Self-Management Training for Stress Reaction After ICD Shock

Overseen By Cynthia M Dougherty, ARNP, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: PTSD, Schizophrenia, Bipolar, Cognitive dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a self-management program designed to help individuals who have experienced a shock from their implantable cardioverter defibrillator (ICD) feel less anxious and resume daily activities. The program, called Self-Paced Self-Management (SPSM), combines heart rate self-monitoring with online learning modules. Researchers aim to determine if this approach, alongside usual care, is more effective than usual care alone in reducing anxiety and preventing post-traumatic stress disorder (PTSD) symptoms. Individuals who have received at least one ICD shock and have internet access may be suitable candidates for this study. The goal is to improve the quality of life for ICD patients and discover better ways to support them in the future. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for ICD patients.

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 prior data suggests that this self-management intervention is safe for patients after an ICD shock?

Studies have shown that self-paced self-management (SPSM) systems, like the one used in this trial, are generally safe. These systems help people track their heart rate and manage stress through online lessons. The program does not involve new medicines or medical procedures, so the risk of serious side effects remains low.

In similar research, participants using SPSM reported few problems. Most issues were minor, such as technical glitches with the online lessons, rather than health concerns. Since this trial tests an online program to manage stress after an ICD shock, safety concerns are minimal. The focus is on teaching skills and providing support, which participants generally handle well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Self-Paced Self-Management (SPSM) intervention because it empowers patients to manage stress after an ICD shock through heart rate self-monitoring and online shock management modules. Unlike the usual care, which involves standard observation and post-ICD shock care at clinics, SPSM offers a proactive, patient-centered approach. This method not only provides a unique opportunity for patients to actively engage in their recovery but also has the potential to improve outcomes by addressing stress through self-management techniques.

What evidence suggests that this self-management intervention is effective for reducing stress after an ICD shock?

Research shows that self-paced self-management (SPSM), which participants in this trial may receive, can help lower anxiety and improve daily life after a shock from an ICD (implantable cardioverter-defibrillator). Studies have found that learning to monitor heart rate and using online learning tools can help patients manage stress better. This method aims to prevent severe distress and symptoms of PTSD, improving the overall quality of life for those affected. Early results suggest that SPSM is promising in helping people return to normal activities more quickly after an ICD shock. These interventions occur immediately after the shock, when stress levels are high, and may help reduce long-term anxiety and depression. ^{1 3 4 5 6}

Who Is on the Research Team?

Cynthia M Dougherty, ARNP, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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

Able to read, speak and write English

Access to online resources and telephone for study duration

I have received at least one shock from my ICD in the last week.

Exclusion Criteria

You use illegal drugs on a regular basis for non-medical reasons.

Your AUDIT-C score is 4 or higher, indicating significant alcohol use.

You have a high BLESSED score, which means you have trouble with your memory and thinking abilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 days

Treatment

Participants receive the self-management intervention (SPSM) plus usual care or usual care alone, delivered over 1 month following an ICD shock

4 weeks

4 self-paced, web-based modules

Follow-up

Participants are monitored for sustainability of intervention effects and reduction in PTSD incidence

6 months

Periodic assessments at 1 and 6 months post-shock

What Are the Treatments Tested in This Trial?

Interventions

• Self-Paced Self-Management (SPSM)

Trial Overview The study tests a self-management program delivered online to reduce anxiety and prevent PTSD after an ICD shock. It compares this program plus usual care against usual care alone over one month with follow-up at six months to check long-term effects.

How Is the Trial Designed?

Group I: SPSM intervention Experimental Treatment 1 Intervention

Heart rate self monitoring Online shock management modules

Group II: usual care Active Control 1 Intervention

standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

East Carolina University

Collaborator

Trials

111

Recruited

42,400+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

An individualized stress management training program using biofeedback was shown to improve employee performance, health behaviors, and cognitive functions, demonstrating its efficacy in a workplace setting.

The program yielded a significant cost-benefit ratio, with a return of $5.52 for every dollar invested, highlighting its financial viability and effectiveness in enhancing employee well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Equitable Life Assurance Society program. Manuso, JS.[2019]

A study involving 213 participants in a telehealth chronic disease self-management program found that social identification with group members positively influenced both group-derived efficacy and individual self-efficacy, leading to improved health outcomes.

The findings suggest that enhancing group identification in self-management programs can further boost participants' confidence and overall mental and physical health, highlighting the importance of social support in managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In this together": Social identification predicts health outcomes (via self-efficacy) in a chronic disease self-management program. Cameron, JE., Voth, J., Jaglal, SB., et al.[2019]

In a study of 35 borderline hypertensive males undergoing a self-management program, those with treatment-resistant hypertension exhibited significantly higher levels of psychological distress and life changes compared to those whose hypertension was controlled.

