Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial

Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial

Trials, June 2015

26044879

Sunny Collings, Fiona Mathieson, Anthony Dowell, James Stanley, Simon Hatcher, Felicity Goodyear-Smith, Brigitte Lane, Amy Munsterman

Although mild to moderate mental health concerns are a common and often debilitating presentation in primary care settings in New Zealand (NZ), treatment options are often severely limited for this patient group. Previously, we developed an ultra-brief intervention ("UBI") for mild to moderate psychological concerns, designed to be delivered by primary care clinicians. Recent feasibility testing, including an adaptation for Māori individuals, who are the indigenous people of New Zealand, showed that the brief intervention was feasible and acceptable to both clinicians and their patients. This protocol describes a large pragmatic randomised controlled trial of UBI in primary care settings across the greater Wellington region, compared to practice as usual. We are using a two-arm cluster randomised controlled trial, with primary care practices randomised to exclusively deliver either the UBI or practice as usual to all their recruited participants. The structured, guided self-help UBI is delivered in three brief General Practitioner (GP) appointments over a five week period. Participants are invited into the study based on partner Primary Health Organisation (PHO) access criteria (youth, people with low income, or people with Māori or Pacific Island heritage). Improvements in mental health from baseline to post-treatment will be compared between the intervention and control groups using a mixed models application of analysis of covariance. Data analysis will be on an intention-to-treat basis, to increase the real-world relevance of UBI and to meet the study's objective of releasing UBI to primary care clinicians nationwide. UBI is a first line intervention tool for GPs that models the stepped-care approach advocated in NZ, against a background of limited access to treatments for this often overlooked patient group. UBI is proposed to be accessible to clinicians and patients alike, with the potential to be relevant to primary care clinicians across NZ. Australian New Zealand Clinical Trials Registry. Registration number: ACTRN12613000041752 ; Date registered: 14/01/2013.