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Self-Management Interventions After an ICD Shock

RecruitingNAAges 18 Years - anyAllUniversity of Washington
NCT06037785 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Self-Paced Self-Management (SPSM)
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Where

1 site
University of Washington
Seattle, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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