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.
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)
Frequent active suicidal ideation
No access to a mobile device
Not living in the United States
Sequential
Just-In-Time Adaptive Interventions (JITAIs)
Other interventionJITAIs 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
BehavioralWysa 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.
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.
Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS)
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.
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Washington University School of Medicine
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Duke University
Collaborator
Wysa
Collaborator
