Open Access Study protocol

Cluster randomized controlled trial of a psycho-educational intervention for people with a family history of depression for use in general practice

Bettina Meiser1*, Peter R Schofield23, Lyndal Trevena4, Alex Wilde56, Kristine Barlow-Stewart4, Judy Proudfoot56, Michelle Peate1, Timothy Dobbins4, Helen Christensen6, Kerry A Sherman7, Janan Karatas8 and Philip B Mitchell56

Author Affiliations

1 Psychosocial Research Group, Prince of Wales Clinical School, The University of New Sourth Wales, Sydney, NSW 2052, Australia

2 Neuroscience Research Australia, Sydney, NSW 2031, Australia

3 School of Medical Sciences, University of New South Wales, Sydney, NSW 2052, Australia

4 Sydney School of Public Health, University of Sydney, Sydney, NSW 2006, Australia

5 School of Psychiatry, University of New South Wales, Sydney, NSW 2052, Australia

6 Black Dog Institute, Sydney, NSW 2031, Australia

7 Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, NSW 2109, Australia

8 Centre for Genetics Education, NSW Health, Royal North Shore Hospital, St Leonards, NSW 2065, Australia

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BMC Psychiatry 2013, 13:325  doi:10.1186/1471-244X-13-325

Published: 1 December 2013

Abstract

Background

The strongest risk factor for depression is having a family history of the condition. Many individuals with a family history of depression are concerned about their personal risk for depression and report unmet educational and psychological support needs. No supportive and/or educational interventions are currently available that target this group of individuals. In this study we will develop and evaluate the first online psycho-educational intervention targeted to individuals with a family history of depression. Genetic risk information and evidence-rated information on preventive strategies for depression will be provided to such individuals in a general practice setting. The intervention will also incorporate a risk assessment tool. The content and delivery of the intervention will be pilot-tested.

Methods/design

The proposed intervention will be evaluated in the general practitioner (GPs) setting, using a cluster randomized controlled trial. GP practices will be randomized to provide either access to the online, targeted psycho-educational intervention or brief generic information about depression (control) to eligible patients. Eligibility criteria include having at least one first-degree relative with either major depressive disorder (MDD) or bipolar disorder (BD). The primary outcome measure is 'intention to adopt, or actual adoption of, risk-reducing strategies’. Secondary outcome measures include: depression symptoms, perceived stigma of depression, knowledge of risk factors for development of depression and risk-reducing strategies, and perceived risk of developing depression or having a recurrence of family history. Over the course of the study, participants will complete online questionnaires at three time points: at baseline, and two weeks and six months after receiving the intervention or control condition.

Discussion

This novel psycho-educational intervention will provide individuals with a family history of depression with information on evidence-based strategies for the prevention of depression, thus, we hypothesize, enabling them to make appropriate lifestyle choices and implement behaviors designed to reduce their risk for depression. The online psycho-educational intervention will also provide a model for similar interventions aimed at individuals at increased familial risk for other psychiatric disorders.

Trial registration

The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12613000402741).

Keywords:
Family history; Major depressive disorder; Bipolar disorder; Online intervention; Psycho-education; Prevention