JMIR Res Protoc. 2025 Sep 17;14:e77532. doi: 10.2196/77532.
ABSTRACT
BACKGROUND: On a population level, digital mental health interventions effectively reduce depression and anxiety symptoms. However, middle-aged and older adults with chronic pain and coexisting depression or anxiety have not been adequately represented in digital mental health studies.
OBJECTIVE: The goal of this study is to refine an existing mobile, digital mental health intervention (Wysa for Chronic Pain) that addresses symptoms of depression, anxiety, and coexisting chronic pain for the unique challenges and technology use patterns of middle-aged and older adults.
METHODS: Using a mixed methods, human-centered design approach and a series of randomized trials, we will test and iteratively refine just-in-time adaptive interventions (JITAIs) that are designed to increase engagement with a digital mental health intervention. Participants will be aged 45 years or older, endorse at least moderately severe depression or anxiety symptoms (Patient Health Questionnaire-9 or Generalized Anxiety Disorder-7 score ≥10), and have coexisting chronic pain (ie, pain on most days or every day in the past 3 months), and live in the United States. In this open, web-based trial, participants will all receive Wysa for Chronic Pain (by Wysa), which uses a behavioral activation framework and encourages users to work toward pain acceptance. The fully automated intervention also includes cognitive behavioral therapy, mindfulness, and sleep tools, among others. In each trial, participants will be randomized during a maximum 12-week study period to receive versus not receive novel JITAIs that are intended to reduce navigation burden and improve usability (and subsequent engagement and clinical effectiveness). The JITAIs are being designed with iterative user feedback, guided by the Discover, Design/Build, and Test framework and the Behavioral Intervention Technology model. The proximal outcome for each JITAI is related to engagement with Wysa for Chronic Pain after JITAI delivery (compared to when no JITAI is delivered). The primary distal clinical outcome is the Patient Health Questionnaire Anxiety and Depression Scale. Based on statistical analysis that is triangulated with qualitative feedback from a subsample of trial participants, the JITAIs will be iteratively refined and retested in subsequent microrandomized trials until retesting of refined adaptations no longer yields meaningful improvement in immediate engagement or a maximum of 5 total trials have been completed.
RESULTS: Institutional review board approval was obtained on April 11, 2025. The first participant was enrolled on June 2, 2025, and recruitment is expected to conclude in 2026.
CONCLUSIONS: Completion of this project will result in iteratively refined JITAIs that are designed to improve usability and engagement with a digital mental health intervention by middle-aged and older adults with depression or anxiety and coexisting chronic pain.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06978166; https://clinicaltrials.gov/study/NCT06978166.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/77532.
PMID:40961490 | DOI:10.2196/77532
