Clinical trial NCT06037785: Self-Management Interventions After an ICD Shock
Official title: Biobehavioral Intervention to Reduce PTSD After ICD Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implantable Defibrillator User
Stress Reaction
Ptsd
Stress Management
Social Cognitive Theory
Keywords: implantable cardioverter defibrillator
ptsd
stress management
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: East Carolina University
name: National Institute of Nursing Research (NINR)
First posted: 2023-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ICD Shock anxiety
timeFrame: Baseline, 1, 6 months
Secondary outcomes:
measure: Total daily physical activity(steps/day)
timeFrame: Baseline, 1, 6 months
measure: Depression
timeFrame: Baseline, 1, 6 months
measure: PTSD Symptoms
timeFrame: Baseline, 1, 6 months
measure: Quality of Life-Physical and Mental
timeFrame: Baseline, 1, 6 months
measure: Self-Efficacy Expectations
timeFrame: Baseline, 1, 6 months
measure: Outcome expectation, 0-90. Higher is higher OE.
timeFrame: Baseline, 1, 6 months
measure: Salivary cortisol
timeFrame: Baseline, 1, 6 months
measure: Acceptability
timeFrame: 6 months
Other outcomes:
measure: Feasibility of implementing the intervention (composite outcome)
timeFrame: 6 months
measure: Safety (composite outcome) of the intervention
timeFrame: 2 years of the trial
measure: Acceptability of the intervention (composite outcome)
timeFrame: 6 months
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia M Dougherty, ARNP, PhD
role: PRINCIPAL_INVESTIGATOR
References: