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Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial
- Source :
- Trials
- Publication Year :
- 2015
- Publisher :
- Springer Science and Business Media LLC, 2015.
-
Abstract
- Background Although mild to moderate mental health problems are common and often debilitating, treatment options in primary care settings in New Zealand are often severely limited for patients with these conditions. Previously, we developed an ultra-brief intervention (UBI) to address mild to moderate psychological concerns, designed to be delivered by primary care clinicians. Recent 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 protocol describes a large pragmatic randomized controlled trial of our UBI in primary care settings across the greater Wellington region, compared with practice as usual. Methods/Design We are using a two-arm cluster randomized controlled trial, with primary care practices randomized 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 organization 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. Discussion The UBI is a first-line intervention tool for GPs that models the stepped care approach advocated in New Zealand, against a background of limited access to treatments for often-overlooked patient groups. It is proposed to be accessible to clinicians and patients alike, with the potential to be relevant to primary care clinicians across New Zealand. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12613000041752.
- Subjects :
- Adult
Male
Research design
medicine.medical_specialty
Native Hawaiian or Other Pacific Islander
Time Factors
Adolescent
Office Visits
General Practice
MEDLINE
Medicine (miscellaneous)
brief intervention
guided self-help
law.invention
Study Protocol
Appointments and Schedules
Young Adult
Clinical Protocols
Randomized controlled trial
Predictive Value of Tests
law
Intervention (counseling)
Health care
medicine
Humans
Pharmacology (medical)
Aged
Māori mental health
Psychiatric Status Rating Scales
Intention-to-treat analysis
Primary Health Care
business.industry
Mental Disorders
Syndrome
Middle Aged
Mental health
Intention to Treat Analysis
Mental Health
Treatment Outcome
Research Design
Family medicine
Physical therapy
Psychotherapy, Brief
Female
mild to moderate psychological distress
Brief intervention
business
New Zealand
Subjects
Details
- ISSN :
- 17456215
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- Trials
- Accession number :
- edsair.doi.dedup.....5953aacfd60551ab6454572f38e11d65
- Full Text :
- https://doi.org/10.1186/s13063-015-0778-y