Tutorial: The practical application of longitudinal structural equation mediation models in clinical trials

Goldsmith, Kimberley A.; MacKinnon, David P.; Chalder, Trudie; White, Peter D.; Sharpe, Michael; Pickles, Andrew

doi:10.1037/met0000154

Cited by 99Advanced Causal Inference TechniquesStatistical Methods and Bayesian InferencePsychometric Methodologies and Testing

Tutorial: The practical application of longitudinal structural equation mediation models in clinical trials

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Goldsmith, Kimberley A., MacKinnon, David P., Chalder, Trudie, White, Peter D., Sharpe, Michael, Pickles, Andrew·2018·Psychological Methods

DOI 10.1037/met0000154PMC PMC5975099

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Abstract

The study of mediation of treatment effects, or how treatments work, is important to understanding and improving psychological and behavioral treatments, but applications often focus on mediators and outcomes measured at a single time point. Such cross-sectional analyses do not respect the implied temporal ordering that mediation suggests. Clinical trials of treatments often provide repeated measures of outcomes and, increasingly, of mediators as well. Repeated measurements allow the application of various types of longitudinal structural equation mediation models. These provide flexibility in modeling, including the ability to incorporate some types of measurement error and unmeasured confounding that can strengthen the robustness of findings. The usual approach is to identify the most theoretically plausible model and apply that model. In the absence of clear theory, we put forward the option of fitting a few theoretically plausible models, providing a type of sensitivity analysis for the mediation hypothesis. In this tutorial, we outline how to fit several longitudinal mediation models, including simplex, latent growth and latent change models. This will allow readers to learn about one type of model that is of interest, or about several alternative models, so that they can take this sensitivity approach. We use the Pacing, Graded Activity, and Cognitive Behavioral Therapy: A Randomized Evaluation (PACE) trial of rehabilitative treatments for chronic fatigue syndrome (ISRCTN 54285094) as a motivating example and describe how to fit and interpret various longitudinal mediation models using simulated data similar to those in the PACE trial. The simulated data set and Mplus code and output are provided. (PsycINFO Database Record

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An advantage of models that capture longitudinal change on two or more variables simultaneously across a smaller number of time points is that they can be applied in contexts where intensive longitudinal data collection is not practical, while still offering insight into timing and direction of process-outcome relationships.
“In addition to requiring fewer time points, an advantage of these latter models is that they can be applied in contexts in which it is not practical to adopt intensive longitudinal data collection, while still offering insight into the timing and direction of process-outcome relationships.”
From Acceptance and Commitment Therapy Processes and Mediation: Challenges and How to Address Them (2023) · cites this paper as Goldsmith et al., 2018

