Chronic PainNCT03234439
Digital Tools for Coping With Chronic Pain
A study testing myStrength in people with Chronic Pain and Depression, run by MyStrength, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Depression, Anxiety
- What is being tested?
- myStrength
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 12 sitesUnited States
- Study dates
- 8 Dec 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Craigslist
Atlanta, Georgia, 30301
Craigslist
Boston, Massachusetts, 02111
Craigslist
Denver, Colorado, 80202
Craigslist
Houston, Texas, 77001
Craigslist
Los Angeles, California, 90001
Craigslist
Miami, Florida, 33101
Craigslist
Minneapolis, Minnesota, 55111
Craigslist
New York, New York, 10001
Craigslist
Philadelphia, Pennsylvania, 19019
Craigslist
San Francisco, California, 94016
Craigslist
Seattle, Washington, 98101
Craigslist
Washington D.C., District of Columbia, 20001
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Depression, Anxiety, Opioid Use
- Being tested
- myStrength
- Keywords
- digital behavioral health
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myStrengthBehavioural
myStrength is a digital self-care behavioral and wellness platform
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Repeated measures over time: baseline and day 180
Secondary outcomes (4)
Change in baseline PHQ9 at 6 months
Measure self-reported depression symptoms
Measured: Repeated measures over time: baseline and day 180
Change in baseline Current Opioid Misuse Measure at 6 months
Screen for maladaptive opioid use
Measured: 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
Measured: Repeated measures over time: baseline and day 180
Change in baseline and GAD7 at 6 months
Measure self-reported anxiety symptoms
Measured: Repeated measures over time: baseline and day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start8 Dec 2017
- Primary completion30 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-arm, waitlist control trail with 1:1 randomization
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- MyStrength, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Schladweiler, PhD, Principal investigator, MyStrength, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234439
- Sponsor's protocol ID
- 2017/06/13
- Status last verified
- Jan 2019
- First submitted
- 24 Jul 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Tools for Coping With Chronic Pain
- ClinicalTrials.gov ID
- NCT03234439
- Acronym / sponsor ID
- 2017/06/13
- Conditions
- Chronic Pain, Depression, Anxiety, Opioid Use
- Keywords
- digital behavioral health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- MyStrength, Inc.University, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Double-arm, waitlist control trail with 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| myStrength Intervention | Experimental | Behavioral: myStrengthThe 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. |
| Waitlist Control | No intervention | –The waitlist control group will gain access to the myStrength platform 60 days following the start of the study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myStrengthmyStrength is a digital self-care behavioral and wellness platform | Behavioural | myStrength Intervention |
Primary outcome
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
4 secondary outcomes
Change in baseline PHQ9 at 6 months
Time frame: Repeated measures over time: baseline and day 180
Change in baseline Current Opioid Misuse Measure at 6 months
Time frame: 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
Time frame: Repeated measures over time: baseline and day 180
Change in baseline and GAD7 at 6 months
Time frame: Repeated measures over time: baseline and day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Schladweiler, PhD principal investigator
MyStrength, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myStrength in people with Chronic Pain and Depression, run by MyStrength, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.