title: A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety.
abstract: OBJECTIVE
  Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety.
  
  
  METHODS
  The study consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1.
  
  
  RESULTS
  The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD-7 scores, 73.0 % had low probability of anxiety and 2.9 % had high anxiety. Higher anxiety levels were associated with recent (p = 0.017) and total number of shocks (p = 0.002). Any shock was associated with fear about shocks (FSAS, p < 0.001) and reduced patient ICD acceptance (FPAS, p = 0.019). In the pilot trial of CBT, median BAI scores decreased from 24.5 to 11 at 1 year (p = 0.031) in the CBT group and GAD-7 scores from 12.5 to 7 (p = 0.063); no significant changes in anxiety scores were observed in the UC group.
  
  
  CONCLUSIONS
  Severe anxiety was present in a small proportion of ICD patients, but higher anxiety was associated with recent and total number of shocks. The small pilot study suggested that a simple program of CBT might lower moderate-high anxiety with lasting effects to 1 year and supports the need for a larger trial to validate these results.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00851071. URL: http://clinicaltrials.gov/ct2/show/NCT00851071?term=anxiety+in+icd+patients+cleveland+clinic&rank=1.
authors.affiliation: Department of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Qintar
authors.forename: Jason J
authors.initials: JJ
authors.lastname: George
authors.forename: Melanie
authors.initials: M
authors.lastname: Panko
authors.forename: Scott
authors.initials: S
authors.lastname: Bea
authors.forename: Karen A
authors.initials: KA
authors.lastname: Broer
authors.forename: Julie
authors.initials: J
authors.lastname: St John
authors.forename: Kecia-Ann
authors.initials: KA
authors.lastname: Blissett
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Ching
authors.forename: Samuel F
authors.initials: SF
authors.lastname: Sears
authors.forename: Susanne S
authors.initials: SS
authors.lastname: Pedersen
authors.forename: Leopoldo
authors.initials: L
authors.lastname: Pozuelo
authors.forename: Mina K
authors.initials: MK
authors.lastname: Chung
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015928:Cognitive Behavioral Therapy / Q000379:methods; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000523:psychology; D006333:Heart Failure / Q000175:diagnosis / Q000517:prevention & control / Q000523:psychology; D010865:Pilot Projects; D011446:Prospective Studies; D013315:Stress, Psychological / Q000209:etiology / Q000523:psychology / Q000628:therapy; D016896:Treatment Outcome