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The mediation role of emotion regulation strategies on the relationship between mindfulness effects, psychological well-being and distress among youths: Findings from a randomized controlled trial
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Examining the role of living alone and loneliness in predicting health-related quality of life: results from the Healthy Aging Longitudinal Study in Taiwan (HALST)
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The effect of an adapted Mindfulness-Based Stress Reduction program on mental health, maternal bonding and birth outcomes in psychosocially vulnerable pregnant women: a study protocol for a randomized controlled trial in a Danish hospital-based outpatient setting
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In search of convergent creativity: content analysis of research on intellectual humility
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Multiple imputation of missing data in multilevel ecological momentary assessments: an example using smoking cessation study data
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The Effect of Neuroepo on Cognition in Parkinson’s Disease Patients Is Mediated by Electroencephalogram Source Activity
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Is it bad because it is boring? Effects of idle time on employee outcomes
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A randomized trial of adapted versus standard versions of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction implemented via facilitation and delivered by community mental health providers: improving the “fit” of psychological treatments by adapting to context
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Commentary: Mediation and Moderation: An Historical Progress Report
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The Power to Flirt: Power within Romantic Relationships and Its Contribution to Expressions of Extradyadic Desire
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Mediators for the Effect of Compassion Cultivating Training: A Longitudinal Path Analysis in a Randomized Controlled Trial Among Caregivers of People With Mental Illness
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Mindful non-reactivity and psychological flexibility mediate the effect of internet-delivered acceptance and commitment therapy for health anxiety
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Causal Mediation Analysis with the Parallel Process Latent Growth Curve Mediation Model
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COVID-19-related stressful experiences and posttraumatic stress disorder symptoms among college students in China: A moderated mediation model of perceived control over the future and empathy
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Altered self-reported resting state mediates the effects of Mindfulness-Based Stress Reduction on mental health: a longitudinal path model analysis within a community-based randomized trial with 6-months follow-up
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Subgroup Analysis: “What Works Best for Whom and Why?”
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Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial
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The Effectiveness of Compassionate Mind Training (CMT) for Undergraduate Students
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The Impact of Monetary Incentives on Delay Discounting Within a Year-Long Physical Activity Intervention
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Perseverative thinking, threat interpretation bias, and emotional reactivity as mediators between adverse childhood experience domains and psychopathology: A longitudinal mediation study in a cohort of Swiss emerging adults
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Using SymPy (Symbolic Python) for Understanding Structural Equation Modeling
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Causal Inference: Efficacy and Mechanism Evaluation
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How and for whom does supportive adjustment to multiple sclerosis cognitive-behavioural therapy work? A mediated moderation analysis
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Protocol for a multisite, parallel-group, randomized clinical trial comparing a brief tele-cognitive behavioral therapy intervention (BRIGHT) with attention control for the reduction of body image-related distress among head and neck cancer survivors
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Determining the Impact of a Physiotherapist-Led Primary Care Model for Low Back Pain: Protocol and Analysis Plan for a Cluster Randomized Controlled Trial and Embedded Process Evaluation
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Toward a mechanistic understanding of LGBTQ-affirmative cognitive-behavioral therapy: Testing treatment mediators in a randomized controlled trial with young gay and bisexual men
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From technology to transformation: How AI governance initiatives drives sustainability through managerial and organizational mediation
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Is patient activation a mediator of the effect of a health promoting intervention in adults at high risk of type 2 diabetes? A longitudinal path model analysis within a randomised trial
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Living Alone and Loneliness in Predicting Health-Related Quality of Life: Results from the Healthy Aging Longitudinal Study in Taiwan (HALST)Preprint
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Temporal Associations Between Depression and Hostility in the Context of a Divorce Intervention
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Conceptualizing and Examining Dynamics in Communication ResearchPreprint
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Causal Inference: Efficacy and Mechanism Evaluation
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Treating Pediatric Insomnia in young children: A RCT of a group-based, parent-focused behavioural sleep interventionPreprint
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Examining Consistency in Intervention Response With Multiple-Groups Latent Curve Models: A TutorialPreprint
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Social Acknowledgment, Individual Posttraumatic Cognitions, Posttraumatic Stress Disorder, and their associations following Trauma Exposure
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Social Acknowledgment, Individual Posttraumatic Cognitions, Posttraumatic Stress Disorder, and their associations following Trauma Exposure
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THE STATE OF THE ART ON STRUCTURAL EQUATION MODELING
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Additional file 1 of A randomized controlled trial of a preventive intervention for the children of parents with depression: mid-term effects, mediators and moderators
Löchner, J., Platt, B., Starman‐Wöhrle, K., Takano, K., Engelmann, L., Voggt, A., Loy, F., Bley, M., Winogradow, D., Hämmerle, S., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26598785
Additional file 1 of Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial
Wolf, S., Seiffer, B., Zeibig, J.-M., Welkerling, J., Bauer, L. L., Frei, A. K., Studnitz, T., Rosenstiel, S., Fiedler, D. V., Helmhold, F., et al. (2021) · Figshare · doi:10.6084/m9.figshare.16909996
Longitudinal relationships among dissociation, paranoia, and anxiety in a clinical sample of individuals with schizophrenia-spectrum conditions
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Addiction at the Bottom of the Ladder: Subjective Socioeconomic Status and Adolescent Smartphone Addiction from a Self-Determination Theory Perspective
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Processes of change in cognitive-behavioral psychotherapy for procrastination: moderation and longitudinal mediation analyses of randomized controlled trial data
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Efficacy of blended digital and face-to-face psychotherapy compared to enhanced psychotherapy for patients with Somatic Symptom Disorder (iSOMA+): study protocol for a multicenter randomized controlled pragmatic trial
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Testing Mediational Models With Longitudinal Data: Questions and Tips in the Use of Structural Equation Modeling.
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Instrumental variable and longitudinal structural equation modelling methods for causal mediation : the PACE trial of treatments for chronic fatigue syndrome
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Self-citation

Authors: Goldsmith, K. A., MacKinnon, D. P., Chalder, T., White, P. D., Sharpe, M., & Pickles, A.
Affiliations: King's College London (GB)
Arizona State University (US)
Queen Mary University of London (GB)
University of Oxford (GB)
ORCID: Goldsmith, Kimberley A.
MacKinnon, David P.
Chalder, Trudie
White, Peter D.
Sharpe, Michael
Pickles, Andrew
Venue: Psychological Methods
Publisher: American Psychological Association (APA)
Published: 2018-06
Volume: 23
Issue: 2
Pages: 191-207
ISSN: 1082-989X (ISSN-L)
1939-1463
DOI: 10.1037/met0000154
PMC: PMC5975099
OpenAlex: W2613335938
Cited by: 99
References: 88
Citations by year: 2026: 14 · 2025: 9 · 2024: 15 · 2023: 17 · 2022: 17 · 2021: 15 · 2020: 6 · 2019: 5 · 2018: 1
FWCI: 2.28
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: other-oa
www.apa.org/pubs/journals/resources/open-access.aspx (vor)
Locations: Psychological Methods (publishedVersion, other-oa)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Research Portal (King's College London) (submittedVersion, other-oa)
Funders: Medical Research Council
Department for Health for England
The Scottish Chief Scientist Office
Department for Work and Pensions
National Institute for Health Research (DRF-2011-04-061)
King’s College London
National Institute on Drug Abuse (DA09757)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
Keywords: mediation analysis, clinical trials, repeated measures, latent growth curve models, latent change score models, sensitivity analysis, measurement error, unmeasured confounding, chronic fatigue syndrome, PACE trial
MeSH terms: Clinical Trials as Topic, Humans, Research Design, Models, Statistical, Fatigue Syndrome, Chronic, Outcome Assessment, Health Care

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