Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Over 45 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Supportive Care
Masking: Single (Participant)

Arm Groups

Arm	Description	Assigned Intervention
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.	Other: 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. Behavioral: 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.
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.	Behavioral: 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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Washington University School of Medicine

Study Contact

Adriana Martin
314-530-9023
azmartin@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.