A mind-body resilience intervention for emotional distress in cardiac arrest survivors and their informal caregivers - Recovering together after cardiac arrest: Protocol for an open pilot trial.
Danielle La Camera, Jonathan Elmer, Sarah M Perman, Michael W Donnino, Ona Wu, Robert A Parker, Ana-Maria Vranceanu, Alexander M Presciutti
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引用次数: 0
Abstract
Background: Chronic emotional distress among cardiac arrest (CA) survivors and their caregivers is prevalent and worsens quality of life and recovery. Interventions to prevent chronic distress post-CA are needed. We developed Recovering Together after Cardiac Arrest (RT-CA), an intervention to increase resiliency in CA survivor-caregiver dyads (pairs).
Method: We will conduct an open pilot clinical trial of RT-CA to examine preliminary feasibility and refine the intervention based on participant feedback. We will enroll at least 7 CA survivor-caregiver dyads during their hospitalization at a single academic medical center. We will identify eligible survivors by screening admission reports and through referrals from medical staff. Inclusion criteria: Survivors - sufficient cognitive status to meaningfully participate (Short Form of the Mini Mental State Exam ≥5). Dyads - English-speakers; one member must have clinically significant distress (≥8 on either Hospital Anxiety and Depression Scale subscale). Procedure: dyads will participate in 6, 30-45 min sessions with a study clinician. Sessions will include mind-body coping skills training and provision of anticipatory guidance and resources to navigate CA-survivorship. Dyads will complete pre- and post-test measures of emotional distress and treatment targets. We will calculate frequencies and proportions of our primary outcomes (feasibility - recruitment, assessments, adherence, therapist fidelity and acceptability/credibility). After completing post-test assessments, dyads will provide feedback via exit interviews. We will integrate qualitative and quantitative data using explanatory-sequential mixed-methods.
Discussion: We will use our findings to refine RT-CA content and study procedures. If successful, RT-CA has potential to significantly improve quality of survivorship for CA survivors and their caregivers.
期刊介绍:
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.