Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 3, 2020
Date Accepted: Apr 26, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Twelve-Month Follow-up of the U-CARE Heart Randomized Controlled Trial: Internet-Based Cognitive Behavioral Therapy (iCBT) for Patients Reporting Symptoms of Anxiety and Depression after Myocardial Infarction
ABSTRACT
Background:
The U-CARE Heart trial was one of the first RCTs to evaluate the effect of internet-based cognitive behavioral therapy (iCBT) on self-reports of symptoms of anxiety and/or depression for patients with a recent myocardial infarction (MI). Whilst the effects on HADS-score of iCBT at 14 weeks post-treatment were not significant, the present study investigated possible long-term effects of treatment. Data from national registries was additionally used to explore group-differences in clinical outcomes such as cardiovascular disease (CVD) and cardiovascular-related mortality covering a follow-up time of up to five years.
Objective:
The aim of this study was to evaluate the long-term effectiveness of iCBT treatment on self-reported symptoms of anxiety and depression in patients 12 months after having an MI and to explore subsequent occurrences of CVD events.
Methods:
Shortly after an acute MI, 239 patients (33% female, mean age 59.6 years) reporting mild-to-moderate symptoms of anxiety or depression were randomized to 14-weeks of therapist-guided iCBT (n=117) or treatment as usual (TAU, n=122). Group differences 1-year post-MI in the Hospital Anxiety and Depression Scale (HADS) total score was the primary outcome analyzed using multiple linear regression. Secondary outcomes such as the HADS anxiety (HADS-A) and depression (HADS-D) subscales and the Cardiac Anxiety Questionnaire total score (CAQ) measuring heart-focused anxiety, were analyzed in the same way. Multiple imputation was used to account for missing data and a pooled treatment effect was estimated. Adjusted Cox proportional hazards models were used to estimate hazard ratios for data pertaining to registry outcomes.
Results:
Both groups reported lower HADS-T at 1-year post-MI follow-up compared to baseline. HADS-T scores were not significantly different between the treatment and control group one year after MI (beta= -1.14, 95% CI -2.73 to 0.45, P=0.16). Of the secondary measures, CAQ was the only measure that improved significantly in iCBT vs TAU (beta=-2.58, 95% CI -4.75 to -0.42, P=.02) before adjusting for multiple comparisons. The composite outcome of non-fatal cardiovascular events and cardiovascular-related mortality did not differ between groups, but was numerically higher in the iCBT group who were at slightly greater risk (HR = 1.8, 95% CI .96 to 3.4, P=.07). Adjusting for previous MI and diabetes attenuated this estimate (HR = 1.5, 95% CI 0.8 to 2.8, P= 0.25).
Conclusions:
iCBT was not superior in reducing self-reported symptoms of depression or anxiety compared to TAU at 1-year follow-up after MI. A reduction in cardiac-related anxiety was observed but was not significant after adjusting for multiple comparisons. There was no difference in risk of cardiovascular events between the treatment groups. Low treatment adherence, which might have effected treatment engagement and outcomes, should be considered when interpreting these results. Clinical Trial: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191
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