Digital Mental Health Intervention for Chronic Pain

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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Abby L. Cheng, MD, MPHS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

I often think about suicide.

No access to a mobile device

Not living in the United States

Timeline

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

Treatment Details

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.

Participant Groups

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+