Self-Management Interventions After an ICD Shock

NCT06037785 | Recruiting

• 2 other identifiers: STUDY000078401R21NR020967-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

implantable cardioverter defibrillator; ptsd; stress management

Outcome Measures

Primary Outcomes (1)

• ICD Shock anxiety

  Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.

  Baseline, 1, 6 months

Secondary Outcomes (8)

• Total daily physical activity(steps/day)

  Baseline, 1, 6 months

• Depression

  Baseline, 1, 6 months

• PTSD Symptoms

  Baseline, 1, 6 months

• Quality of Life-Physical and Mental

  Baseline, 1, 6 months

• Self-Efficacy Expectations

  Baseline, 1, 6 months

Other Outcomes (3)

• Feasibility of implementing the intervention (composite outcome)

  6 months

• Safety (composite outcome) of the intervention

  2 years of the trial

• Acceptability of the intervention (composite outcome)

  6 months

Study Arms (2)

SPSM intervention

EXPERIMENTAL

Heart rate self monitoring Online shock management modules

Behavioral: Self-Paced Self-Management (SPSM)

usual care

NO INTERVENTION

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

Interventions

Self-Paced Self-Management (SPSM) 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.

SPSM intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
• receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
• able to read, speak and write English;
• access to online resources and telephone for study duration.

You may not qualify if:

• current diagnosis of PTSD, schizophrenia or bipolar disorder;
• Short BLESSED score \>6 indicating cognitive dysfunction \[73\];
• age \<18 years;
• AUDIT-C score ≥4 for alcohol use;
• regular non-medical use of illicit drugs

Sponsors & Collaborators

• University of Washington: lead
• East Carolina University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Fractures, Stress; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Cynthia M Dougherty, ARNP, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia M Dougherty, ARNP, PhD

CONTACT

206 221-7927; cindyd@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after trial completion, available for up to 5 years after trial completion
• Access Criteria: Contact PI

Locations

US (1)