Association of Anxiety and Recurrent Cardiovascular Events: Investigating Different Aspects of Anxiety.

AIMS: While elevated levels of anxiety are associated with worse prognosis of cardiovascular disease (CVD), this association may vary between different aspects of anxiety. The aim of this study was to analyse self-reported behavioural, physiological, affective, and cognitive aspects of anxiety and their relation to the risk of recurrent CV events. METHODS AND RESULTS: This prospective cohort study utilized data from the U-CARE Heart trial. Participants (N = 935, post myocardial infarction) answered the Hospital Anxiety and Depression Scale (HADS: Anxiety subscale) and the Cardiac Anxiety Questionnaire (CAQ: Fear, Avoidance & Attention subscales). HADS Anxiety reflected physiological aspects, CAQ Fear reflected cognitive and affective aspects, CAQ Avoidance reflected behavioural aspects, and CAQ Attention reflected cognitive aspects of anxiety. Cox Regression was used to estimate the risk between anxiety and recurrent major adverse cardiac event (MACE). During the follow-up period (mean 2.9 years), 124 individuals (13%) experienced a specified MACE endpoint. HADS Anxiety and CAQ Total were both associated with increased risk of MACE (HR = 1.52, 95% CI: 1.15-2.02 and HR = 1.30, 95% CI: 1.04-1.64, respectively). Among the CAQ subscales, there was support for an association between Avoidance and risk of MACE (HR = 1.37, 95% CI 1.15-1.64), but not for Attention and Fear. CONCLUSION: The results support that anxiety is associated with an increased risk of recurrent MACE in post-MI patients. The association between anxiety and risk was strong for the aspects of anxiety relating to behaviour and physiology, while the support for an association with cognitive and affective aspects was lacking.

Randomized evaluation of routine beta-blocker therapy after myocardial infarction quality of life (RQoL): design and rationale of a multicentre, prospective, randomized, open, blinded endpoint study.

Aims: Most cases of acute myocardial infarction (MI) in Sweden are treated with long-term ß-blocker therapy as secondary prevention. Case studies and patient reports have indicated negative effects of ß-blockers including symptoms of depression, fatigue, sexual dysfunction, and general low mood, all related to reduced quality of life (QoL). To date, no recent large-scale, randomized trial has explored the effects of ß-blockers on these factors. Methods and results: The ongoing Randomized Evaluation of Decreased Usage of beta-bloCkErs after myocardial infarction (REDUCE): quality of life (RQoL) study is a multicentre, prospective, randomized pre-specified substudy aiming to evaluate the effects of ß-blockers on self-reported measures of QoL. Following randomized allocation to long-term ß-blocker or no ß-blocker treatment, patients complete a total of six baseline measures pertaining to QoL, sexual functioning, and perceived side effects. Data collection is optionally carried out online through a unique and secure portal and repeated again at two follow-up time points. Recruitment began in July 2018. Data from the first 100 patients showed that at the first follow-up, 93% had completed the questionnaires, which decreased to 81% at the second follow-up. The method of digital data collection was utilized by over half of the patients recruited so far. Conclusion: Data from the first 100 patients indicate success in terms of study design and recruitment. The RQoL substudy investigates the effects of ß-blockers on self-reported measures of QoL in MI patients and will potentially contribute to the limited knowledge of QoL-related side effects reported in conjunction with ß-blocker use. Clinical trial registration: Eudra CT number, 2017-002336-17; Clinical trial.gov identifier, NCT03278509.

Mobile health to promote physical activity in people post stroke or transient ischemic attack - study protocol for a feasibility randomised controlled trial.

BACKGROUND: Physical activity is essential to improve health and reduce the risk of recurrence of stroke or transient ischemic attack (TIA). Still, people post stroke or TIA are often physically inactive and the availability of physical activity promotion services are often limited. This study builds on an existing Australian telehealth-delivered programme (i-REBOUND- Let's get moving) which provides support for home-based physical activity for people post stroke or TIA. The aim of this study is to test the feasibility, acceptability, and preliminary effects of a mobile Health (mHealth) version of the i-REBOUND programme for the promotion of physical activity in people post stroke or TIA living in Sweden. METHODS: One hundred and twenty participants with stroke or TIA will be recruited via advertisement. A parallel-group feasibility randomised controlled trial design with a 1:1 allocation ratio to 1) i-REBOUND programme receiving physical exercise and support for sustained engagement in physical activity through behavioural change techniques, or 2) behavioural change techniques for physical activity. Both interventions will proceed for six months and be delivered digitally through a mobile app. The feasibility outcomes (i.e., reach, adherence, safety and fidelity) will be monitored throughout the study. Acceptability will be assessed using the Telehealth Usability Questionnaire and further explored through qualitative interviews with a subset of both study participants and the physiotherapists delivering the intervention. Clinical outcomes on preliminary effects of the intervention will include blood pressure, engagement in physical activity, self-perceived exercise self-efficacy, fatigue, depression, anxiety, stress and health-related quality of life and will be measured at baseline and at 3, 6 and 12 months after the baseline assessments. DISCUSSION: We hypothesise that the mHealth delivery of the i-REBOUND programme will be feasible and acceptable in people post stroke/TIA living in rural and urban regions of Sweden. The results of this feasibility trial will inform the development of full-scale and appropriately powered trial to test the effects and costs of mHealth delivered physical activity for people after stroke or TIA. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05111951. Registered November 8, 2021.

