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Study Protocol Submitted to Trials

Publication

The PSRT study protocol has been submitted as a manuscript to the journal Trials (BMC/Springer Nature). The planned publication makes the methodological foundation of the intervention and the study design fully and permanently traceable.

Why a protocol is published

Publishing a study protocol before the results are available is good practice in clinical research. It discloses the research question, methodology and analysis plan before any data exist — thereby committing the study publicly to its own specifications. Trials is an open-access journal specialised in exactly such protocols and methods papers; the submission now undergoes scientific peer review by independent expert reviewers.

In terms of content, the manuscript describes the Personality-Oriented Self-Regulation Training and the theoretical framework from which it is derived, as well as the multicentre, controlled study design, the endpoints and the statistical analysis plan.

What this means for the project

With the submission, the work of recent years is presented to the professional public for scrutiny for the first time. If the journal accepts the protocol, it creates a citable reference point on which the later results publications can build. For the PSRT study, the submission is thus a visible transition from internal preparation to scientific discussion.