Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06037785
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-09-01
Brief Title:
Self-Management Interventions After an ICD Shock
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Biobehavioral Intervention to Reduce PTSD After ICD Shock
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 N60 30group 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21NR020967-01 | NIH | None | httpsreporternihgovquickSearch1R21NR020967-01 |