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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH131989 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Duke University | OTHER |
| Wysa | INDUSTRY |
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The purpose of this research study is to refine customized in-app notifications in order to optimize users' experience with a mobile app called Wysa for Chronic Pain. This app is designed to support people who have chronic pain and who also experience symptoms of depression and/or anxiety. This version of the app is not currently available to the public. Eligible participants will be asked to download and use the Wysa for Chronic Pain study app for several weeks, and to use it as they normally would if they were not part of a research study. At the beginning and end of the study period, participants will be asked to complete brief surveys about their mood, pain, physical function, and sleep. Additionally, a few participants will be asked to share their experience with the study app at the end of the research study in a casual interview using a secure audio/video recorded call. Participating in the interview portion is optional.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wysa for Chronic Pain + JITAIs | Experimental | Participants assigned to the experimental arm will receive access to the Wysa for Chronic Pain app, and the novel JITAIs that are being tested in this study will be incorporated into the app experience. In an initial 4-week pilot trial, participants in this arm will receive the JITAIs every time the decision rule (i.e., "trigger criteria") is satisfied for that respective JITAI. In subsequent 12-week micro-randomized trials, every time the decision rule for a JITAI is satisfied, participants in this arm will be randomized to receive (versus not receive) the respective JITAI. |
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| Wysa for Chronic Pain without JITAIs | Active Comparator | Participants assigned to the control arm will receive access to the Wysa for Chronic Pain app, but the novel JITAIs that are being tested in this study will not be incorporated into the app experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Just-In-Time Adaptive Interventions (JITAIs) | Other | JITAIs are digital interventions that aim to deliver support to a user when the person is most in need and receptive to the intervention. In this study, multiple JITAIs will be tested and refined through completion of an iterative series of randomized trials that are interspersed with qualitative participant interviews. The purpose of each JITAI under investigation is to improve engagement with the Wysa for Chronic Pain app. |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement | The primary outcome for each JITAI is the between-group difference in engagement with Wysa for Chronic Pain during the JITAI's target engagement time interval. Engagement is operationalized as interaction(s) with the digital mental health intervention and is automatically captured throughout the study by the intervention's technical infrastructure. It is not self-reported. | Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) | The PHQ-ADS will be collected as the distal clinical outcome. It is a16-item self-reported measure that is used to assess depression and anxiety symptoms. Scores range from 0 to 48, and higher scores indicate more distress. | Baseline, Week 4, Week 8 (Not in pilot trial), Week 12 (Not in pilot trial) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriana Martin | Contact | 314-530-9023 | azmartin@wustl.edu | |
| Research Coordinator | Contact | 314-747-8489 |
| Name | Affiliation | Role |
|---|---|---|
| Abby L. Cheng, MD, MPHS | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40961490 | Derived | Cheng AL, Abraham J, Hartz SM, Laber EB, Miller JP. Evaluating and Optimizing Just-in-Time Adaptive Interventions in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain: Protocol for a Series of Randomized Trials. JMIR Res Protoc. 2025 Sep 17;14:e77532. doi: 10.2196/77532. |
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De-identified participant-level data will be shared through the NIMH Data Archive (NDA). Access to the dataset will be managed by the NDA.
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| Wysa for Chronic Pain | Behavioral | Wysa for Chronic Pain is an app-based digital mental health intervention that uses a behavioral activation framework and encourages users to work toward pain acceptance. The intervention also includes cognitive behavioral therapy, mindfulness, and sleep tools. |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
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