A Phase 2 interventional study of 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app and Treatment as usual in Chronic Pain, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 108 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
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Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
Treatment as usual arm entails the patients continuing to receive care from their primary care provider and any specialists they choose to get involved in their care.
Other: Treatment as usual
Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual
Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app
2Morrow Chronic Pain Self-Management Program is delivered via a mobile app that engaged patients in evidenced based psychotherapy for chronic pain, including Acceptance and Commitment Therapy and Cognitive Behavioral Therapy based activities, to improve a patient's pain self management. The mobile app also offers the ability to track activities, screen for other problems, support for communicating with medical providers, and access a coach via texting.
Treatment as usual entails continuing with treatment for chronic pain with the patient's primary care provider and any potential specialists they choose to engage with.
PROMIS Pain Interference Scale - Short Form 6b
This self-report questionnaire consists of is a six-item that assesses the impact of pain on various aspects of a person's life (e.g., social, cognitive, emotional, physical and recreational activities) over the last 7 days. Responses are scored using a 5-point ordinal rating scale from 1 to 5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Raw score totals are converted to T-score using the scoring manual. T-score of 50 is the mean for the U.S. general population with a standard deviation of 10; the higher the T-score, the worse the pain interference.
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Patient Health Questionnaire 9 (PHQ-9)
This self-report questionnaire consists of 9 items assessing depressive symptoms consistent with criteria for Major Depressive Disorder over the past two weeks. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome). A typical cut-off score for probable depression is ≥ 10 points. The measure has demonstrated strong psychometric properties, including high levels of sensitivity and specificity for identifying major depressive disorder.
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Generalized Anxiety Disorder 7 (GAD-7)
anxiety symptom measure; scores range from 0-21; higher scores are worse
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Eligibility: aged \>=18, pain experience current and present for \>=3 months, \>=1 ICD code for common pain related condition, \>=2 primary care visits within last 12 months at time of recruitment, PROMIS Pain Interference Short Form 6b T-score \>=55, daily smartphone access, ability to download an app, willingness to engage in a 3-month chronic pain self-management program administered via an app, speak English, and consented. Exclusions: cancer pain surgery within 3 months, pregnant, on hospice.
| Milestone | Treatment as Usual | Intervention Arm |
|---|---|---|
| Started | 43 | 49 |
| Completed | 40 | 38 |
| Not completed | 3 | 11 |
This self-report questionnaire consists of is a six-item that assesses the impact of pain on various aspects of a person's life (e.g., social, cognitive, emotional, physical and recreational activities) over the last 7 days. Responses are scored using a 5-point ordinal rating scale from 1 to 5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Raw score totals are converted to T-score using the scoring manual. T-score of 50 is the mean for the U.S. general population with a standard deviation of 10; the higher the T-score, the worse the pain interference.
| T-score - difference scores between arms | Treatment as Usual | Intervention Arm |
|---|---|---|
| baseline difference scores | 62.1 ± 5.5 | 62.1 ± 4.2 |
| 1-month different scores | 62.8 ± 5.7 | 60.8 ± 5.6 |
| 3-month difference | 61.9 ± 6.2 | 61.2 ± 5.6 |
| 6-month difference | 61.0 ± 6.1 | 59.9 ± 5.7 |
This self-report questionnaire consists of 9 items assessing depressive symptoms consistent with criteria for Major Depressive Disorder over the past two weeks. Each item is rated on a 4-point Likert scale (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Item scores are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome). A typical cut-off score for probable depression is ≥ 10 points. The measure has demonstrated strong psychometric properties, including high levels of sensitivity and specificity for identifying major depressive disorder.
| units on a scale | Treatment as Usual | Intervention Arm |
|---|---|---|
| baseline difference | 8.2 ± 6.1 | 8.5 ± 5.1 |
| 1-month difference | 8.3 ± 6.4 | 8.7 ± 5.3 |
| 3-month difference | 8.8 ± 5.8 | 7.9 ± 5.9 |
| 6-month difference | 7.7 ± 5.7 | 8.6 ± 5.4 |
anxiety symptom measure; scores range from 0-21; higher scores are worse
| units on a scale | Treatment as Usual | Intervention Arm |
|---|---|---|
| baseline difference | 6.6 ± 5.6 | 8.2 ± 5.3 |
| 1-month difference | 6.9 ± 6.1 | 8.0 ± 5.5 |
| 3-month difference | 6.8 ± 5.2 | 7.2 ± 5.9 |
| 6-month difference | 6.3 ± 57 | 7.0 ± 5.4 |
Collected over from enrollment until end of follow-up, at 6 months post baseline. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Intervention Arm | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
Change in score on the PROMIS Pain Interference Scale - Short Form 6b from baseline will be the primary outcome measure
| Age, Categorical(Participants) | Treatment as Usual | Intervention Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 38 | 72 |
| >=65 years | 9 | 11 | 20 |
| Sex/Gender, Customized(Participants) | Treatment as Usual | Intervention Arm | Total |
|---|---|---|---|
| Gender | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment as Usual | Intervention Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 7 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 6 | 7 | 13 |
| White | 22 | 21 | 43 |
| More than one race | 9 | 8 | 17 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual | Intervention Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 9 | 19 |
| Not Hispanic or Latino | 32 | 40 | 72 |
| Unknown or Not Reported | 1 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be made upon request after evaluation for appropriateness by principal investigator as an appropriate research request by individuals seeking to do further research. All data will be de-identified to protect participant privacy.
Supporting information: Study protocol, Sap
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