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OpenTrials
Completed

NCT Number: NCT03234439

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.

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Key information

Conditions

Chronic Pain Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craigslist, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

myStrength

Behavioral

myStrength is a digital self-care behavioral and wellness platform

Primary outcomes

  1. Change in baseline thoughts and feelings about chronic pain as measured by Global Pain Scale at 6 months

    Time frame: Repeated measures over time: baseline and day 180

    Measure ability to function in the presence of chronic pain

Secondary outcomes

  1. Change in baseline PHQ9 at 6 months

    Time frame: Repeated measures over time: baseline and day 180

    Measure self-reported depression symptoms

  2. Change in baseline Current Opioid Misuse Measure at 6 months

    Time frame: 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

    Time frame: 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

    Time frame: Repeated measures over time: baseline and day 180

    Measure self-reported anxiety symptoms

Sponsors and collaborators

Lead sponsor

MyStrength, Inc.

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2017
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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