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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AT011593-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | 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. |
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| Intervention arm | Active Comparator | Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | will be measured at baseline, 1-month, 3-month, and 6 month intervals |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kari A Stephens, Ph.D. | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Primary Care | Seattle | Washington | 98116 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Stephens, K. A., Ma, K., Keiser, B., Prado, M., Zhang, Y., West, I., Hsu, C., Anastas, T., Zbikowski, S., Waters, D., & Masterson, J. (2024, August). Improving chronic pain through use of a digital behavioral health app. Abstract and poster presented at the American Psychological Association Annual Convention, Seattle, WA. |
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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.
Sharing will occur after the publication of the final outcomes of the study are published and will be available for up to 7 years post completion of data collection.
The requestor must provide acceptable research justification and appropriate permissions from their institutional to use the data requested for specific and detailed research purposes.
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Patients were invited to participate via direct email with a link to an interest survey with three options: eligibility survey vs request a call back vs opt out. Those eligible were directed to an e-consent form requiring confirmation vs request a call vs confirm that they no interest in participation. Patients who confirmed interest were asked to e-consent. A study coordinator counter-signed the e-consent form and follow up with any call requests, and if needed assist with consent by phone.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | 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. |
| FG001 | Intervention Arm | Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Change in score on the PROMIS Pain Interference Scale - Short Form 6b from baseline will be the primary outcome measure
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | 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. |
| BG001 | Intervention Arm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The difference in sample size between the Participant Flow section and this section is due to incomplete surveys, which were excluded from the analysis. | Posted | Mean | Standard Deviation | T-score - difference scores between arms | will be measured at baseline, 1-month, 3-month, and 6 month intervals |
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from enrollment until end of follow-up, at 6 months post baseline
Protocol deviations and data collection did not involve serious, life-threatening, or other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kari A. Stephens | University of Washington | 206-221-0349 | kstephen@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2024 | Mar 10, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Randomized control feasibility study with two arms: intervention arm vs. control arm
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| Treatment as usual | Other | 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. |
|
| 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 | will be measured at baseline, 1-month, 3-month, and 6 month intervals |
Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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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. |
| OG001 | Intervention Arm | Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual |
|
|
| Secondary | 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. | The difference in sample size between the Participant Flow section and this section is due to incomplete surveys, which were excluded from the analysis. | Posted | Mean | Standard Deviation | units on a scale | will be measured at baseline, 1-month, 3-month, and 6 month intervals |
|
|
|
| Secondary | Generalized Anxiety Disorder 7 (GAD-7) | anxiety symptom measure; scores range from 0-21; higher scores are worse | The GAD-7 measure was accidentally left off of the baseline measure for some participants at the start of the study, so the total # of GAD-7 baseline participants is lower than the total # for the other outcome measures. | Posted | Mean | Standard Deviation | units on a scale | will be measured at baseline, 1-month, 3-month, and 6 month intervals |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Intervention Arm | Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual | 0 | 49 | 0 | 49 | 0 | 49 |
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