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Diverse recruitment in randomised clinical trials

Diverse recruitment in randomised clinical trials

By Rimsha Parvaiz, Research Assistant on the SASH Study

Introduction

Randomised controlled trials (RCTs) play a pivotal role in strengthening psychological interventions within the NHS by providing robust, unbiased evidence on effectiveness and safety of treatments. They help identify what works, for whom, under what conditions, establish causality, inform NICE guidelines, support cost-effectiveness decisions, improve service delivery, reduce wasted resources, and enable the evaluation of new or adapted treatments 1,2,3,4. Through working on three RCTs as a research assistant, focused on improving mental health outcomes and overall wellbeing in individuals experiencing significant psychological difficulties, I gained first-hand insight into both the value of research and the challenge of conducting it inclusively. With a particular interest in supporting inclusive recruitment, this work offered an opportunity to reflect on how inclusion operates in practice. Inclusive research aims to actively involve diverse populations across the research process to ensure findings are relevant, equitable and effective. Inclusive research is essential because underserved groups often experience a higher burden of illness but are underrepresented in studies, despite benefiting most from effective interventions. Including them improves understanding of how age, ethnicity, socioeconomic status, and culture affect psychological health and treatment response, and helps ensure interventions are relevant, effective, and reduce health inequalities 2. This blog reflects on three trials to explore how inclusion operates in practice and why intentional strategies do not always lead to the outcomes expected.

Recruitment approaches

Having worked on three RCTs I was actively involved in recruitment and engagement with an interest in promoting inclusivity. Each trial adapted its own approach to inclusion.

One trial developed a structured strategy to explicitly focus on ethnic minority recruitment through reviewing study materials for cultural sensitivity, community outreach through third-sector organisations and involving advisory groups with lived experience input. These approaches were to ensure materials, engagement and ideas were paved by people in underrepresented groups. The research team itself was also representative of the populations the study sought to engage. Although recruitment of ethnic minority individuals was low, the study helped raise awareness of mental health and improve access within community spaces, reaching participants who face barriers to accessing NHS services, including those with prior negative experiences. This was achieved by engaging directly with community settings not typically associated with the NHS, including youth centres, faith groups, and community centres, as well as attending local events and presenting within inclusive services. Awareness was further supported through inclusive posters and leaflets, social media outreach, and offering flexible participation options, enabling engagement in accessible, non-clinical environments.

This approach highlighted the importance of meeting people in familiar community spaces to improve engagement, particularly for those with negative experiences of NHS services. It also reinforced the value of building trust through community partnerships, using inclusive and accessible materials, and adapting recruitment strategies to effectively reach underserved groups.

In contrast the ASSURED and SASH studies, which focused on recruiting individuals experiencing self-harm and/or suicidal ideation, did not begin with a formal inclusion strategy. Instead, recruitment took place in areas with a highly diverse population and benefited from established referral pathways within crisis services. All potentially eligible participants were contacted following presentations to emergency departments, with recruitment carried out alongside existing care pathways. As the study progressed, practical adaptations were introduced in response to recruitment challenges e.g. participant-practitioner pairing which is discussed further below. Despite the structural differences, the ASSURED and SASH studies recruited a significant number of ethnic minority participants.

Taken together, these experiences highlighted that while structured community-based approaches worked well in building trust and raising awareness, they did not always translate into higher recruitment numbers. This suggests that both strategic planning and contextual factors play different but complementary roles in shaping recruitment outcomes.

