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

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.