title: Physical activity as a treatment for depression: the TREAD randomised trial protocol.
abstract: BACKGROUND
  Depression is one of the most common reasons for consulting a General Practitioner (GP) within the UK. Whilst antidepressants have been shown to be clinically effective, many patients and healthcare professionals would like to access other forms of treatment as an alternative or adjunct to drug therapy for depression. A recent systematic review presented some evidence that physical activity could offer one such option, although further investigation is needed to test its effectiveness within the context of the National Health Service.The aim of this paper is to describe the protocol for a randomised, controlled trial (RCT) designed to evaluate an intervention developed to increase physical activity as a treatment for depression within primary care.
  
  
  METHODS
  The TREAD study is a pragmatic, multi-centre, two-arm RCT which targets patients presenting with a new episode of depression. Patients were approached if they were aged 18-69, had recently consulted their GP for depression and, where appropriate, had been taking antidepressants for less than one month. Only those patients with a confirmed diagnosis of a depressive episode as assessed by the Clinical Interview Schedule-Revised (CIS-R), a Beck Depression Inventory (BDI) score of at least 14 and informed written consent were included in the study. Eligible patients were individually randomised to one of two treatment groups; usual GP care or usual GP care plus facilitated physical activity. The primary outcome of the trial is clinical symptoms of depression assessed using the BDI four months after randomisation. A number of secondary outcomes are also measured at the 4-, 8- and 12-month follow-up points including quality of life, attitude to and involvement in physical activity and antidepressant use/adherence. Outcomes will be analysed on an intention-to-treat (ITT) basis and will use linear and logistic regression models to compare treatments.
  
  
  CONCLUSIONS
  The results of the trial will provide information about the effectiveness of physical activity as a treatment for depression. Given the current prevalence of depression and its associated economic burden, it is hoped that TREAD will provide a timely contribution to the evidence on treatment options for patients, clinicians and policy-makers.
  
  
  BACKGROUND
  ISRCTN 16900744.
authors.affiliation: School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Grove, Bristol, BS8 2BN, UK. helen.baxter@bristol.ac.uk
authors.forename: Helen
authors.initials: H
authors.lastname: Baxter
authors.forename: Rachel
authors.initials: R
authors.lastname: Winder
authors.forename: Melanie
authors.initials: M
authors.lastname: Chalder
authors.forename: Christine
authors.initials: C
authors.lastname: Wright
authors.forename: Sofie
authors.initials: S
authors.lastname: Sherlock
authors.forename: Anne
authors.initials: A
authors.lastname: Haase
authors.forename: Nicola J
authors.initials: NJ
authors.lastname: Wiles
authors.forename: Alan A
authors.initials: AA
authors.lastname: Montgomery
authors.forename: Adrian H
authors.initials: AH
authors.lastname: Taylor
authors.forename: Ken R
authors.initials: KR
authors.lastname: Fox
authors.forename: Debbie A
authors.initials: DA
authors.lastname: Lawlor
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Peters
authors.forename: Deborah J
authors.initials: DJ
authors.lastname: Sharp
authors.forename: John
authors.initials: J
authors.lastname: Campbell
authors.forename: Glyn
authors.initials: G
authors.lastname: Lewis
mesh_terms: D003863:Depression / Q000628:therapy*; D015444:Exercise; D006801:Humans; D012107:Research Design; D018401:Sample Size