Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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

Published in: Trials | Issue 1/2015

Login to get access

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 ACTRN12613000041​752.
Literature
1.
2.
Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, et al. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study. Lancet. 2010;382:1575–86.CrossRef
3.
The World Health Organization. The global burden of disease: 2004 update. Geneva: World Health Organization; 2008.
4.
Oakley-Browne M, Wells J, Scott K. Te Rau Hinengaro: the New Zealand mental health survey summary. Wellington: Ministry of Health; 2006.
5.
Dowell A, Garrett S, Collings S, McBain L, McKinlay E, Stanley J. Evaluation of the Primary Mental Health Initiatives: summary report 2008. Wellington: Otago University Wellington and Ministry of Health; 2009.
6.
The MaGPIe Research group. The nature and prevalence of psychological problems in New Zealand primary health care: a report on Mental Health and General Practice Investigation. NZ Med J. 2003;116(1171):1–15.
7.
Judd L, Schettler P, Akiskal H. The prevalence, clinical relevance and public health significance of sub threshold depressions. Psychiatr Clin N Am. 2002;25:685–98.CrossRef
8.
Collings S, The MaGPIe Research Group. Disability and the detection of mental disorder in primary care. Soc Psychiatry Psychiatr Epidemiol. 2005;40:994–1002.CrossRefPubMed
9.
Backenstrass M, Frank A, Joest K, Hingman S, Mundt C, Kronmuller K. A comparative study of nonspecific depressive symptoms and minor depression regarding functional impairment and associated characteristics in primary care. Compr Psychiatry. 2006;47:35–41.CrossRefPubMed
10.
Wagner HR, Burns BJ, Broadhead WE, Yarnall KSH, Sigmon A, Gaynes BN. Minor depression in family practice: functional morbidity, co-morbidity, service utilisation and outcomes. Psychol Med. 2000;30:1377–90.CrossRefPubMed
11.
Kessler R, Zhao S, Blazer D, Swartz M. Prevalence, correlates, and course of minor depression in the national comorbidity survey. J Affect Disord. 1997;45(1–2):19–30.CrossRefPubMed
12.
Sadek N, Bona J. Subsyndromal symptomatic depression: a new concept. Depress Anxiety. 2000;12:30–9.CrossRefPubMed
13.
Mathieson F. Sub-threshold mental health syndromes: finding an alternative to the medication of unhappiness. J Prim Health Care. 2009;1(1):74–7.PubMed
14.
The MaGPIe Research Group. The treatment of common mental health problems in general practice. Fam Pract. 2006;23:53–9.CrossRef
15.
The MaGPIe Research Group. Mental disorders among Māori attending their general practitioners. Aust NZ J Psychiatry. 2005;39:401–6.CrossRef
16.
Jorm A, Griffiths K. Population promotion of informal self help strategies for early intervention against depression and anxiety. Psychol Med. 2006;36(1):3–6.CrossRefPubMed
17.
den Boer P, Wiersma D, van den Bosch R. Why is self-help neglected in the treatment of emotional disorders? Psychol Med. 2004;34:959–71.CrossRef
18.
Gellatly J, Bower P, Hennessy S, Richards D, Gilbody S, Lovell K. What makes self-help interventions effective in the management of depressive symptoms? Meta-analysis and meta-regression. Psychol Med. 2007;37(9):1217–28.CrossRefPubMed
19.
Collings S, Mathieson F, Dowell A, Stanley J, Jenkin G, Goodyear-Smith F, et al. Acceptability of a guided self-help mental health intervention in general practice. Fam Pract. 2012;29:43–9.CrossRefPubMed
20.
Fink P, Rosendal M, Olesen F. Classification of somatization and functional somatic symptoms in primary care. Aust NZ J Psychiatry. 2005;39:772–81.CrossRef
21.
Fink P, Toft T, Hansen MS, Ørnbøl E, Olsen F. Symptoms and syndromes of bodily distress: an exploratory study of 978 internal medical, neurological, and primary care patients. Psychosom Med. 2007;69:30–9.CrossRefPubMed
22.
Lam TP, Goldberg DP, Dowell AC, Fortes S, Mbatia JK, Minhas FA, et al. Proposed new diagnoses of anxious depression and bodily stress syndrome in ICD-11-PHC: an international focus group study. Fam Pract. 2012;30:76–87.CrossRefPubMed
23.
Mathieson F, Mihaere K, Collings S, Dowell A, Stanley J. Māori cultural adaptation of a brief mental health intervention in primary care. J Prim Health Care. 2012;4(3):231–8.PubMed
24.
Durie M. Mental health and Māori development. Aust NZ J Psychiatry. 1999;33(1):5–12.CrossRef
25.
Oakley Browne MA, Wells E, Scott KM, McGee MA. The Kessler Psychological Distress Scale in Te Rau Hinengaro: the New Zealand Mental Health Survey. Aust NZ J Psychiatry. 2010;44:314–22.CrossRef
26.
Kessler RC, Andrews G, Clope LJ, Hiripi E, Mroczek DK, Normand S-LT, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32:959–76.CrossRefPubMed
27.
Andrews G, Slade T. Interpreting scores on the Kessler Psychological Distress Scale (K10). Aust NZ J Public Health. 2001;25(6):494–7.CrossRef
28.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.CrossRefPubMed
29.
Mundt JC, Marks IM, Shear MK, Greist JH. The work and social adjustment scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRefPubMed
30.
Salmond C, Crampton P, Atkinson J. NZDep2006 index of deprivation. University of Otago, Wellington: Department of Public Health; 2007.
31.
Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997;27(2):363–70.CrossRefPubMed
32.
DeSouza CM, Legedza AT, Sankoh AJ. An overview of practical approaches for handling missing data in clinical trials. J Biopharm Stat. 2009;19(6):1055–73.CrossRefPubMed
33.
Beunckens C, Molenberghs G, Kenward MG. Direct likelihood analysis versus simple forms of imputation for missing data in randomized clinical trials. Clin Trials. 2005;2(5):379–86.CrossRefPubMed
34.
Campbell MK, Piaggio G, Elbourne DR, Altman DG. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.CrossRefPubMed
Metadata
Title
Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial
Authors
Sunny Collings
Fiona Mathieson
Anthony Dowell
James Stanley
Simon Hatcher
Felicity Goodyear-Smith
Brigitte Lane
Amy Munsterman
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0778-y

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial

Study protocol

Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial

Study protocol

The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials

Study protocol

Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Research

Who does not participate in telehealth trials and why? A cross-sectional survey

Study protocol

ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial