Democratising patient and public involvement – A case study from the RELAX (Reducing Levels of AnXiety) randomised clinical trial

Anxiety during pregnancy and the early months of parenting is a widespread public health challenge, affecting more than one in five women in the United Kingdom. For many, these worries do not reach the threshold of a severe disorder requiring immediate clinical intervention, yet they are heavy enough to disrupt daily life and family bonding. In response, researchers have developed psychological training designed to help individuals reframe negative thoughts and prevent anxiety from escalating. However, for such training to work, it must be designed in a way that feels relevant and accessible to the very people it aims to help. This requires more than just scientific expertise; it demands the active participation of the community. This approach, known as patient and public involvement, treats people with lived experience not as passive subjects of study, but as essential partners who help shape the research from the ground up. The question facing the scientific community is not just whether this partnership improves the data, but how to build a system where diverse voices are truly heard, valued, and empowered throughout the entire process.

A recent case study from the RELAX trial, a large clinical study testing a psychological training program for perinatal anxiety, offers a detailed look at how this partnership can function in practice. The researchers set out to involve a diverse group of parents who had experienced anxiety during pregnancy, aiming to make the trial more relevant, reduce barriers to participation for underrepresented groups, and improve the overall quality of the study. What emerged was a process that evolved from simple consultation into a genuine collaboration, where the boundaries between researchers and the public began to blur. The study involved a large advisory group of nineteen individuals, including mothers, fathers, and a birthing parent who was transitioning from female to male, representing a wide range of ethnic backgrounds, including Black and Asian communities. These advisers were not merely asked for their opinions once; they were paid for their time, reimbursed for travel and childcare, and invited to attend twenty-eight meetings over the course of the study.

The core of the RELAX project's success lay in how the research team responded to the needs and ideas of this advisory group. Rather than sticking rigidly to a pre-set plan, the researchers demonstrated a flexible responsiveness that allowed the public involvement to grow. For instance, when advisers expressed a desire for more frequent meetings, the team doubled the number of sessions. When advisers suggested that the study materials needed to be clearer and less intimidating, the team rewrote the website and training scenarios to use plain language and remove triggering content. A significant innovation was the creation of a WhatsApp group, which served as a digital community space where advisers could support one another, share updates, and build relationships between formal meetings. This informal network helped to foster a sense of belonging, turning a group of strangers into a cohesive team with a shared mission.

The impact of this approach was tangible and measurable. The advisory group's input directly influenced the design of the study's marketing materials, which featured ethnically diverse women and relatable imagery rather than idealized models. This shift helped the trial recruit 268 participants over thirteen months, a pace that the researchers attribute in part to the community endorsement provided by the advisers. Furthermore, the trial achieved unusually high retention rates, with between 93 and 96 percent of participants completing their follow-up assessments. The advisers felt that their presence and advocacy helped researchers understand the real-world demands on new mothers, leading to adjustments that made the study more manageable for participants. One specific example involved the advisers advocating for an extension of the study timeline to ensure that those who joined later could still complete the final assessments, a decision that prioritized equity over strict scheduling.

Beyond the recruitment numbers, the study revealed a profound transformation in the people involved. The advisers reported feeling valued and respected, describing a shift from feeling like outsiders to feeling like equal team members. Many found that contributing to the research gave them a sense of agency, allowing them to turn their own difficult experiences with anxiety into something constructive for others. Several advisers were invited to go beyond their advisory roles and participate in the actual analysis of the data, helping to code and interpret the findings. This level of involvement, where public members co-authored scientific papers and presented at conferences, is rare in the field. The researchers noted that this partnership also changed their own perspective, giving them a deeper, more human understanding of the anxiety they were studying and the importance of inclusivity in research design.

However, the path to this success was not without its hurdles. The researchers acknowledged that they underestimated the amount of time and resources required to maintain this level of engagement. While the study made significant strides in diversity, some advisers expressed disappointment that the training could not be accessed via smartphones, a limitation that was initially decided upon due to concerns about distraction, though a smartphone app is now being developed. Others noted that the initial design of the trial, including the specific statistical methods, was decided by the researchers before the public was fully brought on board, meaning that the deepest level of shared decision-making was not achieved in the earliest stages. Additionally, some advisers felt shy about speaking up in large online meetings, suggesting that smaller group discussions might have helped everyone contribute more confidently.

The study concludes that the key to effective public involvement lies in a commitment to democratizing the process, where power is shared and relationships are nurtured over time. It suggests that when researchers listen with purpose, provide fair rewards, and remain open to adapting their plans, the result is research that is not only of higher quality but also more equitable. The RELAX trial demonstrates that involving the public is not just a box to be ticked for funding; it is a dynamic process that can empower individuals, build trust within communities, and ultimately lead to better health outcomes. By treating the public as partners rather than subjects, the researchers found that they could create a study that was truly relevant to the people it was designed to serve, proving that the most effective science is often the science that is done with, rather than just for, the community.