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.

Identification of Anxiety and Depression Symptoms in Patients With Cancer: Comparison Between Short and Long Web-Based Questionnaires.

BACKGROUND: Physicians and nurses in cancer care easily fail to detect symptoms of psychological distress because of barriers such as lack of time, training on screening methods, and knowledge about how to diagnose anxiety and depression. National guidelines in several countries recommend routine screening for emotional distress in patients with cancer, but in many clinics, this is not implemented. By inventing screening methods that are time-efficient, such as digitalized and automatized screenings with short instruments, we can alleviate the burden on patients and staff. OBJECTIVE: The aim of this study was to compare Web-based versions of the ultrashort electronic Visual Analogue Scale (eVAS) anxiety and eVAS depression and the short Hospital Anxiety and Depression Scale (HADS) with Web-based versions of the longer Montgomery Åsberg Depression Rating Scale-Self-report (MADRS-S) and the State Trait Anxiety Inventory- State (STAI-S) with regard to their ability to identify symptoms of anxiety and depression in patients with cancer. METHODS: Data were obtained from a consecutive sample of patients with newly diagnosed (<6 months) breast, prostate, or colorectal cancer or with recurrence of colorectal cancer (N=558). The patients were recruited at 4 hospitals in Sweden between April 2013 and September 2015, as part of an intervention study administered via the internet. All questionnaires were completed on the Web at the baseline assessment in the intervention study. RESULTS: The ultrashort and short Web-based-delivered eVAS anxiety, eVAS depression and HADS were found to have an excellent ability to discriminate between persons with and without clinical levels of symptoms of anxiety and depression compared with recommended cutoffs of the longer instruments MADRS-S and STAI-S (area under the curve: 0.88-0.94). Cutoffs of >6 on HADS anxiety and >7 hundredths (hs) on eVAS anxiety identified patients with anxiety symptoms with high accuracy. For HADS depression, at a cutoff of >5 and eVAS depression at a cutoff of >7 hs, the accuracy was very high likewise. CONCLUSIONS: The use of the short and ultrashort tools, eVAS and HADS, may be a suitable initial method of Web-based screening in busy clinical settings. However, there are still a proportion of patients who lack access to the internet or the ability to use it. There is a need to find solutions for this group to find all the patients with psychological distress.

Predicting Adherence to Internet-Delivered Psychotherapy for Symptoms of Depression and Anxiety After Myocardial Infarction: Machine Learning Insights From the U-CARE Heart Randomized Controlled Trial.

BACKGROUND: Low 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. OBJECTIVES: The goal of the research was to use supervised machine learning to investigate both established and novel predictors for iCBT adherence in MI-ANXDEP patients. METHODS: Data 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. RESULTS: Patient 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. CONCLUSIONS: For 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 REGISTRATION: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22).

Treatment Activity, User Satisfaction, and Experienced Usability of Internet-Based Cognitive Behavioral Therapy for Adults With Depression and Anxiety After a Myocardial Infarction: Mixed-Methods Study.

BACKGROUND: Knowledge 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. OBJECTIVE: The 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. METHODS: This 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. RESULTS: Treatment 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. CONCLUSIONS: Patients 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 interventions in this population.

Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial.

BACKGROUND: Symptoms 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. OBJECTIVE: The 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. METHODS: In 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. RESULTS: There 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. CONCLUSIONS: iCBT 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 REGISTRATION: ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22).

Fifteen Challenges in Establishing a Multidisciplinary Research Program on eHealth Research in a University Setting: A Case Study.

BACKGROUND: U-CARE is a multidisciplinary eHealth research program that involves the disciplines of caring science, clinical psychology, health economics, information systems, and medical science. It was set up from scratch in a university setting in 2010, funded by a governmental initiative. While establishing the research program, many challenges were faced. Systematic documentation of experiences from establishing new research environments is scarce. OBJECTIVE: The aim of this paper was to describe the challenges of establishing a publicly funded multidisciplinary eHealth research environment. METHODS: Researchers involved in developing the research program U-CARE identified challenges in the formal documentation and by reflecting on their experience of developing the program. The authors discussed the content and organization of challenges into themes until consensus was reached. RESULTS: The authors identified 15 major challenges, some general to establishing a new research environment and some specific for multidisciplinary eHealth programs. The challenges were organized into 6 themes: Organization, Communication, Implementation, Legislation, Software development, and Multidisciplinarity. CONCLUSIONS: Several challenges were faced during the development of the program and several accomplishments were made. By sharing our experience, we hope to help other research groups embarking on a similar journey to be prepared for some of the challenges they are likely to face on their way.

Health-Related Internet Use in People With Cancer: Results From a Cross-Sectional Study in Two Outpatient Clinics in Sweden.

