Trial Summary
What is the purpose of this trial?The eMotion intervention, developed by the PI, provides training on multiple emotion regulation skills based on leading theories and evidence-based emotion regulation interventions. After initial pilot testing of eMotion, the investigators revised the intervention to make it more relevant to women from diverse backgrounds, as these women are disproportionately impacted by social determinants of health that complicate their recovery. It is important to revise the intervention to be acceptable to women from diverse backgrounds and to address their unique needs. The investigators want to explore if women from diverse backgrounds find the revised intervention relevant, meaningful, and easy to understand and apply to their lives. Their feedback will help investigators further revise the intervention to make it acceptable for this population.
Is the treatment eMotion a promising treatment for emotional well-being?Yes, eMotion is a promising treatment for emotional well-being. It helps people understand and manage their emotions better, which is linked to improved well-being. By focusing on how we react to daily events and emotions, eMotion can enhance our emotional health and overall happiness.29101115
What data supports the idea that eMotion for Emotional Well-being is an effective treatment?The available research does not provide specific data on the effectiveness of eMotion for Emotional Well-being. Instead, it discusses the importance of patient-reported outcomes and satisfaction in understanding treatment effectiveness. These outcomes are crucial for evaluating how well a treatment works, but no direct evidence about eMotion's effectiveness is mentioned.156812
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for the eMotion treatment?The provided research does not contain specific safety data for the eMotion treatment or any treatment evaluated under different names, including eMotion. The articles focus on adverse events in healthcare settings, patient-reported outcomes, and support for healthcare workers, but do not mention eMotion or related treatments.3471314
Eligibility Criteria
This trial is for women living independently with mild symptoms of depression or anxiety, as measured by specific questionnaires. They must have experienced their first major cardiac event. The study aims to help those particularly affected by social factors that influence health recovery.Inclusion Criteria
I have mild depression or anxiety based on PHQ-8 or GAD-7 scores.
Treatment Details
The eMotion intervention is being tested for its relevance and effectiveness in helping women from diverse backgrounds manage emotions after a cardiovascular event. It's based on evidence-based emotion regulation skills tailored to meet unique needs.
1Treatment groups
Experimental Treatment
Group I: eMotion InterventionExperimental Treatment1 Intervention
This is a single-group study assessing participation satisfaction with the 10-week eMotion intervention. The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for adults following a first cardiac event.
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Research locations nearbySelect from list below to view details:
Eskenazi HospitalIndianapolis, IN
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
References
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Emotional states and physical health. [2022]Positive emotional states may promote healthy perceptions, beliefs, and physical well-being itself. To explore potential mechanisms linking pleasant feelings and good health, the authors consider several lines of research, including (a) direct effects of positive affect on physiology, especially the immune system, (b) the information value of emotional experiences, (c) the psychological resources engendered by positive feeling states, (d) the ways in which mood can motivate health-relevant behaviors, and (e) the elicitation of social support. As anticipated by the Greek physician Hippocrates, positive emotions and healthy outcomes may be linked through multiple pathways.
Adverse events in New Zealand public hospitals I: occurrence and impact. [2022]To assess the occurrence and impact of adverse events in New Zealand public hospitals.
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Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. [2022]While clinical care is frequently directed at making patients "feel better," patients' reports on their functioning and well-being (patient-reported outcomes [PROs]) are rarely collected in routine clinical practice. The International Society for Quality of Life Research (ISOQOL) has developed a User's Guide for Implementing Patient-Reported Outcomes Assessment in Clinical Practice. This paper summarizes the key issues from the User's Guide.
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Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. [2022]The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-risk assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and risk assessment processes remain heavily dependent on healthcare professionals, though there are known limitations such as under-reporting and discordant perspectives between patient reports and clinician perceptions of adverse outcomes. PROSPER seeks to support the wider use of PRO-AEs. The scope of this guidance document, which was completed between July 2011 and March 2013, considered a host of domains related to PRO-AEs, including definitions and suitable taxonomies, the range of datasets that could be used, data collection mechanisms, and suitable analytical methodologies. PROSPER offers an innovative framework to differentiate patient populations. This framework considers populations that are prespecified (such as those in clinical trials, prospective observational studies and some registries) and non-prespecified populations (such as those in claims databases, PRO-enabled online patient networks, and social websites in general). While the main focus of this guidance is on post-approval PRO-AEs from both prespecified and non-prespecified population groups, PROSPER has also considered pre-approval, prespecified populations. The ultimate aim of this guidance is to ensure that the patient 'voice' and perspective feed appropriately into collection of safety data. The guidance also covers a minimum core dataset for use by industry or regulators to structure PRO-AEs (accessible in the online appendix) and how data, once collected, might be evaluated to better inform on the safe and effective use of medicinal products. Structured collection of such patient data can be considered both a means to an end (improving patient safety) as well as an end in itself (expressing the patient viewpoint). The members of the PROSPER Consortium therefore direct this PRO-AE guidance to multiple stakeholders in drug safety, including industry, regulators, prescribers and patients. The use of this document across the entirety of the drug development life cycle will help to better define the benefit-risk profile of new and existing medicines. Because of the clinical relevance of 'real-world' data, PROs have the potential to contribute important new knowledge about the benefits and risks of medicinal products, communicated through the voice of the patient.
