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

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Mental Health*; Mental Disorders/*therapy ; Psychotherapy, Brief/*methods; Adolescent ; Adult ; Aged ; Appointments and Schedules ; Clinical Protocols ; Female ; General Practice ; Humans ; Intention to Treat Analysis ; Male ; Mental Disorders/diagnosis ; Mental Disorders/ethnology ; Mental Disorders/psychology ; Middle Aged ; Native Hawaiian or Other Pacific Islander/psychology ; New Zealand/epidemiology ; Office Visits ; Predictive Value of Tests ; Primary Health Care ; Psychiatric Status Rating Scales ; Research Design ; Syndrome ; Time Factors ; Treatment Outcome ; Young Adult

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.

Fam Pract. 2006 Feb;23(1):53-9. (PMID: 16303773)
Depress Anxiety. 2000;12(1):30-9. (PMID: 10999243)
Aust N Z J Psychiatry. 2005 Sep;39(9):772-81. (PMID: 16168035)
Psychol Med. 2007 Sep;37(9):1217-28. (PMID: 17306044)
Compr Psychiatry. 2006 Jan-Feb;47(1):35-41. (PMID: 16324900)
Fam Pract. 2013 Feb;30(1):76-87. (PMID: 22843638)
Psychol Med. 2006 Jan;36(1):3-6. (PMID: 16356291)
Acta Psychiatr Scand. 1983 Jun;67(6):361-70. (PMID: 6880820)
Psychiatr Clin North Am. 2002 Dec;25(4):685-98. (PMID: 12462855)
Aust N Z J Psychiatry. 1999 Feb;33(1):5-12. (PMID: 10197880)
Psychosom Med. 2007 Jan;69(1):30-9. (PMID: 17244846)
N Z Med J. 2003 Apr 04;116(1171):U379. (PMID: 12740629)
Psychol Med. 2002 Aug;32(6):959-76. (PMID: 12214795)
Br J Psychiatry. 2002 May;180:461-4. (PMID: 11983645)
J Biopharm Stat. 2009 Nov;19(6):1055-73. (PMID: 20183464)
Lancet. 2013 Nov 9;382(9904):1575-86. (PMID: 23993280)
Aust N Z J Public Health. 2001 Dec;25(6):494-7. (PMID: 11824981)
Psychol Med. 1997 Mar;27(2):363-70. (PMID: 9089829)
Aust N Z J Psychiatry. 2010 Apr;44(4):314-22. (PMID: 20307164)
Fam Pract. 2012 Feb;29(1):43-9. (PMID: 21885570)
BMJ. 2012 Sep 04;345:e5661. (PMID: 22951546)
J Prim Health Care. 2009 Mar;1(1):74-7. (PMID: 20690494)
Aust N Z J Psychiatry. 2005 May;39(5):401-6. (PMID: 15860029)
J Prim Health Care. 2012 Sep 01;4(3):231-8. (PMID: 22946072)
Lancet. 2012 Dec 15;380(9859):2053-4. (PMID: 23245595)
J Affect Disord. 1997 Aug;45(1-2):19-30. (PMID: 9268772)
Clin Trials. 2005;2(5):379-86. (PMID: 16315646)
Soc Psychiatry Psychiatr Epidemiol. 2005 Dec;40(12):994-1002. (PMID: 16258714)
Aust N Z J Psychiatry. 2006 Oct;40(10):889-95. (PMID: 16959015)
Psychol Med. 2004 Aug;34(6):959-71. (PMID: 15554567)
Psychol Med. 2000 Nov;30(6):1377-90. (PMID: 11097078)

ANZCTR ACTRN12613000041752

Date Created: 20150606 Date Completed: 20160225 Latest Revision: 20231111

20231215

PMC4472180

10.1186/s13063-015-0778-y

26044879