BackgroundSymptoms of depression and anxiety are common after a myocardial infarction (MI). Internet-based cognitive behavioral therapy (iCBT) has shown good results in other patient groups.ObjectiveThe aim of this study was to evaluate the effectiveness of an iCBT treatment to reduce self-reported symptoms of depression and anxiety among patients with a recent MI.MethodsIn total, 3928 patients were screened for eligibility in 25 Swedish hospitals. Of these, 239 patients (33.5%, 80/239 women, mean age 60 years) with a recent MI and symptoms of depression or anxiety were randomly allocated to a therapist-guided, 14-week iCBT treatment (n=117), or treatment as usual (TAU; n=122). The iCBT treatment was designed for post-MI patients. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) 14 weeks post baseline, assessed over the internet. Treatment effect was evaluated according to the intention-to-treat principle, with multiple imputations. For the main analysis, a pooled treatment effect was estimated, controlling for age, sex, and baseline HADS.ResultsThere was a reduction in HADS scores over time in the total study sample (mean delta=−5.1, P<.001) but no difference between the study groups at follow-up (beta=−0.47, 95% CI −1.95 to 1.00, P=.53). Treatment adherence was low. A total of 46.2% (54/117) of the iCBT group did not complete the introductory module.ConclusionsiCBT treatment for an MI population did not result in lower levels of symptoms of depression or anxiety compared with TAU. Low treatment adherence might have influenced the result.Trial RegistrationClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22)

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BackgroundLow adherence to recommended treatments is a multifactorial problem for patients in rehabilitation after myocardial infarction (MI). In a nationwide trial of internet-delivered cognitive behavior therapy (iCBT) for the high-risk subgroup of patients with MI also reporting symptoms of anxiety, depression, or both (MI-ANXDEP), adherence was low. Since low adherence to psychotherapy leads to a waste of therapeutic resources and risky treatment abortion in MI-ANXDEP patients, identifying early predictors for adherence is potentially valuable for effective targeted care.ObjectivesThe goal of the research was to use supervised machine learning to investigate both established and novel predictors for iCBT adherence in MI-ANXDEP patients.MethodsData were from 90 MI-ANXDEP patients recruited from 25 hospitals in Sweden and randomized to treatment in the iCBT trial Uppsala University Psychosocial Care Programme (U-CARE) Heart study. Time point of prediction was at completion of the first homework assignment. Adherence was defined as having completed more than 2 homework assignments within the 14-week treatment period. A supervised machine learning procedure was applied to identify the most potent predictors for adherence available at the first treatment session from a range of demographic, clinical, psychometric, and linguistic predictors. The internal binary classifier was a random forest model within a 3×10–fold cross-validated recursive feature elimination (RFE) resampling which selected the final predictor subset that best differentiated adherers versus nonadherers.ResultsPatient mean age was 58.4 years (SD 9.4), 62% (56/90) were men, and 48% (43/90) were adherent. Out of the 34 potential predictors for adherence, RFE selected an optimal subset of 56% (19/34; Accuracy 0.64, 95% CI 0.61-0.68, P<.001). The strongest predictors for adherence were, in order of importance, (1) self-assessed cardiac-related fear, (2) sex, and (3) the number of words the patient used to answer the first homework assignment.ConclusionsFor developing and testing effective iCBT interventions, investigating factors that predict adherence is important. Adherence to iCBT for MI-ANXDEP patients in the U-CARE Heart trial was best predicted by cardiac-related fear and sex, consistent with previous research, but also by novel linguistic predictors from written patient behavior which conceivably indicate verbal ability or therapeutic alliance. Future research should investigate potential causal mechanisms and seek to determine what underlying constructs the linguistic predictors tap into. Whether these findings replicate for other interventions outside of Sweden, in larger samples, and for patients with other conditions who are offered iCBT should also be investigated.Trial registrationClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22)

BackgroundEmotional distress, symptoms of depression and anxiety, is common among patients after a myocardial infarction (MI), and is associated with an increased risk of cardiovascular morbidity. Real world population data on factors associated with emotional distress in MI patients are scarce. The aim was to determine factors associated with incident emotional distress two and 12 months post MI respectively, and with persistent emotional distress, versus remittent, in patients <75 years old.DesignThis was a registry-based observational study.MethodsData from the national SWEDEHEART registry on 27,267 consecutive patients with a first-time MI, followed up at two and 12 months post MI (n = 22,911), were included in the analyses. Emotional distress was assessed with the EuroQol-5D questionnaire. Several candidate sociodemographic and clinical factors were analysed for their association with emotional distress in multivariate models.ResultsSymptoms of emotional distress were prevalent in 38% and 33% at two and 12 months post MI respectively. At both time-points, previous depression and/or anxiety, readmission for new cardiovascular event, female gender, younger age, born outside the neighbouring Nordic countries, smoking and being neither employed nor retired showed the strongest associations with emotional distress. Other factors related to medical history, the MI and its care or were only modestly associated with emotional distress. Persistent emotional distress was associated with younger age, female gender, smoking and being born outside of the Nordic countries.ConclusionPrevious depression/anxiety, female gender, younger age, smoking, born outside of the Nordic countries, neither employed nor retired and readmission due to cardiovascular events were strongly associated with emotional distress post MI. These factors may be of relevance in tailoring rehabilitation programmes.

