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Mental health
Research
Cluster randomised controlled trial of a guided self-help mental health intervention in primary care
  1. Fiona Mathieson1,
  2. James Stanley2,3,
  3. Catherine (Sunny) Collings4,
  4. Rachel Tester5,
  5. Anthony Dowell6
  1. 1 Department of Psychological Medicine, University of Otago, Wellington, Wellington, New Zealand
  2. 2 Public Health, University of Otago, Wellington, Wellington, New Zealand
  3. 3 University of Otago, Wellington, Wellington, New Zealand
  4. 4 Deans Department, University of Otago, Wellington, Wellington, New Zealand
  5. 5 Primary Health Care and General Practice, University of Otago, Wellington, Wellington, New Zealand
  6. 6 General Practice, Wellington School of Medicine and Health Sciences, Wellington South, New Zealand
  1. Correspondence to Dr Fiona Mathieson; fiona.mathieson{at}otago.ac.nz

Abstract

Objectives To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns.

Trial design Two-arm cluster randomised controlled trial.

Methods Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18–65 years, scored ≤35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group).

Interventions: intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches.

Outcome measures: primary outcome was patient-level K10 score at 6 months postrecruitment.

Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.

Blinding: GPs were not blinded to group assignment.

Results Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).

Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed).

Outcome: K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI −1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups.

Conclusions: the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development.

Trial registration number ACTRN12613000041752; Pre-results.

  • mental health
  • primary care
  • briefIinterventions

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023481

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    Footnotes

    • Contributors All authors contributed to the study design and study protocol. FM and CSC are co-principal investigators. CSC conceived the study, obtained initial funding and contributed to the development of the intervention. FM and RT obtained co-funding. FM largely developed the intervention, led GP training and PHO liaison. AD contributed to the intervention design and GP training. JS contributed to the study design and designed and conducted the analysis. JS, FM, AD and CSC jointly interpreted the results. RT contributed as research assistant, assisted with practice recruitment and GP training, led the patient recruitment, data collection, processing and project management in the latter stages. All authors contributed to and approved the final manuscript.

    • Funding Funding for this study was received from the local partner PHO, Compass Health, The Oakley Mental Health Research Foundation, Wellington Medical Research Foundation and the University of Otago Research Fund. Funding was also received from the Health Research Council of New Zealand for the initial feasibility study, and from Oakley Mental Health Research Foundation and the University of Otago Research Fund for the Māori adaptation.

    • Disclaimer The funding bodies had no role in the study design, collection, analysis and interpretation of data or in the writing of the manuscript.

    • Competing interests None declared.

    • Ethics approval Ethical approval was received from the Health and Disability Ethics Committees, Ministry of Health (Northern B Health and Disability ethics committee 12/NTB/2).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Individual-level patient data are not available to other researchers as participants were not asked for consent to share their data. The study protocol (including statistical analysis plan) is available at (Collings et al, 2015) (DOI:10.1186/s13063-015-0778-y). The code used to conduct the statistical analysis is available from the second author on request (james.stanley@otago.ac.nz)

    • Patient consent for publication Not required.