Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298864
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-02-26
Brief Title:
Internet-based Behavioral Intervention Following ACS
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Internet-based Behavioral Intervention Following Acute Coronary Syndrome a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ACS-CBT
Brief Summary:
The aim of this study is to evaluate if an online Cognitive Behavioral Therapy CBT protocol customized for patients following Acute Coronary Syndrome ACS reduce cardiac anxiety enhance Quality of Life QoL and promote increased physical activity while controlling for caregiver attention utilizing an active control group receiving internet-based cardiac lifestyle intervention
Detailed Description:
ACS is a leading global cause of mortality and health-related losses Following ACS many individuals exhibit symptoms of anxiety and depression recognized risk factors for recurrent cardiovascular events Specifically anxiety related to cardiac symptoms and avoidance behavior known as cardiac anxiety has been shown to increase the long-term risk of adverse cardiac events
The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet
The aim of this study is to assess whether internet-based CBT following ACS reduces cardiac anxiety and improves QoL while controlling for caregiver attention and expectancy of improvement using an active control group
Method A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT N130 or internet-based cardiac lifestyle intervention internet-CL N130 The active control group receives internet-CL focusing on lifestyle modification and health-promoting behaviors Weekly therapist support through online written communication is provided to participants in both groups Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules intensity and attention from the treating psychologist
The purpose of the present interdisciplinary research project is to develop and evaluate an online CBT protocol tailored for ACS patients This project comprises a series of clinical studies aimed at accumulating knowledge about the most effective ways to treat ACS patients with CBT over the internet
The aim of this study is to assess whether internet-based CBT following ACS reduces cardiac anxiety and improves QoL while controlling for caregiver attention and expectancy of improvement using an active control group
Method A randomized controlled trial is conducted where participants are randomly assigned to either internet-based CBT N130 or internet-based cardiac lifestyle intervention internet-CL N130 The active control group receives internet-CL focusing on lifestyle modification and health-promoting behaviors Weekly therapist support through online written communication is provided to participants in both groups Both treatment are conducted over 8-weeks and are comparable in terms of the number of treatment modules intensity and attention from the treating psychologist
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