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Research assistants' experiences recruiting patients with psychosis into clinical trials: a qualitative study

Abstract:
Objectives
Treatments for patients diagnosed with psychosis need to be improved. Clinical trials are an important way of assessing the efficacy of new treatments. However, recruiting patients into trials is challenging. This study sought to better understand the reasons for this from the perspective of research assistants.
Design
A qualitative study underpinned by a critical realist ontology and contextualist epistemology.
Methods
Research assistants who had recruited patients with psychosis into trials, primarily of psychological interventions, were interviewed. Reflexive thematic analysis was used to identify themes.
Results
Overarching themes representing four types of factors influencing recruitment of patients with psychosis into clinical trials were generated: patient, clinical team, research team, and NHS infrastructure. Patients largely wished to take part in trials but needed time to build trust with research assistants. Clinical teams held the power in suggesting patients for trials; therefore, it was essential for research teams to build strong relationships with clinical staff. Research teams recruiting into trials benefited from lived experience expertise, support systems, and institutional knowledge. A key NHS infrastructure factor was that mental health staff had limited time to consider trials for their patients.
Conclusions

Trial participation needs to be made more accessible to patients with psychosis, who often want to take part but lack opportunities. Methods of increasing accessibility could include identifying and addressing barriers to referral from clinical teams, employing multiple recruitment strategies, and flexible appointment formats. Qualitative research with clinical teams and patients will also help in developing the understanding of barriers to recruitment.

Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1186/s13063-025-08882-y

Authors

More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Experimental Psychology
Role:
Author
ORCID:
0000-0001-6026-9616
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0001-8029-1052
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Experimental Psychology
Role:
Author
ORCID:
0000-0002-2749-1386
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Experimental Psychology
Role:
Author
ORCID:
0000-0002-2541-2197


More from this funder
Funder identifier:
https://ror.org/0187kwz08
Grant:
NIHR302033


Publisher:
BioMed Central
Journal:
Trials More from this journal
Volume:
26
Issue:
1
Article number:
180
Place of publication:
England
Publication date:
2025-05-30
Acceptance date:
2025-05-10
DOI:
EISSN:
1745-6215


Language:
English
Keywords:
Pubs id:
2127811
Local pid:
pubs:2127811
Source identifiers:
W4410906742
Deposit date:
2025-06-04
ARK identifier:

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