Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 29, 2024
Open Peer Review Period: Apr 2, 2024 - May 23, 2024
Date Accepted: Nov 4, 2024
(closed for review but you can still tweet)
Adaptive just-in-time intervention to reduce everyday stress responses: Protocol for a randomized controlled trial.
ABSTRACT
Background:
There is a growing demand for personalized approaches to behavior change to improve mental and physical health outcomes. Reducing the intensity, duration, and/or frequency of stress responses are one potential target mechanism for intervention that could lead to improvements in health behaviors and outcomes. Traditional approaches to stress measurement have generally not considered the dynamic and temporal nature of the stress experience that occurs within an individual as they navigate everyday life. We developed a measurement approach that can identify personalized stress responses in the moments and contexts in which they occur and propose that intervening on these stress responses as they arise (i.e., just-in-time; JIT) will result in positive impacts on health behaviors.
Objective:
Our primary aim is to use an experimental medicine approach to evaluate the impact of a smartphone-delivered JIT stress management intervention on the frequency and intensity of person-specific stress responses (i.e., stress reactivity, non-recovery, and pile-up). Our secondary aim is to evaluate the impact of the JIT intervention on the enactment of health behaviors in everyday life (physical activity and sleep). Our third aim is to explore whether changes in stress responses mediate the interventions’ effects on health behaviors.
Methods:
In a two-arm Phase II clinical trial, we will enroll 210 adults in either a JIT stress management intervention or an active control condition. For four weeks, participants will use a smartphone to complete eight brief daily surveys reporting on subjective stress, affect, perseverative cognition, subjective sleep, and physical activity behaviors. Wearable devices will also assess sleep and physical activity over this period. After a 1-week run-in period, participants will be randomized to JIT intervention or active control for two weeks. Participants in the JIT condition will receive very brief stress management activities when reporting greater than typical stress responses, whereas control participants will receive no personalized stress management. Participants enrolled in both conditions will engage in self-monitoring for the entire study period and have access to an online stress management education module. Self-report outcomes will be assessed again 1-month post-intervention.
Results:
We will utilize mixed effects models to evaluate differences in person-specific stress responses between the two study groups (i.e., intervention versus control group) and evaluate the potential cumulative effect of receiving multiple interventions over the two-week study duration or if potential benefits develop over the course of the intervention period. We will conduct parallel analyses evaluating whether the intervention is associated with improvement in health behavior enactment (i.e., sleep and physical activity).
Conclusions:
We anticipate this research will contribute to advancing stress measurement and understanding the mechanisms of health behavior change. More broadly, we anticipate that this research will provide a conceptual roadmap to advance JIT interventions aimed at improving stress management and health behaviors. Clinical Trial: NCT05502575
Citation
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.