Self-Management Interventions After an ICD Shock

Официальное название

Biobehavioral Intervention to Reduce PTSD After ICD Shock

Обзор

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.

Вмешательства

• Поведенческое Self-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.

Первичные конечные точки

• ICD Shock anxiety [Срок оценки: Baseline, 1, 6 months]

Вторичные конечные точки (8)

• Total daily physical activity(steps/day) [Срок оценки: Baseline, 1, 6 months]
• Depression [Срок оценки: Baseline, 1, 6 months]
• PTSD Symptoms [Срок оценки: Baseline, 1, 6 months]
• Quality of Life-Physical and Mental [Срок оценки: Baseline, 1, 6 months]
• Self-Efficacy Expectations [Срок оценки: Baseline, 1, 6 months]
• Outcome expectation, 0-90. Higher is higher OE. [Срок оценки: Baseline, 1, 6 months]
• Salivary cortisol [Срок оценки: Baseline, 1, 6 months]
• Acceptability [Срок оценки: 6 months]

Критерии участия

Критерии включения

• ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA),
• receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to enrollment;
• able to read, speak and write English;
• access to online resources and telephone for study duration.

Критерии исключения

• current diagnosis of PTSD, schizophrenia or bipolar disorder;
• Short BLESSED score >6 indicating cognitive dysfunction \[73\];
• age <18 years;
• AUDIT-C score ≥4 for alcohol use;
• regular non-medical use of illicit drugs

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT06037785 · STUDY00007840 · 1R21NR020967-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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