The final version of the study protocol (Version 1.0) has been adopted. This binds the study endpoints, the intervention manual and the statistical analysis plan.
What a protocol contains
The study protocol is the study’s rulebook. It describes who can take part, how the training proceeds, which effects are measured with which instruments, and how the data will ultimately be analysed. With the release of Version 1.0, these specifications are no longer work in progress but a binding basis for everyone involved at every site.
The manual includes the structured design of the Personality-Oriented Self-Regulation Training: eleven modules that build on one another, leading from basic values and needs, through working with emotions and impulses, to application in everyday life. Standardised materials ensure that participants at different clinics receive comparable content.
Why fixing the protocol matters
A binding protocol prevents procedures from shifting unnoticed during the study. All centres work to the same standard, and the later analysis follows a plan that was fixed before the analysis began. The finalised Version 1.0 is thus the reference against which the further conduct of the study and its publication can be measured.