Delivering a Self-Harm Feasibility Study under COVID

Just over a year ago we suspended the FReSH START feasibility study, as the COVID pandemic hit and lockdown was introduced. This was disappointing but of course, the only option given the severity of the situation and the need to prioritise and protect NHS staff and resources. Thankfully the feasibility study had only just opened and we had not yet recruited any participants. Suspending the study was not in itself difficult. It did however raise some questions about what to do next. Would it be possible to continue under COVID conditions?

There were several issues at play. First and foremost, would the sites we were working with want to go ahead with the study? Clinical teams were stretched, some were shielding, others were redeployed, and although there was an initial drop in A&E attendances, numbers were rising again. Would clinical staff be prepared to take on the additional work of a research study? How did they feel about it?

The next consideration was whether we could deliver the therapy during a pandemic. Online, telephone and face-to-face delivery (while wearing protective equipment) are accompanied by challenges, such as reading non-verbal cues, building the client-therapist relationship, and participant safety. Would any of these options be acceptable to the participants, therapists and their clinical teams? We also needed to know whether the therapy would be true to the FReSH START model despite these challenges.

If the above issues could be addressed, and both the clinical teams and the potential participants were happy to go ahead, there were still many practical obstacles to overcome: recruiting participants on the phone, rather than in-person home visits, and how we might keep people safe while filling out our assessments with them remotely; secure data management with all teams working from home; rewriting the training programmes for remote delivery. The list of minor adaptations was endless!

So how did we get answers? We started speaking to people. We spoke to our sites and clinical teams. We checked they had capacity and willingness to go ahead, and tried to better understand what challenges they faced on the ground. At the same time, we set up a regular online meeting, inviting members of third sector organisations and people with lived experience to join us to talk about the challenges they were facing during lockdown. This group was instrumental in helping us to understand the support needs of people who repeatedly self-harm, their experiences of accessing services (both face to face and remotely), and how we could adapt our study to effectively deliver therapy during this period of COVID restrictions.

All these conversations showed one thing very clearly – people who multiply self-harm were calling out for a self-harm focused therapy and the clinical teams on our sites were very keen to deliver this. We were inspired and invigorated by these conversations. They spurred us on to find solutions and get the feasibility study up and running again.

We adapted the training programme, and trained all our therapists online. We moved our baseline assessments and informed consent to phone calls. To address concerns around participant safety during recruitment calls, we put together a process for assessing a participant’s immediate welfare, with clear instructions of who to contact if the researcher conducting the call was concerned. We also completed a safety plan with them in case they wished to seek support after the call.  Our outstanding clinical trials team found solutions for remote data management, and moved all our processes online. Protocols, ethics, forms, informed consent documents, everything was amended and updated.

Most importantly, we worked with sites to find solutions for therapy delivery. Our final model was based on the principle of choice. Our support group highlighted choice as central to improving service accessibility; no one solution would fit everyone but being given a choice, whenever possible, would lead to fewer people being unnecessarily excluded. Our therapists and clinical teams have taken every effort to offer a choice of online or face-to-face sessions, based on participant preference. This has the added benefit of allowing staff who are shielding to still be involved in the study.

While some solutions may not be perfect, and we have certainly hit some unexpected bumps along the way (more on those to come next time), there was no question that it was better to deliver something, and learn from this, than to deliver nothing. What else is a feasibility study for, if not to try new ideas and learn?

A paper discussing the full details of how we adapted the feasibility study in relation to COVID is in draft and will be available in due course.