Self-Management Training for Stress Reaction After ICD Shock
Trial Summary
What is the purpose of this trial?
This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an ICD delivered shock. The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe distress and post-traumatic stress disorder (PTSD), and ultimately promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial (N=60, 30/group). The purpose is to determine feasibility and potential effects of a self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered during the critical 1 month period after an ICD shock when distress is high. The intervention will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of PTSD is reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions are delivered at a crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed. The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to describe differential responses to the SPSM intervention. This study fills a significant gap in the care of patients with an ICD, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. Study findings will be used to design future larger RCTs to test intervention effectiveness for more diverse samples and settings.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the treatment Self-Paced Self-Management (SPSM) for stress reaction after ICD shock?
Research shows that self-management training can significantly reduce stress responses and improve well-being, as seen in a study where 322 patients experienced significant stress reduction, with improvements maintained at a 6-month follow-up. Additionally, self-management programs have been effective in managing chronic diseases by enhancing self-efficacy and promoting adaptive health behaviors.12345
Is self-management training generally safe for humans?
Self-management training, including techniques like biofeedback and stress management interventions, has been studied in various settings and is generally considered safe for humans. Research shows it can effectively reduce stress responses and improve health behaviors without significant safety concerns.36789
How is the Self-Paced Self-Management (SPSM) treatment different from other treatments for stress reactions after ICD shock?
The Self-Paced Self-Management (SPSM) treatment is unique because it focuses on empowering patients to actively manage their stress through self-regulation techniques, which can alter physiological processes, thoughts, behaviors, and emotions. Unlike other treatments, it emphasizes patient participation and self-efficacy (belief in one's ability to succeed) to maintain or improve stress management over time.2351011
Research Team
Cynthia M Dougherty, ARNP, PhD
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for adults with an implanted cardioverter-defibrillator (ICD) who've had a shock from it within the last week. They must have internet and phone access, speak English, and not have PTSD, schizophrenia, bipolar disorder, cognitive dysfunction or substance abuse issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the self-management intervention (SPSM) plus usual care or usual care alone, delivered over 1 month following an ICD shock
Follow-up
Participants are monitored for sustainability of intervention effects and reduction in PTSD incidence
Treatment Details
Interventions
- Self-Paced Self-Management (SPSM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
East Carolina University
Collaborator
National Institute of Nursing Research (NINR)
Collaborator