Self-Management Interventions After an ICD Shock

Study Overview
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Brief Summary
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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.

Official Title
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Biobehavioral Intervention to Reduce PTSD After ICD Shock

Conditions
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Stress Reaction, Implantable Defibrillator User, Ptsd, Stress Management, Social Cognitive Theory

Intervention / Treatment
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* Behavioral: Self-Paced Self-Management (SPSM)


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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPSM intervention<br>Heart rate self monitoring Online shock management modules | Behavioral: Self-Paced Self-Management (SPSM)<br>* (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.<br>|
| No Intervention: usual care<br>standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD Shock anxiety | Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety. | Baseline, 1, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total daily physical activity(steps/day) | Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps. | Baseline, 1, 6 months | 
| Depression | PHQ-9, 0-27. Higher is higher depression. | Baseline, 1, 6 months | 
| PTSD Symptoms | Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms | Baseline, 1, 6 months | 
| Quality of Life-Physical and Mental | PROMIS Global v 2.0, 0-50. Higher is higher qol. | Baseline, 1, 6 months | 
| Self-Efficacy Expectation | Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy | Baseline, 1, 6 months | 
| Outcome expectation, 0-90. Higher is higher OE. | OE Scale | Baseline, 1, 6 months | 
| Salivary cortisol | Cortisol in saliva, the range in humans varies. measured in pg/ml. | Baseline, 1, 6 months | 
| Feasibility | Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible & enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study. | 6 months | 
| Acceptability | 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. | 6 months | 
| Safety | Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable cardioverter defibrillator, ptsd, stress management