Involvement in research and trials: the participants’ perspective

A crucial factor in making a piece of research successful or not is participant engagement. Do people want to take part and can you keep them engaged for follow-up if that is required? But very little research has been carried out of participant experiences of what’s involved in “taking part in research” and why people do. So we were pleased to read about a qualitative research study that is addressing this very issue by talking to participants in the PRODIGY trial which is a study of the prevention of long term social disability among young people with emerging mental health needs. The authors – Notley et al 2014 – have published their findings in the British Journal of Psychiatry. The full reference is:

Notley et al., (2014), Participant views on involvement in a trial of social recovery cognitive–behavioural therapy. The British Journal of Psychiatry, 1–6. doi: 10.1192/bjp.bp.114.146472

The PRODIGY qualitative study aimed to: (a) explore individual experiences of participating in the trial and initial views of therapy; and (b) explore perceived benefits of taking part in research versus ethical concerns and potential risks. The experiences of the thirteen people interviewed centred on key themes of acceptability, disclosure, practicalities, altruism and engagement. People were interviewed in both “arms” of the study – those receiving the new treatment (6 people) and those in the control group (7 people). What did they learn?

In terms of practicalities, they found it was essential for participants that researchers take a practical and measured approach to helping people participate. Twelve of the participants reported that they appreciated flexibility in research appointments, in time, location and also in being able to split the assessments in sessions that suited them in terms of length of time and content.   Those interviewed said that flexibility and a person-centred approach showed empathy on the part of the researchers and this was valued.  Three people said they would have liked more information about the length of assessments.  People were also extremely open and accepting of research procedures and measures.  Three people even identified some of the research tasks as fun.

Closely linked to the theme of acceptability was the theme of disclosure – disclosing personal and sometimes sensitive information to researchers – and what facilitates this process.  The actual disclosure dialogue was discussed as being a useful and therapeutic process in its own right.  Ten of the thirteen people interviewed felt the positive disclosure experience was the result of the researcher being supportive, non-judgemental and empathetic. Some expressed surprise at the extent of their disclosure and how natural that was, reflected as a ‘positive surprise’.

Seven people spoke at length of their keenness to be involved in research, for altruistic reasons, and there was an understanding and willingness to be involved as part of ‘helping others’ regardless of whether they received treatment or not. This was important with reference to randomisation, which was mainly well understood and accepted, though recommendations relating to this emerged as not all did. There was also concern that engagement in the study may be too demanding for people who were unwell and vulnerable, and who were socially isolated. Encouragingly, several people spoke of engagement with the research processes.  This engagement with the trial was experienced as a positive step and potentially had additional benefits through the data collection process, providing information that helped people make changes in their lives.

Overall the feedback was that involvement in research was a positive experience.

This paper was of particular interest to us at the McPin Foundation because we are about to embark on a qualitative study ourselves to look at people’s decision making processes when being invited to take part in a mental health research trial. We will be carrying out a service user led qualitative research study using the PRIMROSE project as our case study. It has been developed by the PRIMROSE Lived Experience Advisory Panel (LEAP- a group of 30 service users and carers) and will be carried out by two service user researchers supported by the LEAP coordinator (Ben Gray) and staff within the McPin Foundation.

We will explore approaches to deciding whether or not to take part in a randomized control study by interviewing 20 people who would fit the “criteria” for the PRIMROSE study that is working with people with severe mental illness at risk of cardio-vascular disease. It is only by directly exploring decision making that we might come to a better understanding of how to approach recruitment in future research trials.  The project builds on best practice principles for PPI and for co- production. We will report findings in early 2016.

Another important piece of work to mention is a discussion paper the McPin Foundation has commissioned on the limitations of RCTs. That will be out in the next few months. It is important to critically assess current research methods to drive up the quality of work undertaken across the sector. Critical assessment of our own studies, as well as our views of other work is something we actively encourage. That’s the best way to learn so do get in touch with your views on engagement and recruitment issues in mental health research studies.