An interventional study of Self-Paced Self-Management (SPSM) in Implantable Defibrillator User, Stress Reaction and Ptsd, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
168 studies on the registry are indexed under Fractures, Stress; 41 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 134 interventional studies indexed under Fractures, Stress.
Browse Fractures, Stress studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Heart rate self monitoring Online shock management modules
Behavioral: Self-Paced Self-Management (SPSM)
standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor
(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.
ICD Shock anxiety
Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
Time frame: Baseline, 1, 6 months
Total daily physical activity(steps/day)
Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
Time frame: Baseline, 1, 6 months
Depression
PHQ-9, 0-27. Higher is higher depression.
Time frame: Baseline, 1, 6 months
PTSD Symptoms
Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
Time frame: Baseline, 1, 6 months
Quality of Life-Physical and Mental
PROMIS Global v 2.0, 0-50. Higher is higher qol.
Time frame: Baseline, 1, 6 months
Self-Efficacy Expectations
Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
Time frame: Baseline, 1, 6 months
Outcome expectation, 0-90. Higher is higher OE.
OE Scale
Time frame: Baseline, 1, 6 months
Salivary cortisol
Cortisol in saliva, the range in humans varies. measured in pg/ml.
Time frame: Baseline, 1, 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.
Time frame: 6 months
Feasibility of implementing the intervention (composite outcome)
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.
Time frame: 6 months
Safety (composite outcome) of the intervention
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.
Time frame: 2 years of the trial
Acceptability of the intervention (composite outcome)
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.
Time frame: 6 months
Plan to share: Yes — To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
Supporting information: Study protocol
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