PROJECT SUMMARY / ABSTRACT
On a population level, digital mental health interventions effectively reduce depression and anxiety symptoms.
However, middle-aged and older adults with depression and/or anxiety and coexisting chronic pain have not
been adequately represented in digital mental health studies and are a significant population because: 1)
chronic pain reduces the effectiveness of stand-alone mental health treatment unless a person’s pain is
simultaneously addressed; 2) the prevalence of chronic pain increases with age; 3) physical and mental health
related disability in these age groups have unique downstream effects (lost workforce, effects on dependent
children, strain on caregiver availability); and 4) use of technology in these age groups is widespread and
growing, but these users have unique digital health needs and preferences. This proposal is a partnership
between Washington University and Wysa, an established mental health app company that delivers cognitive
behavioral therapy, mindfulness training, and sleep tools using chatbot technology and human coaches. Wysa
has developed an app specifically for people with mental illness and coexisting chronic pain (Wysa for Chronic
Pain (WCP)) which addresses depression and anxiety via the intermediate mechanisms of behavioral
activation, pain acceptance, and sleep quality. However, the app is not yet designed to meet the usability
needs of middle-aged and older adults with chronic pain. The goals of this proposal are to: 1) refine an
established digital mental health intervention (WCP) for middle-aged and older adults with depression and/or
anxiety and coexisting chronic pain, and 2) determine its effectiveness. The central hypothesis is that
incorporating just-in-time adaptive interventions (JITAIs) and other usability-related adaptations will improve
app engagement and, subsequently, depression and anxiety symptoms in this target population. Using a
human-centered design approach, the Behavioral Intervention Technology (BIT) model will be leveraged to link
established behavioral change theory with technology-related usability and engagement factors. Study
activities will follow the Discover, Design / Build, and Test (DDBT) framework. Aim 1 is to identify stakeholder-
informed contextual determinants of engagement with WCP by the target population. Members of the target
population with varying levels of technological literacy will participate in semi-structured interviews and usability
testing. Next, in a series of micro-randomized trials, adaptations designed to increase engagement with WCP
(e.g., JITAIs) will be created, tested, and iteratively refined (Aim 2). Finally, in a pragmatic randomized clinical
trial including 4,000 commercial Wysa users, the real-world effectiveness of the package of adaptations to
improve depression and anxiety symptoms within 12 weeks will be determined in a hybrid type 1 effectiveness-
implementation study (Aim 3). This proposal responds to PAR-22-154’s call to leverage an existing partnership
between WU and a theory-driven, well-established digital health platform (Wysa) to rapidly develop and test
JITAIs and their effect on digital engagement in people with clinically significant functional impairment.