The findings suggest that psychological status may play a crucial role in the effectiveness of hypertension treatments, indicating that addressing psychological factors could improve treatment outcomes for individuals with high blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of psychological distress on the control of hypertension. Egan, KJ., Kogan, HN., Garber, A., et al.[2009]

A structured self-management program for patients with implantable cardioverter defibrillators (ICDs) was found to be feasible and well-received, with 80% of participants attending at least four out of six sessions and reporting high satisfaction (average score of 8.4).

Participants showed significant improvements in self-efficacy, anxiety symptoms, and various aspects of quality of life, including physical and social functioning, suggesting that such programs could be beneficial for ICD patients adjusting to their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse- and peer-led self-management programme for patients with an implantable cardioverter defibrillator; a feasibility study. Smeulders, ES., van Haastregt, JC., Dijkman-Domanska, BK., et al.[2020]

Multimodal biopsychosocial training programs, which include techniques like mindfulness and cognitive behavioral stress management, can effectively reduce stress-related symptoms in combat-exposed troops and their families.

The systematic review highlights the feasibility of implementing these self-management techniques within military training cycles, suggesting they can help preempt or lessen posttraumatic stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of biopsychosocial training programs for the self-management of emotional stress: potential applications for the military. Crawford, C., Wallerstedt, DB., Khorsan, R., et al.[2021]

Self-management training significantly reduces stress responses in patients, with a study of 322 participants showing highly significant changes (P = .0001).

At a 6-month follow-up, 182 patients maintained or improved their status (P = .001), while a comparison group showed no improvement, highlighting the effectiveness of this nursing intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management: a nursing mode of therapeutic influence. Kogan, HN., Betrus, PA.[2010]

Cognitive behavioral stress management training significantly reduced work-related anxiety in inexperienced nurses, indicating its efficacy in helping them cope with stress.

The improvement in anxiety levels among inexperienced nurses was linked more to their increased understanding of stress and feelings of control rather than changes in their actual stress management behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of stress management training for nurses working in a burn treatment unit. von Baeyer, C., Krause, L.[2019]

Cardiovascular biofeedback did not significantly reduce self-reported stress levels among nursing staff compared to a control activity, but it did show changes in heart rate variability, indicating potential physiological benefits.

The study involved 115 nursing professionals over nine sessions in three weeks, suggesting that while self-reported stress measures were unaffected, cardiovascular biofeedback may help improve autonomic nervous system regulation, making it a promising complementary therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cardiovascular biofeedback on nursing staff stress: a randomized controlled clinical trial. Macedo, ABT., Vega, EAU., Antoniolli, L., et al.[2023]

Self-management is an effective approach for managing chronic conditions, involving tasks like medical management, role management, and emotional management, along with skills such as problem solving and decision making.

The success of self-management interventions is linked to self-efficacy, suggesting that empowering patients to take control of their health can lead to better outcomes, though challenges remain in integrating these practices into standard healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management education: history, definition, outcomes, and mechanisms. Lorig, KR., Holman, H.[2022]

Self-management interventions empower patients to actively participate in their care, which has become increasingly recognized as essential for managing chronic diseases and improving overall well-being.

The systematic review highlights that self-management programs have shown effectiveness in clinical studies over the past decade, indicating their importance in quality care and suggesting the need for further research to enhance these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of rheumatic diseases: state of the art and future perspectives. Iversen, MD., Hammond, A., Betteridge, N.[2022]

Using product feedback combining interbeat interval (IBI) and pulse transit time (PTT) was more effective than simple heart rate and blood pressure measurements in helping volunteers control their cardiovascular responses during exercise.

Preliminary feedback training in 7 anginal patients indicated potential benefits, such as reduced nitroglycerin use, fewer anginal attacks, and improved exercise tolerance, suggesting a promising therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-control of interbeat interval and pulse transit time at rest and during exercise. A preliminary report. Jonhston, DW., Lo, CR., Marie, GV., et al.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/search/qOy84gvXGECrFceWiYt5_w/project-details/10722157

RePORT RePORTER - National Institutes of Health (NIH) | SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions ...

2. withpower.com withpower.com/trial/phase-fractures-stress-11-2023-daf08

Self-Management Training for Stress Reaction After ICD ... The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe ...

3. reporter.nih.gov reporter.nih.gov/search/ZpkIhNcG202f-CRp7V-SeQ/project-details/10722157

Biobehavioral Intervention to Reduce PTSD Symptoms ... The study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the development of severe ...

4. allclinicaltrials.com allclinicaltrials.com/study/NCT06037785

Self-Management Interventions After an ICD Shock This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock," addresses a critical need in cardiology care by describing the ...

5. bmccardiovascdisord.biomedcentral.com bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-022-02782-8

Physical function, psychological adjustment, and self-efficacy ... SCA survivors had greater number of physical symptoms, lower levels of mental health and outcome expectations over 12 months despite participation in a SCT ...

6. trialx.com trialx.com/clinical-trials/listings/305660/self-management-interventions-after-an-icd-shock/

Self-Management Interventions After an ICD Shock SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. The study interventions ...