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Higher well-being is related to reduced affective reactivity to positive events in daily life. [2020]Within the study of emotions, researchers have increasingly stressed the importance of studying individual differences in emotion dynamics and emotional responding and the way these relate to more stable differences in well-being. However, there is no clear picture regarding affective reactivity to positive events and how different emotional reactions relate to differences in well-being, particularly higher levels of well-being. Theoretical work and empirical findings from different lines of research (e.g., clinical studies, aging literature, positive and personality psychology) support either of 2 predictions: Higher well-being is related to an enhanced or reduced affective reactivity to positive events in daily life. Testing these opposing predictions, we examined global well-being and affective reactivity to daily positive events in 6 studies using the experience-sampling or daily diary method (Ns = 70, 66, 95, 200, 76, and 101). Global well-being was measured with various indicators and a well-being composite score. Across the majority of studies, we found that higher global well-being was associated with reduced affective reactivity to positive events in daily life, as shown by smaller decreases in momentary negative affect. In 3 of the 6 studies, higher well-being composite scores were also associated with smaller increases in momentary positive affect. These findings seem to suggest that people with higher global well-being profit less from the joy of a positive event they experience in daily life. Instead, for people with lower well-being, positive events might be a meaningful way to brighten one's momentary mood. (PsycInfo Database Record (c) 2020 APA, all rights reserved).
The Influence of Daily Events on Emotion Regulation and Well-Being in Daily Life. [2022]We examined within-person relationships among daily events, emotion regulation strategies, and well-being in daily life. Each day for 2 to 3 weeks, participants in two studies (total N = 445) reported the extent to which they reappraised and suppressed their positive and negative emotions, the types of events they experienced, and their well-being. Using multilevel modeling, we found that the extent to which people reappraised positive and negative emotions and suppressed negative emotions was positively related to the number/importance of daily positive events, whereas the suppression of positive emotions was negatively related. Furthermore, the positive relationships between well-being and reappraisal of positive and negative emotions and the suppression of negative emotions were stronger as the number of negative events increased. These results demonstrate that most emotion regulation strategies are employed when the day is going well but are most beneficial for people's well-being when the day is not going well.
Measuring What Matters: Patient-Reported Outcome and Experience Measures for Men Undergoing Radical Prostatectomy. [2022]Patient-reported outcome and experience measures capture a reliable representation of a patient's functional outcomes and quality of life. However, they are only helpful if the data are easily comprehensible to patients and are accessible to providers, patients, and payers. If we want to ensure that these metrics are fair, accurate, and relevant, then physicians should be leaders in developing and adopting these tools.
The psychological impact of adverse events on urology trainees. [2023]Adverse events (AE) are an inevitable reality in healthcare, with an incidence of 7.5-14.1% worldwide. AEs are recognised to cause psychological and emotional distress in healthcare workers, with surgeons being particularly susceptible. We report the first data on the emotional impact in relation to adverse events in surgeons in the Republic of Ireland (ROI).
Second Victim Support at the Core of Severe Adverse Event Investigation. [2023]There is limited evidence and a lack of standard operating procedures to address the impact of serious adverse events (SAE) on healthcare workers. We aimed to share two years' experience of a second victim support intervention integrated into the SAE management program conducted in a 500-bed University Hospital in Granada, Spain. The intervention strategy, based on the "forYOU" model, was structured into three levels of support according to the degree of affliction and the emotional needs of the professionals. A semi-structured survey of all workers involved in an SAE was used to identify potential second victims. Between 2020 and 2021, the SAE operating procedure was activated 23 times. All healthcare workers involved in an SAE (n = 135) received second-level support. The majority were physicians (51.2%), followed by nurses (26.7%). Only 58 (43.0%) received first-level emotional support and 47 (34.8%) met "second victim" criteria. Seven workers (14.9%) required third-level support. A progressive increase in the notification rates was observed. Acceptance of the procedure by professionals and managers was high. This novel approach improved the number of workers reached by the trained staff; promoted the visibility of actions taken during SAE management and helped foster patient safety culture in our setting.
Understanding and Taking Stock of Positive Emotion Disturbance. [2023]The prevailing view on positive emotions is that they correlate with and confer psychological health benefits for the individual, including improved social, physical and cognitive functioning. Yet an emerging wave of scientific work suggests that positive emotions are also related to a range of suboptimal psychological health outcomes, especially when the intensity, duration, or context do not optimize the individual's goals or meet current environmental demands. This paper provides an overview of the 'other side' of positive emotion, by describing and reviewing evidence supporting the emerging field of Positive Emotion Disturbance (PED). We review relevant emotion processes and key themes of PED and apply this framework to example emotional disorders, and discuss implications for psychological change and future research agendas.