Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial.
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Authors
McCaffrey, John
Masashi Terao
McCaffrey, Cathal
Igoe, Anna
Loughran, Orlaith
McDonagh, Kelly
McDonogh, Sarah
Shackleton, E
Whooley, Emma
Jelovac, Ana
Issue Date
2023-11-20
Type
Journal Article
Language
en
Keywords
mental health , qualitative , randomised trial , recruitment and retention , study within a trial (SWAT) , trial methodology
Alternative Title
Abstract
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.
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 ( = 30): 1) host trial patient-participants ( = 10); 2) potentially eligible host trial patient-participants who refused enrolment in the host trial ( = 10); and 3) clinician- / researcher-participants who are associated with work on the host trial ( = 10).
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.
ClinicalTrials.gov ( NCT04939649); EudraCT ( 2019-003109-92). Official title: Ketamine as an Adjunctive Therapy for Major Depression - A Randomised Controlled Trial: [KARMA-Dep (2)].
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 ( = 30): 1) host trial patient-participants ( = 10); 2) potentially eligible host trial patient-participants who refused enrolment in the host trial ( = 10); and 3) clinician- / researcher-participants who are associated with work on the host trial ( = 10).
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.
ClinicalTrials.gov ( NCT04939649); EudraCT ( 2019-003109-92). Official title: Ketamine as an Adjunctive Therapy for Major Depression - A Randomised Controlled Trial: [KARMA-Dep (2)].
Description
Citation
McCaffrey, J., & Hunter, A. (2023). Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial. HRB open research, 6, 29. https://doi.org/10.12688/hrbopenres.13721.1
Publisher
License
Copyright: © 2023 McCaffrey J and Hunter A.
Journal
HRB open research
Volume
6
Issue
PubMed ID
DOI
10.12688/hrbopenres.13721.1
10.1177/26320843221080734
10.2196/24055
10.1177/26320843221106949
10.1177/26320843221106961
10.1191/1478088706qp063oa
10.1186/s13063-019-3687-7
10.1016/S2215-0366(22)00041-4
10.1016/S2215-0366(20)30191-7
10.1177/26320843221089632
10.1007/s11845-019-01980-2
10.1002/aet2.10644
10.1002/wps.21056
10.1002/wps.20661
10.1002/wps.21069
10.1080/13645579.2020.1803528
10.1017/S0033291722001362
10.1177/26320843221147841
10.1016/j.apnu.2008.10.008
10.1186/s12913-018-2915-2
10.1038/s44159-022-00050-2
10.12688/hrbopenres.13182.2
10.1186/s13063-019-3704-x
10.1080/01612840.2018.1475524
10.1186/s13063-018-2544-4
10.1186/s13063-018-2964-1
10.1016/j.socscimed.2021.114523
10.1136/jech.51.4.354
10.1002/14651858.MR000045.pub2
10.1038/s41380-021-01200-3
10.1177/13607804211003579
10.1016/j.jbtep.2022.101744
10.1007/s00787-021-01839-x
10.1371/journal.pone.0203127
10.1111/hex.13650
10.1177/09526951211009085
10.1177/1363459318785720
10.1007/s11845-020-02330-3
10.1007/s11136-022-03122-1
10.1007/s40501-020-00217-9
10.1177/1609406917733847
10.1097/ACM.0000000000000388
10.1016/j.cpr.2021.102111
10.1108/QRJ-06-2022-0086
10.1136/ebnurs-2021-103501
10.1186/s13063-022-06308-7
10.1186/s40900-020-00239-w
10.1038/s41380-021-01381-x
10.1017/S0033291712001663
10.1038/s41746-022-00581-1
10.1186/s12874-022-01553-5
10.1080/13645579.2023.2183007
10.1186/s13063-018-2535-5
10.1007/s00787-020-01710-5
10.1177/16094069221110317
10.1001/jama.2013.281053
10.1007/s40299-021-00619-0
10.1186/s12913-022-08887-2
10.1136/bmj.h809
10.1177/26320843221080734
10.2196/24055
10.1177/26320843221106949
10.1177/26320843221106961
10.1191/1478088706qp063oa
10.1186/s13063-019-3687-7
10.1016/S2215-0366(22)00041-4
10.1016/S2215-0366(20)30191-7
10.1177/26320843221089632
10.1007/s11845-019-01980-2
10.1002/aet2.10644
10.1002/wps.21056
10.1002/wps.20661
10.1002/wps.21069
10.1080/13645579.2020.1803528
10.1017/S0033291722001362
10.1177/26320843221147841
10.1016/j.apnu.2008.10.008
10.1186/s12913-018-2915-2
10.1038/s44159-022-00050-2
10.12688/hrbopenres.13182.2
10.1186/s13063-019-3704-x
10.1080/01612840.2018.1475524
10.1186/s13063-018-2544-4
10.1186/s13063-018-2964-1
10.1016/j.socscimed.2021.114523
10.1136/jech.51.4.354
10.1002/14651858.MR000045.pub2
10.1038/s41380-021-01200-3
10.1177/13607804211003579
10.1016/j.jbtep.2022.101744
10.1007/s00787-021-01839-x
10.1371/journal.pone.0203127
10.1111/hex.13650
10.1177/09526951211009085
10.1177/1363459318785720
10.1007/s11845-020-02330-3
10.1007/s11136-022-03122-1
10.1007/s40501-020-00217-9
10.1177/1609406917733847
10.1097/ACM.0000000000000388
10.1016/j.cpr.2021.102111
10.1108/QRJ-06-2022-0086
10.1136/ebnurs-2021-103501
10.1186/s13063-022-06308-7
10.1186/s40900-020-00239-w
10.1038/s41380-021-01381-x
10.1017/S0033291712001663
10.1038/s41746-022-00581-1
10.1186/s12874-022-01553-5
10.1080/13645579.2023.2183007
10.1186/s13063-018-2535-5
10.1007/s00787-020-01710-5
10.1177/16094069221110317
10.1001/jama.2013.281053
10.1007/s40299-021-00619-0
10.1186/s12913-022-08887-2
10.1136/bmj.h809
ISSN
2515-4826