Recruiting

Wysa for Chronic Pain

Sponsor:

Washington University School of Medicine

Code:

NCT06978166

Conditions

Chronic Pain

Depression, Anxiety

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Just-In-Time Adaptive Interventions (JITAIs)

Wysa for Chronic Pain

Study Details

Brief 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. 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

Study ID

NCT06978166

Start date

Jun 2, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Frequent active suicidal ideation
  • No access to a mobile device
  • Not living in the United States

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Wysa for Chronic Pain + JITAIs

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.

active comparator: Wysa for Chronic Pain without JITAIs

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.

Interventions

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.

Wysa for Chronic Pain

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.

Primary outcome measure

  • Engagement [ Time Frame: Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days. ]

Central Contacts and Locations

Central contacts

Adriana Martin

314-530-9023azmartin@wustl.edu

Research Coordinator

314-747-8489

Locations

Washington University in St. Louis School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

More Information

Sponsor

Washington University School of Medicine

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • JITAI
  • Digital mental health intervention
  • Older adults
  • Middle-aged adults
  • App
  • Smartphone
  • Chronic pain
  • Depression
  • Anxiety
  • Chatbot

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-05-05.