Challenges and solutions to participation in mental health clinical trials: Count Me In 2.0

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Bifarin, O orcid iconORCID: 0000-0002-8247-2508, Bryant, T, Harvey, M, Smith, K, Miah, J, Thai, J, Ramjaun, G, Edwards, S, Jones, H, Cipriani, A orcid iconORCID: 0000-0001-5179-8321 and Joyce, DW orcid iconORCID: 0000-0002-9433-5340 (2026) Challenges and solutions to participation in mental health clinical trials: Count Me In 2.0. BMJ Mental Health, 29 (1). pp. 1-4. ISSN 2755-9734

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Abstract

Mental health clinical trials in the UK face significant recruitment barriers, with mental health studies comprising just 3.3% of approved interventional medicinal product trials. Challenges include the limited numbers of trials and clinician gatekeeping—where clinicians decide whether or not to inform patients about research opportunities, limiting patient awareness and recruitment. The ‘Count Me In’ (CMI) approach, an opt-out recruitment model launched in Oxford in 2021 and then in Liverpool City Region in 2024, aimed to address these issues by directly contacting patients to discuss research opportunities, empower them in the shared decision process and embed participation in research into real-world clinical care. In this paper, we discuss the need for advancing beyond the original CMI model, including the requirement for enhanced data capture, mechanism for patient outreach that prioritises inclusive practices for improving participation and ensuring diverse, representative trial populations.

Item Type: Article
Subjects: R Medicine > RT Nursing
Divisions: Nursing and Advanced Practice
Publisher: BMJ
Date of acceptance: 15 December 2025
Date of first compliant Open Access: 26 January 2026
Date Deposited: 26 Jan 2026 11:36
Last Modified: 26 Jan 2026 11:36
DOI or ID number: 10.1136/bmjment-2025-302355
URI: https://researchonline.ljmu.ac.uk/id/eprint/27963
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