title: The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.
  
  
  METHODS
  This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.
  
  
  CONCLUSIONS
  The results of this study will constitute an important contribution to the body of knowledge of the respective interventions. Limitations are discussed.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01619930.
authors: Department of Psychology, Stockholm University, 10691, Stockholm, Sweden. per@carlbring.se
authors: Per
authors: P
authors: Carlbring
authors: Philip
authors: P
authors: Lindner
authors: Christopher
authors: C
authors: Martell
authors: Peter
authors: P
authors: Hassmén
authors: Lars
authors: L
authors: Forsberg
authors: Lars
authors: L
authors: Ström
authors: Gerhard
authors: G
authors: Andersson
mesh_terms: D001521:Behavior Therapy; D002985:Clinical Protocols; D003865:Major Depressive Disorder / Q000523:psychology / Q000628:therapy*; D015444:Exercise; D006801:Humans; D020407:Internet; D017063:Outcome Assessment, Health Care; D012008:Recurrence
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