Data collection
The primary data collected were:
- Recruitment rates per month (referred, consented and randomised) and attrition rates.
- Intervention engagement (e.g., session attendance) and participant, GP staff and Assistant Psychologist acceptability.
- Clinical assessments completeness (questionnaires and health-resource use).
- Frequency of patient risk and safeguarding incidents reported.
The clinical assessment questionnaires completed were:
- PHQ-9, a measure of depression
- GAD-7, a measure of anxiety
- Warwick and Edinburgh Wellbeing Scale (WEMWBS), a measure of wellbeing
- Brief Resilience Scale (BRS), a measure of resilience
Results
The study write up has now been published in the journal of 'Mental Health & Prevention' and the full article can be found here- 'Mental health prevention and promotion in general practice settings: A feasibility study.'
All of the progression criteria were classified as 'amber' meaning that progression to a larger randomised controlled trial is warranted but with some changes to improve recruitment, intervention engagement and participation retention.
Data Access Statement
Data availability: The data used to support the findings can be accessed by request via contact us.
Restrictions: Data at an individual level will not be made available in order to protect patient confidentiality.
Further information: To discuss access to restricted data please contact us.
During the 6-month recruitment period, 230 potential participants were screened for eligibility. Of these, 72 were eligible and able to join the study. 64 participants were randomised into either the ‘treatment as usual’ or ‘intervention’ study arm, surpassing the recruitment target of 60 participants.
Three months after the end of the intervention, 22 people had dropped out of the study: 10 from the ‘intervention’ arm and 12 were in the ‘treatment as usual’ arm.
People gave different reasons for withdrawing from the study. In the ‘intervention arm’ 2 said they no longer needed the support, 2 had therapy appointments elsewhere and wanted to take that offer up instead and 5 became uncontactable. In the ‘treatment as usual’ arm, 2 said they were disappointed with being allocated to the ‘treatment as usual’ arm as opposed to the ‘intervention’ arm, 2 said they no longer required support, 1 was receiving counselling elsewhere so declined and 5 were uncontactable.
Participants, General Practice staff and Assistant Psychologists from the research team were interviewed to understand the challenges and facilitators of the study. This qualitative data was analysed and key themes emerged.
Participants highlighted the compassionate and therapeutic relationships developed during longer appointment slots, the ease of access and locality of the appointments, and the helpful content that aided in managing their emotional well-being and understanding. Some participants expressed a desire for more than 4 sessions, while others appreciated the short, focused nature of the intervention, which motivated them to actively participate, knowing it was time-limited.
General Practice staff reflected that it was good to have a preventative offer for mental health, as well as physical health in the surgery. Colleagues felt that the different approach integrated well into General Practice, particularly as the multi-disciplinary team in General Practice is growing. Staff believed that more patients should receive the offer and that they also gained valuable knowledge from the research conducted within their practice.
The Assistant Psychologists delivering the intervention enjoyed the work and felt satisfied when they could help people work towards better emotional well-being. At the start of the study, they reflected upon the challenge of integrating themselves and the study into General Practice, as they were new staff and no other Assistant Psychologists worked within General Practice.
Further detail and quotes from the study can be found in the published article.
For participants who stayed in the study, all completed the required measures (questionnaires).
As a feasibility study, the aim was not to demonstrate between-group effectiveness. However, early results indicated that for the participants who received the intervention, the average WEMWBS score increased by more than 7 points at 16-weeks post-baseline and both the PHQ-9 and GAD-7 scores decreased by around 3.5 points by week 16. The increase in the WEMWBS and decreases in the PHQ-9 and GAD-7 demonstrate improved well-being. The BRS score increased only marginally.
In the ‘treatment as usual’ arm, none of the average scores had improved greatly (if at all) by week 16.
The resource use data was collected for 100% of the randomised participants at baseline and 96.88% of participants at follow-up.
During the study, there were four documented examples of care initiated as a result of presenting risk or safeguarding concerns. Either the ‘Duty Doctor’ or safeguarding lead within General Practice was able to appropriately support the Assistant Psychologist with no further action required.
What have we learnt from this feasibility study?
The purpose of completing a feasibility study is to identify improvements for the research before conducting a larger trial.
This study demonstrated that it is feasible to deliver a brief psychological intervention, focusing upon mental health prevention and promotion in General Practice.
There have been some important learnings from the MEND study, some of these were:
- Incentives for follow-up: Offering an incentive to participants for returning to follow-up appointment could help reduce attrition rates. This is particularly the case for the ‘treatment as usual’ group, who did not receive the intervention.
- Training and integration: It was possible to train staff (Assistant Psychologists) who had no prior experience of the brief intervention to successfully deliver the approach. However, these new staff members initially struggled to integrate into General Practice due to their unfamiliarity with the setting and the absence of other Assistant Psychologists. Therefore, in the future study, given the expansion of roles and the growing multi-disciplinary team (MDT) in General Practice, existing staff members will be trained to deliver the preventative intervention. Colleagues such as social prescribers and mental health practitioners are well placed to do so. These colleagues, already well embedded in General Practice, will allow for a smoother start and ongoing collaboration with other General Practice colleagues. Providing additional skills and training to such colleagues in a preventative approach would also offer a more realistic opportunity for wider adoption.
- Appropriate Referrals: Referrals into the study made by General Practice staff were generally more appropriate (e.g., potential participants met the inclusion criteria for the study). Having General Practice staff join the study team and deliver the intervention will likely further improve recruitment rates.
- Recruitment timing: The time of year impacted upon recruitment. With the lowest recruitment rates occurring during August (the summer holidays) and December.
- Improving access for all: Additional efforts are needed to improve access rates for individuals from ethnic minority backgrounds. There are opportunities to work within community settings (e.g., use space in community hubs) and these should be built upon in a larger study. Again, having General Practice staff, who are well integrated into the community would likely help with this.
- Data collection: The questionnaires and resource-use information was easily collated. However, there was a query about the sensitivity of the BRS in measuring change, so its future inclusion in a trial should be considered carefully.
- Safety: Safety incidents could be well managed within the existing structures of General Practice.
- The benefit for individuals: Perhaps most importantly, there was a lot of positive feedback from people who accessed the intervention, with early indication of improvements in well-being. This highlights the benefit and importance of such early work in General Practice settings.
- The benefit for General Practice staff: In addition, feedback from General Practice colleagues was positive. Staff advised that this intervention should be more readily available to more people. Staff reported that the increasing demand for mental health support is creating pressure on services, and they are concerned about the distress people are experiencing. There was therefore a clear wish for improvement and support for action to change.