Chronic PainPhase 2NCT06000007
Digital Therapeutic for Chronic Pain Feasibility Study
A Phase 2 study testing 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app and Treatment as usual in people with Chronic Pain, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app and Treatment as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2023to 30 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18 years old
- at least one ICD pain related diagnosis noted in the electronic health record (EHR)
- at least 2 visits in a primary care clinic with at least one in the last 12 months
- willing to use a mobile app in English
- T-score for the PROMIS brief pain inventory of >= 55
- access to a smartphone
- willing to download and use a mobile app daily
Who cannot join
- current cancer related diagnosis (to exclude cancer related chronic pain)
- plans for surgery in next 3 months
- pregnant
- currently receiving hospice care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Primary Care
Seattle, Washington, 98116
About this study
Official title: Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients With Chronic Pain
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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Being tested
- 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app, Treatment as usual
- Keywords
- chronic pain, primary care, digital therapeutic, mobile app, pain function, pain interference, psychotherapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile appDevice
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 usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treatment as usual |
| Intervention arm | Active comparator | Intervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual Receives: Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Secondary outcomes (2)
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.
Measured: 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
Measured: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Aug 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control feasibility study with two arms: intervention arm vs. control arm
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kari Stephens, University of Washington
- Investigators
- Kari A Stephens, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000007
- Sponsor's protocol ID
- STUDY00016340
- Other IDs
- 1R44AT011593-01
- Status last verified
- Jul 2025
- First submitted
- 10 Aug 2023
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
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.
Zbikowski SM, Masterson J, Burrola-Mendez Y, Hsu C, Ma KPK, Zhang Y, Waters D, Stephens KA. Participant Engagement With a Digital Behavioral Health App for Chronic Pain: Descriptive Secondary Analysis of a Feasibility Randomized Controlled Trial. JMIR Hum Factors. 2026 Apr 9;13:e88122. doi: 10.2196/88122.
PubMed 41955535
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT06000007
- Acronym / sponsor ID
- STUDY00016340
- Conditions
- Chronic Pain
- Keywords
- chronic pain, primary care, digital therapeutic, mobile app, pain function, pain interference, psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 31 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control feasibility study with two arms: intervention arm vs. control arm
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment 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. |
| Intervention arm | Active comparator | Device: 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile appIntervention arm includes access to the digital therapeutic mobile app in addition to treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >=18 years old
- at least one ICD pain related diagnosis noted in the electronic health record (EHR)
- at least 2 visits in a primary care clinic with at least one in the last 12 months
- willing to use a mobile app in English
- T-score for the PROMIS brief pain inventory of >= 55
Key exclusion criteria (4 listed)
- current cancer related diagnosis (to exclude cancer related chronic pain)
- plans for surgery in next 3 months
- pregnant
- currently receiving hospice care
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 |
|---|---|---|
| 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app2Morrow 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. | Device | Intervention arm |
| Treatment as usualTreatment 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. | Other | Treatment as usual |
Primary outcome
PROMIS Pain Interference Scale - Short Form 6b
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
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.
2 secondary outcomes
Patient Health Questionnaire 9 (PHQ-9)
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationStephens, 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.
- Derived from this study: PubMed 41955535Zbikowski SM, Masterson J, Burrola-Mendez Y, Hsu C, Ma KPK, Zhang Y, Waters D, Stephens KA. Participant Engagement With a Digital Behavioral Health App for Chronic Pain: Descriptive Secondary Analysis of a Feasibility Randomized Controlled Trial. JMIR Hum Factors. 2026 Apr 9;13:e88122. doi: 10.2196/88122.
- Individual participant dataSharing planned: 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.
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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.
Kari A Stephens, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2Morrow Chronic Pain Self-Management Program - digital therapeutic mobile app and Treatment as usual in people with Chronic Pain, run by University of Washington at 1 site 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 7 inclusion and 4 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PROMIS Pain Interference Scale - Short Form 6b (time frame: will be measured at baseline, 1-month, 3-month, and 6 month intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000007, which also lists 2 linked publications.
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 31 Mar 2026.