ArticleHRB open research2023
Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial.
Article in HRB open research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04939649 (Ketamine As an Adjunctive Therapy for Major Depression - a Randomised Controlled Trial), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Ketamine As an Adjunctive Therapy for Major Depression - a Randomised Controlled Trial: [KARMA-Dep (2)]
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 ( 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)].
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