title: Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI.
  
  
  METHODS
  This is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment.
  
  
  CONCLUSIONS
  The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care.
  
  
  BACKGROUND
  This trial was registered with Clinicaltrials.gov (identifier: NCT01504191 ) on 19 December 2011.
authors: Department of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. fredrika.norlund@pubcare.uu.se.
authors: Fredrika
authors: F
authors: Norlund
authors: Department of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. erik.olsson@pubcare.uu.se.
authors: Erik M G
authors: EM
authors: Olsson
authors: Department of Public Health and Caring Sciences, Uppsala University, Box 564, Uppsala, SE-751 22, Sweden. gunilla.burell@pubcare.uu.se.
authors: Gunilla
authors: G
authors: Burell
authors: Department of Psychology, Uppsala University, Box 562 S-75122, Uppsala, Sweden. emma.wallin@psyk.uu.se.
authors: Emma
authors: E
authors: Wallin
authors: Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center Uppsala University, Dag Hammarskjölds väg 14B, S-752 37, Uppsala, Sweden. claes.held@ucr.uu.se.
authors: Claes
authors: C
authors: Held
mesh_terms: D000368:Aged; D001007:Anxiety / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003863:Depression / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000523:psychology*; D011446:Prospective Studies; D012107:Research Design; D057566:Self Report; D013548:Sweden; D017216:Telemedicine / Q000379:methods*; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome