Psychological outcomes following an online treatment component for anxiety and depression in patients with an implantable cardioverter defibrillator: secondary analysis of the ACQUIRE-ICD trial

Background About 20% of patients with an implantable cardioverter defibrillator (ICD) suffer from anxiety and/or depression. Yet, evidence is still scarce regarding the effectiveness of psychosocial interventions in this patient group. A web-based intervention to AdvanCe the QUalIty of life and caRE of patients with an ICD (ACQUIRE-ICD) was hence developed and tested as add-on to usual care in a national, non-blinded, parallel-group, randomised controlled trial, but there was no significant difference between the intervention and control group. Because the primary analyses included data from all participants, the effect in those with elevated anxiety and/or depression symptom-levels might have been obscured. Purpose This secondary analysis aims to investigate anxiety and depression outcomes in the participants who received the psychological treatment component as part of the ACQUIRE-ICD intervention. Methods 478 first-time ICD recipients were recruited from 2017 through 2020 from six implantation centres and randomly allocated to the intervention (n = 237) or control (n = 241) group. Measurements were completed at baseline and 6-, 12-, and 24-months post-implantation follow-up (FU), although participants’ mental and physical health were monitored monthly during the 1-year intervention period. The 7-week, web-based, psychological treatment component (see Figure 1) was offered exclusively if a participant scored 10 or higher on the Generalised Anxiety Disorder (GAD-7) and/or Patient Health Questionnaire (PHQ-9) at baseline or during monthly monitoring. Descriptive statistics (available case analyses) and one-way repeated measures analyses of variance (complete case analyses) were applied per-protocol to estimate the within-group effect of each outcome over time. Results 42 participants (17.7%) were referred to the psychological treatment component, of which 5 did not receive it as they were already receiving treatment (or planning to) outside of the study. 17 declined whilst 20 accepted, although 10 eventually dropped out. Adhering to the psychological treatment component (n = 8) had no statistically significant effect on anxiety (F[1.66, 11.61] = 2.98, p = .097, Greenhouse-Geisser η2p = .299) nor depression (F[1.27, 8.86] = 2.27, p = .166, Greenhouse-Geisser η2p = .245) outcomes over time. However, a reduction in symptoms was observed from baseline (M = 11.90, SD = 4.73 [GAD-7]; M = 13.40, SD = 6.24 [PHQ-9]) to 24-months FU (M = 8.63, SD = 7.09 [GAD-7]; M = 8.50, SD = 7.01 [PHQ-9]) (see Figure 2). Conclusion Despite the lack of statistical power, our findings suggest that web-based psychological treatment might improve anxiety and depression outcomes in adhering ICD patients, although some spontaneous remission is expected post-implantation. Future studies should investigate factors that influence treatment acceptance as well as adherence to accommodate all ICD patients who might benefit from psychological treatment.