Mental health clinical trials are essential for advancing our understanding and treatment of mental health conditions. However, these trials face unique challenges in recruitment and retention of volunteers and participants that can hinder their success. The recent collaboration between MQ and Boston Consulting Group (BCG) aimed to address these challenges by involving people with lived experience (PWLE) at every stage of the project.
Involving PWLE in All Stages
One of the standout features of this project was the involvement of PWLE across all stages, from design of the study to data collection, analysis, and review of the final output.
This approach ensured that the voices of those with lived experience were central to the research process, providing valuable insights and fostering a sense of ownership and empowerment among participants. The feedback from the people involved and focus groups highlighted how this project felt different, with participants appreciating the genuine engagement and thoughtful consideration of their input.
BCG, having never worked with PWLEs before, was particularly impressed by the knowledge and thoughtfulness of the living/lived experience voice throughout the project. This collaboration not only enriched the research but also set a new standard for PWLE involvement in mental health trials.
Identifying the challenges of recruitment and retention
Through a comprehensive methodology involving focus groups, expert interviews, and literature reviews, the project identified 18 recruitment and retention challenges in mental health trials. These challenges were assessed for their potential impact on recruitment and retention through thematic analysis and a survey of 100 respondents. The analysis revealed eight overarching challenges with the highest impact, including:
- Recognizing Mental Health Clinical Trials Do Not Happen in a Vacuum: Mental health trials are influenced by various external factors, including societal stigma and healthcare system limitations.
- Developing Evidence Base for Current R&R Challenges: Convening funders to mutually reinforce best practices in the entry and collation of R&R data.
Taking part in the recent MQ focus groups, has definitely been one of the great highlights of my time working as a service user researcher.
Says one of the participants of the project. “The extraordinary range of experiences and expertise that was represented by the other members ensured that the session was both revelatory and highly accessible on a wide range of complex and sometimes challenging issues around mental health clinical trials.
This was also facilitated with a combination of sensitivity, generosity, and brilliant listening skills which meant that we benefitted from hearing truly diverse perspectives. The facilitator also made us all feel that our knowledge was equally valued and respected, whether we were service users, clinical trial specialists, or consultants. I was particularly impressed by the space she enabled for experts from low and middle income countries to contribute their incredibly valuable insights’.”
Key Findings and Recommendations
The presentation highlighted several key findings and recommendations to improve recruitment and retention in mental health clinical trials:
- Landscape of Mental Health Trials: Approximately 40% of mental health trials are academia-led behavioural trials, with anxiety and depression being the most common indications.
However, mental health trials recruit below average compared to other therapeutic areas, with a higher dropout rate
- Challenges in LMICs and Marginalized Groups: Recruitment and retention are more complex in lower and lower-middle-income countries (LMICs) and for marginalized groups
These groups face additional challenges, such as increased stigma, limited cultural and language adaptation, and lack of access to education and standard care
- Digital Tools for Recruitment and Retention: Despite the availability of over 200 companies offering digital tools across 13 core use cases, adoption in mental health trials remains limited
Digital tools such as virtual visits, trial education, and participant engagement show high potential impact but require adaptation to the mental health context
- Recommendations for Funders: The presentation identified eight key areas where funders can make a significant impact, including accelerating near-term impact, lifting digital roadblocks, adapting existing digital recruitment funnels, bridging the gap on digital consent and participant education, reducing disparities, recognizing mental health trials do not happen in a vacuum, and unlocking the potential of digital endpoints
Setting a new standard
The collaboration between MQ and BCG has set a new standard for PWLE involvement in mental health clinical trials. By addressing the unique challenges of recruitment and retention, this project has provided valuable insights and actionable recommendations for improving the success of mental health trials. The integration of digital tools and the focus on marginalized groups and LMICs are particularly promising areas for future research and development. As we continue to advance our understanding of mental health, the involvement of PWLE and the adoption of innovative approaches will be crucial in ensuring that clinical trials are effective, inclusive, and impactful.