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

Overview

Journal HRB Open Res

Specialty Biomedical Engineering

Date 2023 Jun 26

PMID 37361338

Authors

John McCaffrey

Andrew Hunter

Affiliations

Soon will be listed here.

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 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).

Ethics And Dissemination: 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.

Host Trial Registration: ClinicalTrials.gov ( NCT04939649); EudraCT ( 2019-003109-92). Official title: Ketamine as an Adjunctive Therapy for Major Depression - A Randomised Controlled Trial: [KARMA-Dep (2)].

References

Krause K, Edbrooke-Childs J, Bear H, Calderon A, Wolpert M . What treatment outcomes matter most? A Q-study of outcome priority profiles among youth with lived experience of depression. Eur Child Adolesc Psychiatry. 2021; 32(1):123-137. PMC: 9908724. DOI: 10.1007/s00787-021-01839-x. View

Newmark J, Gebara M, Aizenstein H, Karp J . Engaging in Late-Life Mental Health Research: a Narrative Review of Challenges to Participation. Curr Treat Options Psychiatry. 2020; 7(3):317-336. PMC: 7242610. DOI: 10.1007/s40501-020-00217-9. View

Hennink M, Kaiser B . Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2021; 292:114523. DOI: 10.1016/j.socscimed.2021.114523. View

Houghton C, Dowling M, Meskell P, Hunter A, Gardner H, Conway A . Factors that impact on recruitment to randomised trials in health care: a qualitative evidence synthesis. Cochrane Database Syst Rev. 2020; 10:MR000045. PMC: 8078544. DOI: 10.1002/14651858.MR000045.pub2. View

Howes O, Thase M, Pillinger T . Treatment resistance in psychiatry: state of the art and new directions. Mol Psychiatry. 2021; 27(1):58-72. PMC: 8960394. DOI: 10.1038/s41380-021-01200-3. View

Ormel J, Hollon S, Kessler R, Cuijpers P, Monroe S . More treatment but no less depression: The treatment-prevalence paradox. Clin Psychol Rev. 2021; 91:102111. DOI: 10.1016/j.cpr.2021.102111. View

. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013; 310(20):2191-4. DOI: 10.1001/jama.2013.281053. View

Chevance A, Ravaud P, Cornelius V, Mayo-Wilson E, Furukawa T . Designing clinically useful psychopharmacological trials: challenges and ways forward. Lancet Psychiatry. 2022; 9(7):584-594. DOI: 10.1016/S2215-0366(22)00041-4. View

Draucker C, Martsolf D, Poole C . Developing distress protocols for research on sensitive topics. Arch Psychiatr Nurs. 2009; 23(5):343-50. DOI: 10.1016/j.apnu.2008.10.008. View

10.

Tan R, Wu D, Day S, Zhao Y, Larson H, Sylvia S . Digital approaches to enhancing community engagement in clinical trials. NPJ Digit Med. 2022; 5(1):37. PMC: 8956701. DOI: 10.1038/s41746-022-00581-1. View

11.

Liu Y, Pencheon E, Hunter R, Moncrieff J, Freemantle N . Recruitment and retention strategies in mental health trials - A systematic review. PLoS One. 2018; 13(8):e0203127. PMC: 6114918. DOI: 10.1371/journal.pone.0203127. View

12.

Brunsdon D, Biesty L, Brocklehurst P, Brueton V, Devane D, Elliott J . What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study. Trials. 2019; 20(1):593. PMC: 6794792. DOI: 10.1186/s13063-019-3687-7. View

13.

McPherson S, Rost F, Sidhu S, Dennis M . Non-strategic ignorance: Considering the potential for a paradigm shift in evidence-based mental health. Health (London). 2018; 24(1):3-20. DOI: 10.1177/1363459318785720. View

14.

Chevance A, Ravaud P, Tomlinson A, Le Berre C, Teufer B, Touboul S . Identifying outcomes for depression that matter to patients, informal caregivers, and health-care professionals: qualitative content analysis of a large international online survey. Lancet Psychiatry. 2020; 7(8):692-702. DOI: 10.1016/S2215-0366(20)30191-7. View

15.

Gallagher B, Foley M, Slattery C, Gusciute G, Shanahan E, McLoughlin D . Ketamine as an adjunctive therapy for major depression - a randomised controlled pragmatic pilot trial (Karma-Dep Trial). HRB Open Res. 2022; 3:90. PMC: 8729188. DOI: 10.12688/hrbopenres.13182.2. View

16.

Staley K, Kabir T, Szmukler G . Service users as collaborators in mental health research: less stick, more carrot. Psychol Med. 2012; 43(6):1121-5. PMC: 3642719. DOI: 10.1017/S0033291712001663. View

17.

Sforzini L, Worrell C, Kose M, Anderson I, Aouizerate B, Arolt V . A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Mol Psychiatry. 2021; 27(3):1286-1299. PMC: 9095475. DOI: 10.1038/s41380-021-01381-x. View

18.

Russell J, Fudge N, Greenhalgh T . The impact of public involvement in health research: what are we measuring? Why are we measuring it? Should we stop measuring it?. Res Involv Engagem. 2020; 6:63. PMC: 7592364. DOI: 10.1186/s40900-020-00239-w. View

19.

Gillies K, Chalmers I, Glasziou P, Elbourne D, Elliott J, Treweek S . Reducing research waste by promoting informed responses to invitations to participate in clinical trials. Trials. 2019; 20(1):613. PMC: 6819580. DOI: 10.1186/s13063-019-3704-x. View

20.

Fried E, Flake J, Robinaugh D . Revisiting the theoretical and methodological foundations of depression measurement. Nat Rev Psychol. 2023; 1(6):358-368. PMC: 10723193. DOI: 10.1038/s44159-022-00050-2. View