Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05607992
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2022-10-27
Brief Title:
Brief Internet-delivered CBT After ACS
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Brief Internet-delivered Exposure-based Therapy to Reduce Post-traumatic Stress Symptoms and Cardiac Anxiety After Acute Coronary Syndrome a Pilot Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-08
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:
The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief internet-delivered CBT protocol provided early after acute coronary syndrome ACS
Detailed Description:
Acute coronary syndrome ACS myocardial infarction MI or unstable angina UA is one of the leading causes of mortality and health loss globally ACS is a stressful and potentially life-threatening cardiovascular event and many patients develop symptoms of post-traumatic stress PTSS and cardiac anxiety post ACS which have been shown to negatively affect patients long-term cardiovascular prognosisThe aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS cardiac anxiety and increase physical activity and quality of life Patients with recent ACS 4 weeks to 6 months and with elevated PTSS and anxiety will be eligible After informed consent patients will be randomized to internet-delivered CBT N15 or to a wait-list control group N15 The treatment is a 5 week therapist-guided internet-delivered intervention which includes imaginal exposure interoceptive exposure and exposure in-vivo Assessments will be conducted at baseline immediate post-treatment and 2- and 6- months after treatment The wait-list will be crossed over to CBT after completion of the 2 month follow-up
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