Digital Mental Health Intervention for Chronic Pain

Recruiting at 1 trial location

Overseen By Adriana Martin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Suicidal ideation, No mobile device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Wysa for Chronic Pain, designed to assist people with chronic pain who also experience depression or anxiety. The study aims to determine how customized notifications, known as Just-In-Time Adaptive Interventions (JITAIs), can enhance users' experiences with the app. Participants will use the app over several weeks and answer surveys about their mood, pain, and sleep. Individuals who have experienced chronic pain most days over the past three months and have moderate depression or anxiety symptoms might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve support for chronic pain management.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the study focuses on using a mobile app for chronic pain and mental health support.

What prior data suggests that this digital mental health intervention is safe for chronic pain patients?

Research has shown that Just-In-Time Adaptive Interventions (JITAIs) are well-received in various studies. These interventions provide support precisely when needed. Studies indicate they are generally safe and accepted by users. For instance, a review found that JITAIs are practical and appreciated for their timely support.

Although specific safety data for JITAIs is not available in the provided sources, their use in mobile health has been studied. The results suggest these interventions do not cause harm and aim to enhance user engagement and experience.

Overall, despite limited direct safety data, previous research supports that JITAIs are usually well-tolerated. They have been used in other health apps without major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Mental Health Intervention for Chronic Pain because it introduces Just-In-Time Adaptive Interventions (JITAIs) within the Wysa for Chronic Pain app. Unlike traditional therapies for chronic pain, which often involve medication or regular therapy sessions, JITAIs offer personalized, real-time support by delivering interventions precisely when a user needs them, based on specific trigger criteria. This novel approach allows for a more flexible and responsive treatment experience, potentially improving pain management by adapting to individual needs in the moment. This level of customization and immediacy is what makes this treatment stand out from current options.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that Just-In-Time Adaptive Interventions (JITAIs) can reduce symptoms of depression and anxiety, often linked to chronic pain. Studies have found that digital mental health tools like these can have lasting positive effects, even months after use. JITAIs offer personalized support exactly when needed, based on individual needs or situations. This method has successfully improved mental health by keeping users engaged and providing timely assistance. In this trial, participants in one arm will receive the Wysa for Chronic Pain app with the novel JITAIs incorporated, while those in the other arm will use the app without JITAIs. Although this version of the Wysa app is new, the JITAIs approach has a strong track record in similar situations. ^{1 2 4 6 7}

Who Is on the Research Team?

Abby L. Cheng, MD, MPHS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for middle-aged and older adults who suffer from chronic pain accompanied by symptoms of depression or anxiety. Participants will use a mobile app called Wysa for Chronic Pain, which isn't yet public, to help manage their condition.

Inclusion Criteria

I have moderate to severe depression or anxiety.

I am 45 years old or older.

I have experienced pain almost daily for the past three months.

Exclusion Criteria

No access to a mobile device

Not living in the United States

I often think about suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Treatment

Participants use the Wysa for Chronic Pain app with JITAIs for 4 weeks

4 weeks

Main Treatment

Participants use the Wysa for Chronic Pain app with or without JITAIs for 12 weeks

12 weeks

Follow-up

Participants complete surveys and optional interviews to assess mood, pain, and app experience

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Just-In-Time Adaptive Interventions (JITAIs)

Trial Overview The study tests customized notifications within the Wysa app to improve user experience. Participants will engage with the app over several weeks, completing surveys on mood, pain, function, and sleep at the start and end.

How Is the Trial Designed?

Group I: Wysa for Chronic Pain + JITAIs Experimental Treatment 2 Interventions

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.

Group II: Wysa for Chronic Pain without JITAIs Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Wysa

Industry Sponsor

Trials

3

Recruited

730+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12489412/

Evaluating and Optimizing Just-in-Time Adaptive Interventions ... On a population level, digital mental health interventions effectively reduce depression and anxiety symptoms. However, middle-aged and older adults with ...

2. mentalhealth.bmj.com mentalhealth.bmj.com/content/28/1/e301641

Effectiveness of just-in-time adaptive interventions for ... Nine studies reported follow-up effects (mean follow-up time M=3.06 months, SD=2.21) with significant results at 1 and 3–6 months. Interventions ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06978166

NCT06978166 | Just-In-Time Adaptive Interventions (JITAIs ... 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.

4. researchprotocols.org researchprotocols.org/2025/1/e58917

Just-In-Time Adaptive Interventions to Promote Behavioral ... This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5364076/

Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health A JITAI includes 6 key elements: a distal outcome, proximal outcomes, decision points, intervention options, tailoring variables, and decision rules. State of ...

6. researchprotocols.org researchprotocols.org/2025/1/e77532

Protocol for a Series of Randomized Trials The main purpose of the initial 4-week pilot trial is to determine the initial randomization probability for each JITAI in the first MRT for the ...

7. jahonline.org jahonline.org/article/S1054-139X(25)00367-2/fulltext

Just-in-Time Adaptive Interventions for Adolescent and ... This systematic review examines the characteristics, feasibility, acceptability, and efficacy of just-in-time adaptive interventions ...