BACKGROUND: The access to various forms of support during the disease trajectory is crucial for people with cancer. The provision and use of Internet health services is increasing, and it is important to further investigate the preferences and demographical characteristics of its users. Investigating the uptake and perceived value of Internet health services is a prerequisite to be able to meet the needs in the targeted group. OBJECTIVE: The objective of this study was to investigate health-related Internet use among people with cancer. METHODS: The health online support questionnaire (HOSQ), examining the incentives for health-related Internet support use, was administered in two Swedish outpatient hospital clinics. Of the 350 copies of the questionnaire handed out, 285 (81.4%) were returned, answered by persons with cancer who had completed treatment or were under active surveillance or another medical treatment. RESULTS: A total of 215 (76.2%, 215/282) participants reported Internet use since being diagnosed with cancer. Internet-users were younger (P<.001), more likely to have a partner (P=.03), and had a higher level of education than nonusers (P<.001). The most common health-related activity on the Internet was searching for information (77.2%, 166/215), and users searched significantly more immediately after diagnosis compared with later on (P<.001). Use of My Healthcare Contacts was considered the most valuable Internet activity. Having a university degree (P ˂.001) and being younger in age (P=.01) were associated with a significantly higher frequency of health- related Internet use. CONCLUSIONS: People with cancer turn to the Internet for informational support that enables them to influence their care and to stay in touch with friends and relatives. Demographical differences regarding the uptake of Web-based support remains. This indicates a need for research on how to bridge this digital gap. By learning more about the use of health-related support on the Web among people with cancer, adequate support can be offered and potential strain reduced.

The Preference for Internet-Based Psychological Interventions by Individuals Without Past or Current Use of Mental Health Treatment Delivered Online: A Survey Study With Mixed-Methods Analysis.

BACKGROUND: The use of the Internet has the potential to increase access to evidence-based mental health services for a far-reaching population at a low cost. However, low take-up rates in routine care indicate that barriers for implementing Internet-based interventions have not yet been fully identified. OBJECTIVE: The aim of this study was to evaluate the preference for Internet-based psychological interventions as compared to treatment delivered face to face among individuals without past or current use of mental health treatment delivered online. A further aim was to investigate predictors of treatment preference and to complement the quantitative analyses with qualitative data about the perceived advantages and disadvantages of Internet-based interventions. METHODS: Two convenience samples were used. Sample 1 was recruited in an occupational setting (n=231) and Sample 2 consisted of individuals previously treated for cancer (n=208). Data were collected using a paper-and-pencil survey and analyzed using mixed methods. RESULTS: The preference for Internet-based psychological interventions was low in both Sample 1 (6.5%) and Sample 2 (2.6%). Most participants preferred psychological interventions delivered face to face. Use of the Internet to search for and read health-related information was a significant predictor of treatment preference in both Sample 1 (odds ratio [OR] 2.82, 95% CI 1.18-6.75) and Sample 2 (OR 3.52, 95% CI 1.33-9.29). Being born outside of Sweden was a significant predictor of preference for Internet-based interventions, but only in Sample 2 (OR 6.24, 95% CI 1.29-30.16). Similar advantages and disadvantages were mentioned in both samples. Perceived advantages of Internet-based interventions included flexibility regarding time and location, low effort, accessibility, anonymity, credibility, user empowerment, and improved communication between therapist and client. Perceived disadvantages included anonymity, low credibility, impoverished communication between therapist and client, fear of negative side effects, requirements of computer literacy, and concerns about confidentiality. CONCLUSIONS: Internet-based interventions were reported as the preferred choice by a minority of participants. The results suggest that Internet-based interventions have specific advantages that may facilitate help-seeking among some individuals and some disadvantages that may restrict its use. Initiatives to increase treatment acceptability may benefit from addressing the advantages and disadvantages reported in this study.

Measuring Use of Health-Related Support on the Internet: Development of the Health Online Support Questionnaire (HOSQ).

BACKGROUND: Social support plays an important role for the perceived health in people with health problems and chronic diseases. Provision of different kinds of support during the disease trajectory is crucial for many people. Online support is ubiquitous and represents a promising modality for people with chronic diseases. There are no existing instruments that measure various aspects of online support. OBJECTIVE: The objective of this study was to create a generic questionnaire regarding health-related support online that can be applied to people with various health problems and illnesses. Additionally, we wanted to test the questionnaire in a cancer population to assess its adequacy in the context of severe disease. METHODS: Initial items for the Health Online Support Questionnaire (HOSQ) were inspired by sociologist James House regarding social support. An exploratory factor analysis was conducted in healthy persons or with minor health problems (n=243) on 31 initial items. The scale was reduced to 18 items and the internal consistency and reliability of the scale was examined along with content validity. Further validation was conducted by a confirmatory analysis on the 18-item scale in a cancer population (n=215). In addition, data on demographics, health problems experienced, and Internet use were collected. RESULTS: The exploratory factor analysis on the final 18-item scale resulted in 2 factors. After scrutinizing the content, these factors were labeled "reading" and "interacting" and they demonstrated good internal consistency (Cronbach alphas .88 and .77, respectively). The factors were confirmed in the cancer population. The response pattern revealed expected differences both between the interaction and reading scales and according to age, gender, education, and health problems thereby supporting the validity of the HOSQ. CONCLUSIONS: The HOSQ may be a reliable and valid instrument for measuring the use of online support for people with health problems, but the results ought to be replicated in more studies to confirm the results for different diagnoses. If the results of this study are corroborated by future studies, the HOSQ may be used as a basis for the development of different forms of support on the Internet.