Chronic PainNCT06978166
Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain
A study testing Just-In-Time Adaptive Interventions (JITAIs) and Wysa for Chronic Pain in people with Chronic Pain and Depression, Anxiety, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Pain, Depression, Anxiety
- What is being tested?
- Just-In-Time Adaptive Interventions (JITAIs) and Wysa for Chronic Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 773 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 29 Oct 2026
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years or older
- At least moderately severe depression and/or anxiety symptoms (Patient Health Questionnaire-9 (PHQ-9) and/or Generalized Anxiety Disorder-7 (GAD-7) score ≥ 10)
- Chronic pain (i.e., pain on most days or every day in the past three months)
Who cannot join
- Frequent active suicidal ideation
- No access to a mobile device
- Not living in the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluating and Optimizing Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain
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.
- Conditions
- Chronic Pain, Depression, Anxiety
- Being tested
- Just-In-Time Adaptive Interventions (JITAIs), Wysa for Chronic Pain
- Keywords
- JITAI, Digital mental health intervention, Older adults, Middle-aged adults, App, Smartphone, Chronic pain, Depression, Anxiety, Chatbot
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Wysa for Chronic PainBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Just-In-Time Adaptive Interventions (JITAIs); Behavioral: Wysa for Chronic Pain |
| 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. Receives: Behavioral: Wysa for Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start2 Jun 2025
- Primary completion29 Oct 2026
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Washington University School of MedicineThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Duke University, Wysa
- Responsible party
- Principal investigator, Abby Cheng, Washington University School of Medicine
- Investigators
- Abby L. Cheng, MD, MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978166
- Sponsor's protocol ID
- Pro00085039
- Other IDs
- R01MH131989
- Status last verified
- Nov 2026
- First submitted
- 5 May 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data will be shared through the NIMH Data Archive (NDA). Access to the dataset will be managed by the NDA.
Publications
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.
PubMed 40961490
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating and Optimizing Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain
- ClinicalTrials.gov ID
- NCT06978166
- Acronym / sponsor ID
- Pro00085039
- Conditions
- Chronic Pain, Depression, Anxiety
- Keywords
- JITAI, Digital mental health intervention, Older adults, Middle-aged adults, App, Smartphone, Chronic pain, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Duke University, Wysa
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 29 Oct 2026 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 18 May 2025 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wysa for Chronic Pain + JITAIs | Experimental | Other: Just-In-Time Adaptive Interventions (JITAIs), Behavioral: Wysa for Chronic PainParticipants 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. |
| Wysa for Chronic Pain without JITAIs | Active comparator | Behavioral: Wysa for Chronic PainParticipants 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 45 years or older
- At least moderately severe depression and/or anxiety symptoms (Patient Health Questionnaire-9 (PHQ-9) and/or Generalized Anxiety Disorder-7 (GAD-7) score ≥ 10)
- Chronic pain (i.e., pain on most days or every day in the past three months)
Key exclusion criteria (3 listed)
- Frequent active suicidal ideation
- No access to a mobile device
- Not living in the United States
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 |
|---|---|---|
| Just-In-Time Adaptive Interventions (JITAIs)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. | Other | Wysa for Chronic Pain + JITAIs |
| Wysa for Chronic PainWysa 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. | Behavioural | Wysa for Chronic Pain + JITAIs, Wysa for Chronic Pain without JITAIs |
Primary outcome
Engagement
Time frame: Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days.
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.
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 6 Nov 2026.
- Derived from this study: PubMed 40961490Cheng 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.
- Individual participant dataSharing planned: Yes. 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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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.
Abby L. Cheng, MD, MPHS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Just-In-Time Adaptive Interventions (JITAIs) and Wysa for Chronic Pain in people with Chronic Pain and Depression, Anxiety, run by Washington University School of Medicine 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 3 inclusion and 3 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 6 Nov 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.
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?
Engagement (time frame: Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days.). 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 NCT06978166, which also lists 1 linked publication.
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 6 Nov 2026.