Just-In-Time Adaptive Interventions (JITAIs) in a Digital Mental Health Intervention for Middle-Aged and Older Adults With Chronic Pain

NCT06978166 | Recruiting DMC

• 2 other identifiers: Pro00085039R01MH131989
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Each JITAI has a different target engagement time interval. e.g., varying from 24 hours to 7 days.

Other Outcomes (1)

• Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)

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

Study Arms (2)

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.

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.

Behavioral: Wysa for Chronic Pain

Interventions

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 + JITAIs

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.

Wysa for Chronic Pain + JITAIs; Wysa for Chronic Pain without JITAIs

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Duke University: collaborator
• Wysa: collaborator
• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40961490 DERIVED

MeSH Terms

Conditions

Chronic Pain; Depression; Anxiety Disorders; Alzheimer Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Abby L. Cheng, MD, MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Martin

CONTACT

314-530-9023; azmartin@wustl.edu

Research Coordinator

CONTACT

314-747-8489

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 18, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)