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NCT Number: NCT06978166

Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention 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.

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Key information

Conditions

Chronic Pain Alzheimer Disease Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Depression, Anxiety Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Other outcomes

  1. Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)

    Time frame: Baseline, Week 4, Week 8 (Not in pilot trial), Week 12 (Not in pilot trial)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Martin

CONTACT

[email protected]

314-530-9023

Research Coordinator

CONTACT

314-747-8489

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Duke University
  • National Institute of Mental Health (NIMH)
  • Wysa

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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