title: Design paper: the DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression.
abstract: BACKGROUND
  In western countries, the yearly incidence of depression is estimated to be 3-5% and the lifetime prevalence is 17%. In patient populations with chronic diseases the point prevalence may be 20%. Depression is associated with increased risk for various conditions such as osteoporoses, cardiovascular diseases, and dementia. WHO stated in 2000 that depression was the fourth leading cause of disease burden in terms of disability. In 2000 the cost of depression in the US was estimated to 83 billion dollars. A predominance of trials suggests that physical exercise has a positive effect on depressive symptoms. However, a meta-analysis from 2001 stated: "The effectiveness of exercise in reducing symptoms of depression cannot be determined because of a lack of good quality research on clinical populations with adequate follow-up."
  
  
  OBJECTIVE
  The major objective for this randomized trial is to compare the effect of non-aerobic, aerobic, and relaxation training on depressive symptoms using the blindly assessed Hamilton depression scale (HAM-D(17)) as primary outcome. The secondary outcome is the effect of the intervention on working status (i.e., lost days from work, employed/unemployed) and the tertiary outcomes consist of biological responses.
  
  
  METHODS
  The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are recruited through general practitioners and psychiatrist and randomized to three different interventions: 1) non-aerobic, -- progressive resistance training, 2) aerobic training, -- cardio respiratory fitness, and 3) relaxation training with minimal impact on strength or cardio respiratory fitness. Training for all three groups takes place twice a week for 4 months. Evaluation of patients' symptoms takes place four and 12 months after inclusion. The trial is designed to include 45 patients in each group. Statistical analysis will be done as intention to treat (all randomized patients). Results from the DEMO trial will be reported according to the CONSORT guidelines in 2008-2009.
authors.affiliation: Psychiatric Department E, Bispebjerg Hospital, Copenhagen University Hospital,Copenhagen, Denmark. jk27@bbh.hosp.dk
authors.forename: Jesper
authors.initials: J
authors.lastname: Krogh
authors.forename: Lone
authors.initials: L
authors.lastname: Petersen
authors.forename: Michael
authors.initials: M
authors.lastname: Timmermann
authors.forename: Bengt
authors.initials: B
authors.lastname: Saltin
authors.forename: Merete
authors.initials: M
authors.lastname: Nordentoft
mesh_terms: D000293:Adolescent; D000328:Adult; D003863:Depression / Q000503:physiopathology* / Q000523:psychology / Q000628:therapy*; D015444:Exercise / Q000502:physiology* / Q000523:psychology*; D006801:Humans; D008875:Middle Aged; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods*; D012064:Relaxation Therapy; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome