Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-13 @ 7:48 AM
Study NCT ID:
NCT05607992
Status:
COMPLETED
Last Update Posted:
2024-08-27
First Post:
2022-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brief Internet-delivered CBT After ACS
Sponsor:
Karolinska Institutet
Organization:
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 prognosis.The 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 (N=15) or to a wait-list control group (N=15). 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:
False
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?: