Self-Management Interventions After an ICD Shock

NCT ID: NCT06037785

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-07-31

Brief Summary

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.

Conditions

Implantable Defibrillator User; Stress Reaction; Ptsd; Stress Management; Social Cognitive Theory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPSM intervention

Heart rate self monitoring Online shock management modules

Group Type: EXPERIMENTAL

Self-Paced Self-Management (SPSM)

Intervention Type: BEHAVIORAL

(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.

usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self-Paced Self-Management (SPSM)

(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),

2. receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;

3. able to read, speak and write English;

4. access to online resources and telephone for study duration.

Exclusion Criteria

1. current diagnosis of PTSD, schizophrenia or bipolar disorder;

2. Short BLESSED score >6 indicating cognitive dysfunction [73];

3. age <18 years;

4. AUDIT-C score ≥4 for alcohol use;

5. regular non-medical use of illicit drugs

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East Carolina University

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia M. Dougherty

Professor, School of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia M Dougherty, ARNP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cynthia M Dougherty, ARNP, PhD

Role: CONTACT

cindyd@uw.edu

206 221-7927

Facility Contacts

Cynthia Dougherty, ARNP, PhD

Role: primary

cindyd@u.washington.edu

206-221-7927

Other Identifiers

1R21NR020967-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007840

Identifier Type: -

Identifier Source: org_study_id