A Causal Approach to Functional Mediation Analysis with Application to a Smoking Cessation Intervention

Abstract

The increase in the use of mobile and wearable devices now allows dense assessment of mediating processes over time. For example, a pharmacological intervention may have an effect on smoking cessation via reductions in momentary withdrawal symptoms. We define and identify the causal direct and indirect effects in terms of potential outcomes on the mean difference and odds ratio scales, and present a method for estimating and testing the indirect effect of a randomized treatment on a distal binary variable as mediated by the nonparametric trajectory of an intensively measured longitudinal variable (e.g., from ecological momentary assessment). Coverage of a bootstrap test for the indirect effect is demonstrated via simulation. An empirical example is presented based on estimating later smoking abstinence from patterns of craving during smoking cessation treatment. We provide an R package, funmediation, available on CRAN at https://cran.r-project.org/web/packages/funmediation/index.html, to conveniently apply this technique. We conclude by discussing possible extensions to multiple mediators and directions for future research.

Keywords:

• Ecological momentary assessment
• functional regression
• indirect effect
• mediation
• smoking
• time-varying effect modeling

Article information

Conflict of Interest Disclosures: Each author signed a form for disclosure of potential conflicts of interest. No authors reported any financial or other conflicts of interest in relation to the work described.

Ethical Principles: The authors affirm having followed professional ethical guidelines in preparing this work. These guidelines include obtaining informed consent from human participants, maintaining ethical treatment and respect for the rights of human or animal participants, and ensuring the privacy of participants and their data, such as ensuring that individual participants cannot be identified in reported results or from publicly available original or archival data.

Funding: This work was supported by grants 1R01 CA229542-01 from the National Cancer Institute and the National Institutes of Health Office of Behavioral and Social Science Research, 5R01HL109031 from the National Heart, Lung, and Blood Institute, and P50 DA039838 from the National Institute on Drug Abuse.

Role of the Funders/Sponsors: None of the funders or sponsors of this research had any role in the design and conduct of the study; collection, management, analysis, and interpretation of data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Acknowledgments: The ideas and opinions expressed herein are those of the authors alone, and endorsement by the authors’ institutions or the National Institutes of Health is not intended and should not be inferred.