Implantable Defibrillator User, Ptsd, Social Cognitive Theory, Stress Management, Stress Reaction
Conditions
Keywords
implantable cardioverter defibrillator, ptsd, stress management
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.
Interventions
BEHAVIORALSelf-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.
Sponsors
East Carolina University
National Institute of Nursing Research (NINR)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICD Shock anxiety | Baseline, 1, 6 months | Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life-Physical and Mental | Baseline, 1, 6 months | PROMIS Global v 2.0, 0-50. Higher is higher qol. |
| 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. |
| 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 |
| Self-Efficacy Expectations | Baseline, 1, 6 months | Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention (composite outcome) | 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. |
| Safety (composite outcome) of the intervention | 2 years of the trial | Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no. Each outcome is score and the total number is summarized. |
| Feasibility of implementing the intervention (composite outcome) | 6 months | 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. They elements are added together to get a score. |
Countries
United States
Contacts
Primary ContactCynthia M Dougherty, ARNP, PhD
Outcome results
None listed