title: Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD) A systematic review.
abstract: BACKGROUND
  Despite the potentially life-saving benefits of the implantable cardioverter-defibrillator (ICD), a significant group of patients experiences emotional distress after ICD implantation. Different psychosocial interventions have been employed to improve this condition, but previous reviews have suggested that methodological issues may limit the validity of such interventions.
  
  
  OBJECTIVE
  To review the methodology of previously published studies of psychosocial interventions in ICD patients, according to CONSORT statement guidelines for non-pharmacological interventions, and provide recommendations for future research.
  
  
  METHODS
  We electronically searched the PubMed, PsycInfo and Cochrane databases. To be included, studies needed to be published in a peer-reviewed journal between 1980 and 2008, to involve a human population aged 18+ years and to have an experimental design.
  
  
  RESULTS
  Twelve studies met the eligibility criteria. Samples were generally small. Interventions were very heterogeneous; most studies used cognitive behavioural therapy (CBT) and exercise programs either as unique interventions or as part of a multi-component program. Overall, studies showed a favourable effect on anxiety (6/9) and depression (4/8). CBT appeared to be the most effective intervention. There was no effect on the number of shocks and arrhythmic events, probably because studies were not powered to detect such an effect. Physical functioning improved in the three studies evaluating this outcome. Lack of information about the indication for ICD implantation (primary vs. secondary prevention), limited or no information regarding use of anti-arrhythmic (9/12) and psychotropic (10/12) treatment, lack of assessments of providers' treatment fidelity (12/12) and patients' adherence to the intervention (11/12) were the most common methodological limitations.
  
  
  CONCLUSIONS
  Overall, this review supports preliminary evidence of a positive effect of psychosocial interventions on anxiety and physical functioning in ICD patients. However, these initial findings must be interpreted cautiously because of important methodological limitations. Future studies should be designed as large RCTs, whose design takes into account the specific challenges associated with the evaluation of behavioural interventions.
authors.affiliation: University of Massachusetts Medical School, 55 Lake Ave Worcester, MA 01655-0002, USA. Elena.Salmoirago-Blotcher@umassmed.edu
authors.forename: Elena
authors.initials: E
authors.lastname: Salmoirago-Blotcher
authors.forename: Ira S
authors.initials: IS
authors.lastname: Ockene
mesh_terms: D001007:Anxiety / Q000517:prevention & control; D015928:Cognitive Behavioral Therapy; D017147:Defibrillators, Implantable / Q000523:psychology*; D003863:Depression / Q000517:prevention & control; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012064:Relaxation Therapy; D012657:Self-Help Groups; D013315:Stress, Psychological / Q000517:prevention & control*; D016896:Treatment Outcome