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

The Washington University

Status: Not yet enrolling

Conditions: Depression, Anxiety; Chronic Pain

Treatments: Behavioral: Wysa for Chronic Pain; Other: Just-In-Time Adaptive Interventions (JITAIs)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06978166

Pro00085039

R01MH131989 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Wysa for Chronic Pain + JITAIs

Experimental group

Description:

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.

Treatment:

Behavioral: Wysa for Chronic Pain

Other: Just-In-Time Adaptive Interventions (JITAIs)

Wysa for Chronic Pain without JITAIs

Active Comparator group

Description:

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.

Treatment:

Behavioral: Wysa for Chronic Pain