CANCELLED - What is the clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care ? : a randomized controlled trial.

Problem

Although mild to moderate mental health problems are common and often debilitating, treatment options in primary care settings in are often severely limited for patients with these conditions.

We have developed an ultra-brief intervention (UBI) to address mild to moderate psychological concerns, designed to be delivered by primary care clinicians in a modified General Practice consultation setting. Feasibility testing, including an adaptation for Māori individuals (the indigenous people of New Zealand), showed that the brief intervention was feasible and acceptable to both clinicians and their patients. This presentation describes the findings of a pragmatic randomized controlled trial of our UBI in primary care settings, compared with practice as usual.

Approach

The study design uses a two-arm cluster randomized controlled trial, with primary care practices randomized to exclusively deliver either the UBI or practice as usual to patients determined by their General Practitioner (GP) to have a mild to moderate mental health problem. The structured, guided self-help UBI is delivered in three brief GP appointments over a five week period. Improvements in mental health from baseline to post-treatment were compared between the intervention and control groups.

Trial outcomes are:

1. To compare mental health state (as measured by K10 scores) at 26 weeks between the UBI and practice-as-usual study arms.

2. To compare levels of distress (depression and anxiety) and functioning (work, social and relationship) at 8 and 12 weeks between the UBI and practice-as-usual study arms.

Findings

189 patients, 112 GPs and 41 practices in an urban region of New Zealand were recruited to the trial, and 134 patients completed their 6 month participation.

Despite active recruitment strategies, reaching the recruitment target of 240 patients proved challenging. In keeping with results from the pilot development study of the acceptability of UBI, 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) improved.

Final follow up of recruited patients is being completed and initial analyses of the Randomised Trial will be presented , together with a discussion of the challenges of achieving recruitment targets within a context of rapidly changing primary mental health care provision.

Consequences

A feasible and acceptable brief intervention to address mild to moderate mental health problems in primary care settings, has been developed which can be delivered by General Practitioners and Practice Nurses with a total patient contact time of one hour. The intervention has the potential to be an important part of a stepped care approach to the management of common mental disorder in primary care.