Management of emotional distress following a myocardial infarction: a qualitative content analysis.

Myocardial infarction (MI) is one of the leading causes of mortality and disability worldwide. Emotional distress, such as anxiety and depression, are common among MI patients. The aim of this study was to investigate emotional reactions following MI and to explore how MI patients self-manage their emotional distress using the perspective of an explanatory behavioural model of depression and anxiety. Written testimonies from 92 MI patients starting an internet-based cognitive behavioural therapy (iCBT) were analysed using qualitative content analysis with a mixed deductive and inductive approach. Six themes were identified. The first three highlight the emotional reactions post-MI: Hypoarousal reactions and low mood; Hyperarousal reactions; and A changed sense of self and outlook on life. The following three themes describe strategies for managing emotional distress: Avoidance of potentially rewarding situations; Avoidance of heart relevant stimuli triggering anxiety; and Engaging in potentially positive activities and acceptance. The MI experience may trigger emotional reactions, with a particular emphasis on heart-focused anxiety, depression and a shift in the perception of one's identity. Patients tend to manage emotional distress through social withdrawal and experiential avoidance which likely maintains the distress. Applying a behavioural model to the management of emotional distress following MI is suited.

Reducing stress and anxiety in patients with myocardial infarction with non-obstructive coronary arteries or Takotsubo syndrome: A non-randomized feasibility study.

Background and aim: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. The planned E-health Treatment of Stress and Anxiety in Stockholm Myocardial Infarction With Non-obstructive Coronaries Study (e-SMINC) aims to evaluate the effects of an internet-based intervention, building on cognitive behavioral therapy (CBT) by comparison with treatment as usual using an RCT approach. This was a small-scale single arm study designed to test the feasibility of the RCT, addressing uncertainties regarding recruitment, data collection, and intervention delivery. Methods: Participant recruitment and screening took place before discharge from the coronary care unit at a large Swedish hospital. Eligible patients were invited to a nine-step psychologist guided, internet-based CBT intervention. The sample size was set in advance to 10 participants completing the intervention. The recruitment and flow of participants were documented and evaluated in relation to seven pre-defined progression criteria. Self-reports of anxiety (HADS-A), stress (PSS-14), cardiac anxiety (CAQ), posttraumatic stress (IES-6) and quality of life (Rand-36), collected at screening, pre-intervention and post-intervention, were analysed descriptively and by effect sizes (Cohen's d). Individual interviews targeting participant experiences were conducted. Results: Six out of seven progression criteria yielded no concerns. Out of 49 patients with a working diagnosis of MINOCA or TS, 31 were eligible for screening, 26 consented to participate, and 14 were eligible with regard to symptoms of stress and/or anxiety. Eleven completed the pre-assessment and were given access the intervention, and 9 completed the intervention. Only the number of patients screened prior to eligibility assessment was slightly lower than expected, indicating possible concerns. Self-reports of anxiety, stress, cardiac anxiety, posttraumatic stress, and quality of life all indicated symptom reduction from pre- to post-intervention, generally showing large effect sizes (d = 0.6-2.6). The general consensus among participants was that the programme was helpful and relevant, and that the personal contact with the psychologist was highly valued. Setting aside time to complete assignments was found critical. Conclusion: Conducting a full scale RCT was found feasible. Inclusion of more study sites and minor amendments to the protocol and intervention were decided to improve feasibility further. Trial registration: Clinicaltrials.govNCT04178434.

The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial.

BACKGROUND: In the aftermath of a myocardial infarction with non-obstructive coronary arteries (MINOCA) or Takotsubo syndrome (TS), patients commonly express high levels of stress and anxiety. Current treatment alternatives rarely address these issues. METHODS: The study is a randomised controlled trial, where 90 patients with a discharge diagnosis of MINOCA or TS who also report symptoms of stress or anxiety will be randomised 2-6 weeks after their cardiac event. The treatment consists of 10 weeks of Internet-based cognitive behaviour therapy (CBT) and starts immediately after randomisation for the treatment group. The control group receives usual care. Main outcomes are symptoms of anxiety measured with the Hospital Anxiety and Depression scale, anxiety subscale, and perceived stress measured with the Perceived Stress Scale, 14-item version, 10 weeks after randomisation. Secondary measures include cardiac specific anxiety, symptoms of post-traumatic stress, quality of life, cortisol measured in hair and physiological stress responses (heart rate variability, blood pressure and saliva cortisol) during a stress procedure. Ten weeks after randomisation, the control group will also receive treatment. Long-term follow-up in the self-report measures mentioned above will be conducted 20 and 50 weeks after randomisation where the total group's development over time is followed, and the groups receiving intervention early versus late compared. DISCUSSION: At present, there are no randomised studies evaluating psychological treatment for patients with MINOCA or TS. There is an urgent need for treatment alternatives aiming at relieving stress and anxiety considering the high mental stress and anxiety levels observed in MINOCA and TS, leading to decreased quality of life. CBT aiming at reducing mental stress has been shown to be effective regarding prognosis in patients with coronary artery disease. The current protocol describes a randomised open-label controlled trial evaluating an Internet-based CBT program for reduction of stress and anxiety in patients with increased mental stress and/or anxiety with a discharge diagnosis of either MINOCA or TS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04178434 . Registered on 26 November 2019.

Association between ß-blocker dose and quality of life after myocardial infarction: a real-world Swedish register-linked study.

BACKGROUND: ß-blockers are routinely administered to patients following myocardial infarction (MI), yet their potential effect on health-related quality of life (HRQoL) is not entirely understood. We investigated the relationship between two different doses of ß-blockers with HRQoL following MI. METHODS AND RESULTS: This nationwide observational study used Swedish national registries to collate sociodemographic, clinical, medication, and HRQoL {the latter operationalized using EuroQol [European Quality of Life Five Dimensions Questionnaire (EQ-5D)]}. Estimates at 6-10 weeks and 12-14 months post-MI follow-up from pooled linear and logistic models were calculated after multiple imputation. We identified 35 612 patients with first-time MI, discharged with ß-blockers, and enrolled in cardiac rehabilitation between 2006 and 2015. Upon discharge, patients were either dispensed <50% [24 082 (67.6%)] or ≥50% [11 530 (32.4%)] of the target dosage, as defined in previous trials. After adjusting for pre-defined covariates, neither the EQ-5D Index nor the Emotional Distress items were statistically different between groups. The EQ-VAS score was significantly lower in patients treated with ≥50% target ß-blocker dose than those treated with <50% of the target dose [-0.87 [-1.23, -0.46], P < .001]. Results were similar at the 12-month follow-up and across sub-groups separated by sex and age. CONCLUSION: No difference in HRQoL was found among patients taking <50% vs. ≥50% of the target ß-blocker dose, except for the EQ-VAS in which higher scores were reported in those taking a lower dose. The clinical meaningfulness of this statistical significance is likely low.

Internet-Based Cognitive Behavioral Therapy for Patients Reporting Symptoms of Anxiety and Depression After Myocardial Infarction: U-CARE Heart Randomized Controlled Trial Twelve-Month Follow-up.

BACKGROUND: The U-CARE Heart trial was one of the first randomized controlled trials to evaluate the effect of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety or depression for patients with a recent myocardial infarction. While the effects of internet-based cognitive behavioral therapy on Hospital Anxiety and Depression Scale (HADS) scores at 14 weeks postbaseline were not significant, in this study, we investigated possible long-term effects of treatment. OBJECTIVE: The aim of this study was to evaluate the long-term effectiveness of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety and depression in patients 12 months after a myocardial infarction and to explore subsequent occurrences of cardiovascular disease events. METHODS: Shortly after acute myocardial infarction, 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 internet-based cognitive behavioral therapy (n=117) or treatment as usual (n=122). Data from national registries were used to explore group differences in clinical outcomes such as cardiovascular disease and cardiovascular-related mortality for a follow-up period of up to 5 years: group differences in HADS total score 1 year post-myocardial infarction, the primary outcome, was analyzed using multiple linear regression. Secondary outcomes, such as HADS anxiety and depression subscales and the Cardiac Anxiety Questionnaire total score (CAQ), which measures 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 (HRs) for data pertaining to registry outcomes. RESULTS: Both groups reported lower HADS total scores 1 year after myocardial infarction than those at baseline. HADS total scores were not significantly different between the treatment and control groups 1 year after myocardial infarction (ß=-1.14, 95% CI -2.73 to 0.45, P=.16). CAQ was the only measure improved significantly by internet-based cognitive behavioral therapy when compared with treatment as usual (ß=-2.58, 95% CI -4.75 to -0.42, P=.02) before adjusting for multiple comparisons. The composite outcome of nonfatal cardiovascular events and cardiovascular-related mortality did not differ between groups but was numerically higher in the internet-based cognitive behavioral therapy group, who were at slightly greater risk (HR 1.8, 95% CI 0.96 to 3.4, P=.07). Adjusting for previous myocardial infarction and diabetes attenuated this estimate (HR 1.5, 95% CI 0.8 to 2.8, P=.25). CONCLUSIONS: Internet-based cognitive behavioral therapy was not superior in reducing self-reported symptoms of depression or anxiety compared to treatment as usual at the 1-year follow-up after myocardial infarction. 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 affected treatment engagement and outcomes, should be considered when interpreting these results. TRIAL REGISTRATION: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-015-0689-y.

