A Randomized Controlled Trial of Secondary Prevention of Anxiety and Distress in a German Sample of Patients With an Implantable Cardioverter Defibrillator

Objective: To evaluate a minimal, easy, accessible intervention targeting anxiety and reduced quality of life in patients with an implantable cardioverter defibrillator (ICD). An estimated 24% to 87% of patients experience anxiety, and 10% to 15% have reduced quality of life. Methods: A total of 119 ICD patients were assigned randomly to usual medical aftercare (n = 63) or additional psychological treatment (n = 56) comprising of written information on medical and psychological consequences of an ICD plus 6 months of individual phone counseling. Treatment efficacy was evaluated by comparing T0 (immediately after implantation) and T1 (6 months later) assessments. Results: Although 75% of patients considered the program helpful, age moderated treatment efficacy. As indicated by triple interactions, only in the treatment group, anxiety (HADS-Anxiety, p < .01), psychological distress (SCL-K-9, p < .02), and somatic quality of life (SF-36-PCS, p < .01) improved in ICD patients aged <65 years but deteriorated in older patients (age, 65–75 years). Frequency of ICD discharges was associated with a symptom increase from T0 to T1 in all patients (HADS-Depression, CAQ-Avoidance, and ICD-Constraints; all p < .05). Conclusions: Our findings confirm that psychological treatments cannot be expected to have uniformly positive effects in ICD patients. Our minimal intervention may have adequately addressed ICD-related concerns in younger patients but may have fostered problems in older patients with fewer concerns. Therefore, our findings warrant custom treatment with particular attention to the elderly as well as patients with frequent ICD discharges. ANOVA = analysis of variance; ATP = antitachycardia pacing; BMI = body mass index; CAQ = Cardiac Anxiety Questionnaire; HADS = Hospital Anxiety and Depression Scale; ICD = implantable cardioverter defibrillator; MI = myocardial infarction; MANOVA = multivariate analysis of variance; QoL = quality of life; SCL-K-9 = Symptom Checklist, 9-item short form; SF-36-MCS = Medical Outcome Study Short Form-36 Health Survey: mental component summary; SF-36-PCS = Medical Outcome Study Short Form-36 Health Survey: physical component summary; T0 = assessment immediately after ICD implantation; T1 = assessment at the end of the intervention (i.e., 6 months later).