Reports of research work funded by grants prior to 2015
University of Otago Wellington
Randomized Control Trial of an Ultra-Brief Intervention for Common Mental Health Syndromes in Primary Care.
A review of services identified a significant gap in services for mild-to-moderate symptoms of distress in primary care. In answer to this unmet need, we developed and feasibility-tested an ultra-brief intervention (UBI) which uses a guided self-help format, involving three brief, structured face-to-face sessions with a GP, supported by self-help booklets across four topics: stress management, relationships, harmful behaviours, and bodily stress. The face-to-face intervention and booklets were subsequently adapted for Māori providers and patients, and were found to be relevant and acceptable to both clinicians and patients.
Despite evidence for the individual elements within the UBI, there has been no randomised controlled trial of the effectiveness of such a therapy delivered routinely in primary care. Thus, the aim of this trial is to investigate the clinical effectiveness of the UBI for individuals who present with mild-to-moderate mental health needs in primary care settings compared with practice as usual, in a randomised controlled trial in a real-world study design.
The RCT started in May 2013 and has been running for two years. To date it has involved a total of 28 practices, 72 GPs and 125 patients. Currently participating are 25 practices (three practices had a single participating GP who left the practice), 58 GPs (14 left the practice) and 83 patients (42 withdrew or were excluded). A sample size of 240 was calculated using a simulation approach based on standard deviations from the UBI development study, which means that the RCT is approximately half way through.
The recruitment rate has been slow for a number of reasons. Firstly, the study is only open to patients who meet the funding criteria for our partner primary health organisation, Compass Health. As a service funder, Compass Health is only able to fund intervention sessions for people within its contract for provision of Primary Solutions, namely youth, people on low incomes, and individuals from Māori or Pacific Island cultural backgrounds. These service funding criteria have, however, by their restricted nature reduced recruitment into the RCT. We proposed providing additional funding to increase access into the study by broadening the criteria to all clinically eligible participants in the general population, however structural and strategic changes within the organisation at that time meant that they were not in a position to resource this proposal.
Secondly, restricted eligibility criteria have resulted in a necessary extension of the study timeframe, which is likely to have impacted the attrition of GPs participating in the trial.
Thirdly, many GPs reported that they themselves have been under stress; that their practice is under-staffed and under-resourced, and that research projects in general had become less of a priority.
However enthusiasm for the intervention has not waned. Participating GPs continue to provide strong anecdotal support for the UBI and many have been actively encouraging colleagues to give it a try: “my involvement in the study has given me a lot of helpful new ideas and consultation skills to try out in my mental health consults generally, and I expect you would have a similar experience.” Positive feedback like this has given us the impetus to keep developing new and innovative ways to promote the study and boost recruitment.
A key initiative has been to extend participation to GPs outside Compass Health, to include non-Primary Solutions patients and non-Compass Health practices in Lower Hutt, Porirua, the Kapiti Coast and the Wairarapa. The current recruitment drive has resulted in 13 new practices joining the study and over 30 new GPs signing up, with more expressions of interest presently being received. We anticipate that in addition to those participants currently being referred to the study by existing GPs, over 60 patients will be recruited by the end of 2015, and we hope to complete the trial in 2016.
In addition to the continuing positive feedback given by participating GPs, preliminary results from audit trails provided to GPs indicate that the mental health state of patients who received the intervention (as measured by K10 scores) has improved. However, full data analysis will not be conducted until all data has been collected at the end of the trial.
If the effectiveness of the intervention is supported by this trial, we plan to make the intervention widely available. It will make a significant difference to clinical practice and patient outcomes in New Zealand. Despite the challenges inherent in any full-scale trial, our vision is that the UBI will form part of the standard skillset for all primary care clinicians in New Zealand (and potentially internationally: there have already been requests for the intervention package from Australia).