia, 20001, United States

Location

Craigslist

Miami, Florida, 33101, United States

Location

Craigslist

Atlanta, Georgia, 30301, United States

Location

Craigslist

Boston, Massachusetts, 02111, United States

Location

Craigslist

Minneapolis, Minnesota, 55111, United States

Location

Craigslist

New York, New York, 10001, United States

Location

Craigslist

Philadelphia, Pennsylvania, 19019, United States

Location

Craigslist

Houston, Texas, 77001, United States

Location

Craigslist

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Krista Schladweiler, PhD

  MyStrength, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-arm, waitlist control trail with 1:1 randomization

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 31, 2017
• Study Start: December 8, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)