Addressing the Challenges of Recruitment and Retention in Sleep and Circadian Clinical Trials.

ABSTRACT

Objective/Background: Sleep and circadian disorders are prevalent worldwide and frequently comorbid with physical and mental illnesses. Thus, recruiting and retaining samples for sleep and circadian research are high priorities. The aims of this paper are to highlight barriers to recruitment and retention for participants with sleep or circadian dysfunction, and to share strategies used across two randomized controlled trials (RCTs) testing the efficacy of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) to address these challenges. Participants: The first RCT recruited 176 adolescents with an evening circadian chronotype, who were at risk in at least one of five health domains behavioral, cognitive, emotional, physical, and social. The second RCT recruited 121 low-income, racial or ethnic minority adults diagnosed with severe mental illness (SMI) and comorbid sleep or circadian dysfunction. Methods: The current study examined participant, environment, and research factors that impacted recruitment and retention of participants with sleep or circadian dysfunction, and identified strategies to enhance recruitment and retention. Results: Strategies used to recruit participants included community-based recruiting, reducing stigma, and alleviating burdensome sleep data collection. Strategies used to retain participants in our studies included flexible scheduling, mitigating participant barriers, building rapport with participants through empathic and positive interactions, creative problem solving, consulting participant networks, and utilizing incentives and other positive engagement tools. Conclusion: Both at-risk adolescents and low-income, minority adults with comorbid SMI and sleep or circadian dysfunction experience significant barriers to research participation. Recruitment and retention strategies were creatively tailored to meet the unique barriers of these diverse populations.