Demonstration of a "leapfrog" randomized controlled trial as a method to accelerate the development and optimization of psychological interventions

  • \(\bf Background\) The scale of the global mental health burden indicates the inadequacy not only of current treatment options, but also the pace of the standard treatment development process. The "leapfrog" trial design is a newly-developed simple Bayesian adaptive trial design with potential to accelerate treatment development. A first leapfrog trial was conducted to provide a demonstration and test feasibility, applying the method to a low-intensity internet-delivered intervention targeting anhedonia. \(\bf Methods\) At the start of this online, single-blind leapfrog trial, participants self-reporting depression were randomized to an initial control arm comprising four weeks of weekly questionnaires, or one of two versions of a four-week cognitive training intervention, imagery cognitive bias modification (imagery CBM). Intervention arms were compared to control on an ongoing basis via sequential Bayesian analyses, based on a primary outcome of anhedonia at post-intervention. Results were used to eliminate and replace arms, or to promote them to become the control condition based on pre-specified Bayes factor and sample size thresholds. Two further intervention arms (variants of imagery CBM) were added into the trial as it progressed. \(\bf Results\) \(\it N\) = 188 participants were randomized across the five trial arms. The leapfrog methodology was successfully implemented to identify a "winning" version of the imagery CBM, i.e. the version most successful in reducing anhedonia, following sequential elimination of the other arms. \(\bf Conclusions\) The study demonstrates feasibility of the leapfrog design and provides a foundation for its adoption as a method to accelerate treatment development in mental health. Registration:, NCT04791137.

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Author:Simon E. BlackwellORCiDGND, Felix D. SchönbrodtORCiDGND, Marcella WoudORCiDGND, André WannemüllerGND, Büsra BektasGND, Max Braun RodriguesGND, Josefine HirdesGND, Michael StumppORCiDGND, Jürgen MargrafORCiDGND
Parent Title (English):Psychological medicine
Publisher:Cambridge University Press
Place of publication:Cambridge
Document Type:Article
Date of Publication (online):2023/01/19
Date of first Publication:2022/11/04
Publishing Institution:Ruhr-Universität Bochum, Universitätsbibliothek
Tag:Adaptive trial; Bayes factor; clinical translation; leapfrog; sequential Bayesian analysis
First Page:6113
Last Page:6123
Institutes/Facilities:Forschungs- und Behandlungszentrum für psychische Gesundheit
Dewey Decimal Classification:Philosophie und Psychologie / Psychologie
open_access (DINI-Set):open_access
faculties:Fakultät für Psychologie
Licence (English):License LogoCreative Commons - CC BY 4.0 - Attribution 4.0 International