Background Patients with symptoms of depression and/or anxiety – emotional distress – after a myocardial infarction (MI) have been shown to have worse prognosis and increased healthcare costs. However, whether specific subgroups of patients with emotional distress are more vulnerable is less well established. The purpose of this study was to identify the association between different patterns of emotional distress over time with late cardiovascular and non-cardiovascular mortality among first-MI patients aged <75 years in Sweden. Methods We utilized data on 57,602 consecutive patients with a first-time MI from the national SWEDEHEART registers. Emotional distress was assessed using the anxiety/depression dimension of the European Quality of Life Five Dimensions questionnaire two and 12 months after the MI, combined into persistent (emotional distress at both time-points), remittent (emotional distress at the first follow-up only), new (emotional distress at the second-follow up only) or no distress. Data on cardiovascular and non-cardiovascular mortality were obtained until the study end-time. We used multiple imputation to create complete datasets and adjusted Cox proportional hazards models to estimate hazard ratios. Results Patients with persistent emotional distress were more likely to die from cardiovascular (hazard ratio: 1.46, 95% confidence interval: 1.16, 1.84) and non-cardiovascular causes (hazard ratio: 1.54, 95% confidence interval: 1.30, 1.82) than those with no distress. Those with remittent emotional distress were not statistically significantly more likely to die from any cause than those without emotional distress. Discussion Among patients who survive 12 months, persistent, but not remittent, emotional distress was associated with increased cardiovascular and non-cardiovascular mortality. This indicates a need to identify subgroups of individuals with emotional distress who may benefit from further assessment and specific treatment.

BackgroundKnowledge about user experiences may lead to insights about how to improve treatment activity in Internet-based cognitive behavioral therapy (iCBT) to reduce symptoms of depression and anxiety among people with a somatic disease. There is a need for studies conducted alongside randomized trials, to explore treatment activity and user experiences related to such interventions, especially among people with older age who are recruited in routine care.ObjectiveThe aim of the study was to explore treatment activity, user satisfaction, and usability experiences among patients allocated to treatment in the U-CARE Heart study, a randomized clinical trial of an iCBT intervention for treatment of depression and anxiety following a recent myocardial infarction.MethodsThis was a mixed methods study where quantitative and qualitative approaches were used. Patients were recruited consecutively from 25 cardiac clinics in Sweden. The study included 117 patients allocated to 14 weeks of an iCBT intervention in the U-CARE Heart study. Quantitative data about treatment activity and therapist communication were collected through logged user patterns, which were analyzed with descriptive statistics. Qualitative data with regard to positive and negative experiences, and suggestions for improvements concerning the intervention, were collected through semistructured interviews with 21 patients in the treatment arm after follow-up. The interviews were analyzed with qualitative manifest content analysis.ResultsTreatment activity was low with regard to number of completed modules (mean 0.76, SD 0.93, range 0-5) and completed assignments (mean 3.09, SD 4.05, range 0-29). Most of the participants initiated the introduction module (113/117, 96.6%), and about half (63/117, 53.9%) of all participants completed the introductory module, but only 18 (15.4%, 18/117) continued to work with any of the remaining 10 modules, and each of the remaining modules was completed by 7 or less of the participants. On average, patients sent less than 2 internal messages to their therapist during the intervention (mean 1.42, SD 2.56, range 0-16). Interviews revealed different preferences with regard to the internet-based portal, the content of the treatment program, and the therapist communication. Aspects related to the personal situation and required skills included unpleasant emotions evoked by the intervention, lack of time, and technical difficulties.ConclusionsPatients with a recent myocardial infarction and symptoms of depression and anxiety showed low treatment activity in this guided iCBT intervention with regard to completed modules, completed assignments, and internal messages sent to their therapist. The findings call attention to the need for researchers to carefully consider the preferences, personal situation, and technical skills of the end users during the development of these interventions. The study indicates several challenges that need to be addressed to improve treatment activity, user satisfaction, and usability in internet-based ...

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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 (β=–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 (β=–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