Methodological limitations of psychosocial interventions in patients with an implantable cardioverter-defibrillator (ICD) A systematic review
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Published on: February 28, 2012
Elena Salmoirago-Blotcher1, Ira S Ockene
1University of Massachusetts Medical School, 55 Lake Ave Worcester, MA 01655-0002, USA. Elena.Salmoirago-Blotcher@umassmed.edu
Insights
Psychosocial interventions show promise for improving anxiety and physical functioning in implantable cardioverter-defibrillator (ICD) patients. However, methodological limitations necessitate cautious interpretation and larger, well-designed future studies.
Area of Science:
- Cardiology
- Psychology
- Health Services Research
Background:
- Implantable cardioverter-defibrillators (ICDs) save lives but can cause emotional distress in patients.
- Existing psychosocial interventions aim to mitigate this distress, but their effectiveness is questioned due to methodological flaws.
Purpose of the Study:
- To critically evaluate the methodology of psychosocial intervention studies in ICD patients.
- To provide recommendations for future research based on CONSORT guidelines for non-pharmacological interventions.
Main Methods:
- Systematic electronic search of PubMed, PsycInfo, and Cochrane databases (1980-2008).
- Inclusion of peer-reviewed experimental studies involving adult populations.
Main Results:
- Twelve studies were included, featuring small sample sizes and heterogeneous interventions (e.g., cognitive behavioral therapy, exercise).
- Positive effects were observed for anxiety and depression, with cognitive behavioral therapy being most effective.
- No significant impact on shocks or arrhythmic events was detected; physical functioning improved in evaluated studies.
- Common limitations included lack of detail on ICD indication, concomitant medications, treatment fidelity, and patient adherence.
Conclusions:
- Preliminary evidence suggests psychosocial interventions can benefit anxiety and physical functioning in ICD patients.
- Methodological limitations require cautious interpretation of current findings.
- Future research should prioritize large randomized controlled trials (RCTs) addressing the complexities of behavioral intervention evaluation.
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.
Aim:
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.
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