title: Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12613000041752.
authors.affiliation: Office of the Dean and Head of Campus Te Tari Manutaki, Department of Psychological Medicine, University of Otago, PO Box 7343, Wellington South, 6242, New Zealand. deanseauow@otago.ac.nz.
authors.forename: Sunny
authors.initials: S
authors.lastname: Collings
authors.affiliation: Department of Psychological Medicine, University of Otago, PO Box 7343, Wellington South, 6242, New Zealand. fiona.mathieson@otago.ac.nz.
authors.forename: Fiona
authors.initials: F
authors.lastname: Mathieson
authors.affiliation: Department of Primary Health Care and General Practice, University of Otago, PO Box 7343, Wellington South, 6242, New Zealand. tony.dowell@otago.ac.nz.
authors.forename: Anthony
authors.initials: A
authors.lastname: Dowell
authors.affiliation: Biostatistical Group, Dean's Department, University of Otago, PO Box 7343, Wellington South, 6242, New Zealand. james.stanley@otago.ac.nz.
authors.forename: James
authors.initials: J
authors.lastname: Stanley
authors.affiliation: Department of Psychiatry, University of Ottawa, 1145 Carling Avenue, Ottawa, ON, K1Z 7K4, Canada. shatcher@uottawa.ca.
authors.forename: Simon
authors.initials: S
authors.lastname: Hatcher
authors.affiliation: Department of General Practice and Primary Health Care, University of Auckland, Private bag 92019, Auckland Mail Centre, Auckland, 1142, New Zealand. f.goodyear-smith@auckland.ac.nz.
authors.forename: Felicity
authors.initials: F
authors.lastname: Goodyear-Smith
authors.affiliation: Department of Psychological Medicine, University of Otago, PO Box 7343, Wellington South, 6242, New Zealand. brigitte.lane@otago.ac.nz.|Registered psychotherapist in private practice, Wellington, New Zealand. brigitte.lane@otago.ac.nz.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Lane
authors.affiliation: Registered psychotherapist in private practice, Wellington, New Zealand. amyemunsterman@gmail.com.|Formerly at Compass Health Primary Health Organization, Wellington, New Zealand. amyemunsterman@gmail.com.
authors.forename: Amy
authors.initials: A
authors.lastname: Munsterman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001071:Appointments and Schedules; D002985:Clinical Protocols; D005260:Female; D058006:General Practice; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D001523:Mental Disorders / Q000175:diagnosis / Q000208:ethnology / Q000523:psychology / Q000628:therapy*; D008603:Mental Health; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D009819:Office Visits; D011237:Predictive Value of Tests; D011320:Primary Health Care; D011569:Psychiatric Status Rating Scales; D011614:Psychotherapy, Brief / Q000379:methods*; D012107:Research Design; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult