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.

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.

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.