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ArticleJMIR research protocols2025

Evaluating and Optimizing Just-in-Time Adaptive Interventions in a Digital Mental Health Intervention (Wysa for Chronic Pain) for Middle-Aged and Older Adults With Chronic Pain: Protocol for a Series of Randomized Trials.

Abby L Cheng, Joanna Abraham, Sarah M Hartz, Eric B Laber, J Philip Miller

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06978166 (Evaluating and Optimizing Just-In-Time Adaptive Interventions), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06978166 narecruitingnot on this map

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

TypeinterventionalSponsorWashington University School of MedicineRan2025 to 2026Enrolled1,000ConditionsChronic Pain, Depression, AnxietyArmsJust-In-Time Adaptive Interventions (JITAIs), Wysa for Chronic Pain
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Abby L ChengDivision of Musculoskeletal Physical Medicine and Rehabilitation, Department of Orthopaedic Surgery, Washington University in St. Louis School of Medicine, St. Louis, MO, United States.ORCID 0000-0002-8166-0806
Joanna AbrahamDepartment of Anesthesiology & Institute for Informatics, Washington University in St. Louis School of Medicine, St. Louis, MO, United States.ORCID 0000-0002-3576-5279
Sarah M HartzDepartment of Psychiatry, Washington University in St. Louis School of Medicine, St. Louis, MO, United States.ORCID 0000-0002-5429-3799
Eric B LaberDepartment of Biostatistics and Bioinformatics, Duke University, Durham, United States.ORCID 0000-0003-2640-7696
J Philip MillerInstitute for Informatics, Data Science, and Biostatistics (I2DB), Washington University in St. Louis School of Medicine, St. Louis, MO, United States.ORCID 0000-0003-4568-6846

Funding

Digital mental health intervention for middle-aged and older adults with depression and/or anxiety and coexisting chronic painR01MH131989 · NIMH · WASHINGTON UNIVERSITY · PI Abby Ling-Lee Cheng · 2024 to 2026
$2.7M
Next-generation SMARTs for Discovery and Evaluation of Sequential Cancer Therapeutic StrategiesR01CA280970 · NCI · DUKE UNIVERSITY · PI Eric Benjamin Laber · 2024 to 2026
$1.1M
NCI NIH HHS R01 CA280970NIMH NIH HHS R01 MH131989
6 · The paper itself

Abstract

backgroundOn 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.

objectiveThe 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.

methodsUsing 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.

resultsInstitutional 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.

conclusionsCompletion 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 registrationClinicalTrials.gov NCT06978166; https://clinicaltrials.gov/study/NCT06978166. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/77532.

Indexed as

Chronic PainAgedAnxietyDepressionFemaleHumansMaleMental HealthMiddle AgedMobile ApplicationsRandomized Controlled Trials as TopicTelemedicineanxietychronic paindepressiondigital mental health interventionengagementhuman-centered designjust-in-time adaptive interventionmicrorandomized trialmiddle-aged adultsolder adults

Identifiers

PMID40961490
PMCPMC12489412

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.