Association between ß-blocker dose and cardiovascular outcomes after myocardial infarction: insights from the SWEDEHEART registry.

AIMS: Dose-dependent effects of ß-blockers on survival and cardiovascular outcomes after myocardial infarction (MI) are not well understood. We investigated the long-term risk of cardiovascular events in patients with different doses of ß-blockers after MI. METHODS AND RESULTS: This was a nationwide observational study linking morbidity, mortality, socioeconomic, and medication data from Swedish national registries. Between 2006 and 2015, 97 575 unique patients with first-time MI were included. In total, 33 126 (33.9%) patients were discharged with ≥50% of the target ß-blocker dose and 64 449 (66.1%) patients with <50% of the target ß-blocker dose used in previous randomized trials. The primary composite endpoint was re-infarction or all-cause death within 1 year from discharge. Multivariable adjusted 1-year follow-up estimates using mixed effects Cox regression [HR (95% CI)] showed that patients treated with ≥50% of the target dose had a similar risk of the composite endpoint [1.03 (0.99-1.08)] and a somewhat higher risk when stroke, atrial fibrillation, or heart failure hospitalization were added to the composite endpoint [1.08 (1.04-1.12)], compared with patients on <50% of the target ß-blocker dose. Results remained similar up to 5 years of follow-up and consistent across relevant patient subgroups, including patients who developed heart failure during the index hospitalization. CONCLUSIONS: In contrast to doses of ß-blockers used in previous trials, ≥50% of the target ß-blocker dose was not associated with superior cardiovascular outcomes up to 5 years as compared with <50% of the target dose. Contemporary randomized clinical trials are needed to clarify the optimal dose of ß-blockers after MI.

Designing a Web-Based Psychological Intervention for Patients With Myocardial Infarction With Nonobstructive Coronary Arteries: User-Centered Design Approach.

BACKGROUND: The involvement of patient research partners (PRPs) in research aims to safeguard the needs of patient groups and produce new interventions that are developed based on patient input. Myocardial infarction with nonobstructive coronary arteries (MINOCA), unlike acute myocardial infarction (MI) with obstructive coronary arteries, is presented with no significant obstructive coronary artery disease. Patients with this diagnosis are a subset of those diagnosed with traditional MI and often need more psychological support, something that is presently not established in the current treatment scheme in Swedish health care or elsewhere, to our knowledge. An internet-delivered intervention might offer patients with MINOCA the opportunity to access a psychological treatment that is tailored to their specific needs after MINOCA and could therefore supplement the existing medical care in an easily accessible format. OBJECTIVE: This paper aims to describe the development of a therapist-guided, internet-delivered psychological intervention designed specifically for patients with MINOCA. METHODS: The study used a participatory design that involved 7 PRPs diagnosed with MINOCA who collaborated with a team consisting of researchers, cardiologists, and psychologists. Intervention content was developed iteratively and presented to the PRPs across several prototypes, each continually adjusted and redesigned according to the feedback received. The intervention and experience of it were discussed by PRPs in a final meeting and then presented to a panel of 2 clinical psychologists and a cardiologist for further input. RESULTS: The outcome of the collaboration between PRPs and the research group produced a web-based psychological 9-step program focusing on stress, worry, and valued action. The input from PRPs contributed substantially to the therapy content, homework tasks, interactive activities, multimedia, and design presentation. CONCLUSIONS: Working with PRPs to develop an intervention for people with MINOCA produced a web-based intervention that can be further evaluated with the goal of offering a new psychological treatment option to a patient group currently without one. Direct contribution from PRPs enabled us to obtain relevant, insightful, and valuable feedback that was put towards the overall design and content of the intervention.