Recruitment challenges: Male participation

Across all studies, recruiting male participants proved challenging with only 10-20% of those recruited identifying as male. Working behind the scenes of recruitment highlighted several factors that may have contributed to underrepresentation. Talking therapies and mental health are often socially associated with emotional openness, which can conflict with dominant norms of masculinity. As a result, interventions centred on discussing feelings may feel less accessible or appealing to some men. Existing research supports this, with Seidler et al (2016) suggesting that men may perceive engagement with mental health research as threatening to masculine norms. Having worked alongside crisis team to identify eligible participants, it became clear that the way male distress is interpreted within clinical settings can significantly shape access to research. In some services, male distress was more likely to be understood and recorded as physical or behavioural rather than emotional. This reflects evidence that self-harm is not always consistently identified or coded in emergency settings, with presentations sometimes recorded as aggression or behavioural disturbance rather than self-harm, contributing to under-recognition, particularly in men 6,7. As a result, male participants were often escalated to higher intensity services such as specialist community mental health teams or crisis services, which automatically excluded them from the study. In addition, the categorisation of self-harm appeared to differ by gender. While both studies adopted a broad understanding of self-harm, recognising that it can present in many forms, this definition was not always reflected in clinical decision-making. Behaviours such as punching walls or other forms of physical injury were frequently interpreted as expressions of anger or violence rather than self-harm or attempts to injure oneself. This mismatch between research definitions and clinical interpretations meant that some males who may have been eligible in principle were excluded in practice. This is consistent with research distinguishing between externalising and internalising expressions of distress, where externalising behaviours are more likely to be recognised clinically, potentially leading to under-identification of self-harm when it presents in less overt forms 6,8. Together these observations highlight how structural and interpretative processes within services can unintentionally limit male participation in research, even when studies aim to be inclusive. To address these challenges, we introduced several practical strategies. Clinical teams were reminded of the study’s inclusive definition of self-harm, though bias in interpretation remained. Where possible, male participants recruited were paired with male researchers and therapists to make engagement more approachable and relatable. We were also keen to interview male participants about their experience and motivations for taking part, to better understand and improve recruitment for future studies.

Takeaways for future research

There are many important insights from these trials. Neither one is inherently more effective than the other, rather, inclusive research requires a combination of context sensitive design, awareness of structural bias and close collaboration with clinical teams. Recruitment outcomes are shaped not only by planned strategies but also by factors such as study location, existing service networks and the trust participants have in those delivering the study. Efforts to engage underrepresented groups, such as matching male participants with male researchers or involving lived experience advisory groups, can help reduce barriers, but they do not guarantee participation on their own. Importantly, inclusion is about more than numbers: even when target recruitment is not met, being present in inclusive spaces, building relationships and creating opportunities for participation represents meaningful progress. Small changes, such as improving access, widening definitions of self-harm and normalising conversations about mental health in community or clinical settings, can have a significant impact on individuals and on the broader culture of research participation. Ultimately, these experiences reinforced that inclusive research is an ongoing process that needs to adapt to the people, places and communities involved, that values relationships, flexibility and meaningful engagement over numbers alone and that strives to create research spaces where all voices can be heard. As a researcher, this experience deepened my understanding of recruitment, highlighting the importance of adaptability, trust-building, and community engagement, and shifting my perspective to value process and inclusion alongside recruitment outcomes.

References

  1. Cooper M. The role of randomised controlled trials in developing an evidence-base for counselling and psychotherapy. Counselling and Psychotherapy Research. 2012. https://doi.org/10.1080/14733145.2012.687388
  2. Hariton E, Locascio JJ. Randomised controlled trials—the gold standard for effectiveness research. BJOG: An International Journal of Obstetrics & Gynaecology. 2018. https://doi.org/10.1111/1471-0528.15199
  3. Kendler KS. The relationship between social support and mental health. The British Journal of Psychiatry. 2017. https://doi.org/10.1192/bjp.2017.18
  4. House of Commons Health Committee. Health: Written evidence (HC 503). UK Parliament. 2007. Available from: https://publications.parliament.uk/pa/cm200607/cmselect/cmhealth/503/503we18.htm
  5. National Institute for Health and Care Research. Improving inclusion of under-served groups in clinical research: Guidance from the NIHR-INCLUDE project. 2020. Available from: https://www.nihr.ac.uk/documents/improving-inclusion-of-under-served-groups-in-clinical-research-guidance-from-include-project/25435
  6. Jakobsen SG, Andersen PT, Lauritsen J, Larsen CP, Stenager E, Christiansen E. Opening the black box of registration practice for self-harm and suicide attempts in emergency departments: A qualitative study. BMC Primary Care. 2024;25:139. https://doi.org/10.1186/s12875-024-02393-6
  7. Lawrence RE, Fuchs B, Krumheuer A, Perez-Coste M, Loh R, Simpson SA, Stanley B. Self-harm during visits to the emergency department: A qualitative content analysis. Journal of Affective Disorders. 2022. https://doi.org/10.1016/j.jaclp.2021.10.003
  8. Smith DT, Mouzon DM, Elliott M. Reviewing the assumptions about men’s mental health: An exploration of the gender binary. American Journal of Men’s Health. 2016;12(1):78–89. https://doi.org/10.1177/1557988316630953

 

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