title: Cluster randomized controlled trial of a psycho-educational intervention for people with a family history of depression for use in general practice.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12613000402741).
authors.affiliation: Psychosocial Research Group, Prince of Wales Clinical School, The University of New Sourth Wales, Sydney, NSW 2052, Australia. b.meiser@unsw.edu.au.
authors.forename: Bettina
authors.initials: B
authors.lastname: Meiser
authors.forename: Peter R
authors.initials: PR
authors.lastname: Schofield
authors.forename: Lyndal
authors.initials: L
authors.lastname: Trevena
authors.forename: Alex
authors.initials: A
authors.lastname: Wilde
authors.forename: Kristine
authors.initials: K
authors.lastname: Barlow-Stewart
authors.forename: Judy
authors.initials: J
authors.lastname: Proudfoot
authors.forename: Michelle
authors.initials: M
authors.lastname: Peate
authors.forename: Timothy
authors.initials: T
authors.lastname: Dobbins
authors.forename: Helen
authors.initials: H
authors.lastname: Christensen
authors.forename: Kerry A
authors.initials: KA
authors.lastname: Sherman
authors.forename: Janan
authors.initials: J
authors.lastname: Karatas
authors.forename: Philip B
authors.initials: PB
authors.lastname: Mitchell
mesh_terms: D000328:Adult; D001315:Australia; D016000:Cluster Analysis; D003376:Counseling / Q000379:methods*; D003863:Depression / Q000517:prevention & control / Q000628:therapy*; D003866:Depressive Disorder / Q000517:prevention & control / Q000628:therapy*; D005192:Family Health; D005194:Family Practice / Q000458:organization & administration*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D011613:Psychotherapy / Q000379:methods*; D040242:Risk Reduction Behavior; D011795:Surveys and Questionnaires; D055815:Young Adult