Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial.

ABSTRACT:

Background

Despite methodological improvements in clinical trial design and conduct more generally, methodological limitations persist in trials concerning mental health care. A qualitative Study Within A Trial (Qual-SWAT), embedded in the KARMA-Dep-2 host trial, will be undertaken to explore and gain an understanding of two methodological questions in randomised trials specific to mental health care: (1) what are the key barriers and enablers of participation in randomised trials in mental health; and (2) how can randomised trials become part of routine mental health care. These issues will be examined from patient-participant and clinician- / researcher-participant perspectives, in alignment with PRioRiTy research themes.

Methods

A descriptive qualitative study design will

SUBMITTER: McCaffrey J 

PROVIDER: S-EPMC10285324 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature