Self-Management Interventions After an ICD Shock

Not Applicable

Not yet recruiting

• Conditions: Implantable Defibrillator User; Stress Reaction; Social Cognitive Theory; Ptsd; Stress Management
• Interventions: Behavioral: Self-Paced Self-Management (SPSM)

• Registration Number: NCT06037785
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-07
• Last Update Submitted: 2023-09-07
• Study First Posted: 2023-09-14
• Last Update Posted: 2023-09-14
• Study Start: 2023-12-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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 [74]; and 5) regular non-medical use of illicit drugs

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPSM intervention	Self-Paced Self-Management (SPSM)	Heart rate self monitoring Online shock management modules

Primary Outcome Measures

Name	Time	Method
ICD Shock anxiety	Baseline, 1, 6 months	Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.

Secondary Outcome Measures

Name	Time	Method
Total daily physical activity(steps/day)	Baseline, 1, 6 months	Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
Depression	Baseline, 1, 6 months	PHQ-9, 0-27. Higher is higher depression.
PTSD Symptoms	Baseline, 1, 6 months	Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
Quality of Life-Physical and Mental	Baseline, 1, 6 months	PROMIS Global v 2.0, 0-50. Higher is higher qol.
Self-Efficacy Expectations	Baseline, 1, 6 months	Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
Outcome expectation, 0-90. Higher is higher OE.	Baseline, 1, 6 months	OE Scale
Salivary cortisol	Baseline, 1, 6 months	Cortisol in saliva, the range in humans varies. measured in pg/ml.
Acceptability	6 months	Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires \& data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States