Protocol development for a qualitative methodological study within a trial (Qual-SWAT): the KARMA-Dep-2 trial [version 2; peer review: 2 approved]

<div><strong>Background:</strong> 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.</div> <div><strong>Methods:</strong> A descriptive qualitative study design will be used. Data will be collected via one-to-one semi-structured interviews, conducted via Microsoft Teams. The interview data will be analysed using Braun and Clarke's Thematic Analysis approach. One-to-one interviews will be conducted with three participant groups ( <em>N</em> = 30): 1) host trial patient-participants ( <em>n</em> = 10); 2) potentially eligible host trial patient-participants who refused enrolment in the host trial ( <em>n</em> = 10); and 3) clinician- / researcher-participants who are associated with work on the host trial ( <em>n</em> = 10).</div> <div><strong>Ethics and dissemination:</strong> Ethical approval has been granted by St. Patrick's Mental Health Services Research Ethics Committee, Ireland (Ref: Protocol 09/20). When the study is completed, a report will be prepared and submitted to the Health Research Board (HRB). Findings will be shared with the host trial team and study participants, and submitted for publication.</div> <div><strong>Host trial registration:</strong> ClinicalTrials.gov ( <a href="http://clinicaltrials.gov/show/NCT04939649" target="_blank">NCT04939649</a>); EudraCT ( 2019-003109-92). Official title: Ketamine as an Adjunctive Therapy for Major Depression - A Randomised Controlled Trial: [KARMA-Dep (2)].</div><p></p>