Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2020-09-24
Brief Title:
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease The Heart Mind Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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 hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention The aim of Heart Mind Trial is I to determine the type of anxiety in cardiac patients and ii to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care
Detailed Description:
The Heart Mind Trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment including four university hospitals with 11 randomisation to cognitive therapy plus usual care or usual care alone
The intervention all patients receive usual care Patients in the intervention group will receive an intervention based on cognitive behavioral therapy
The intervention consists of three steps 1 screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale HADS scores 8 are invited to participate 2 Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders SCID 3 Investigator-initiated randomised clinical superiority trial with blinded outcome assessment with 11 randomisation to cognitive-behavioural therapy CBT performed by a cardiac nurse with CBT training plus usual care or usual care alone
The intervention all patients receive usual care Patients in the intervention group will receive an intervention based on cognitive behavioral therapy
The intervention consists of three steps 1 screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale HADS scores 8 are invited to participate 2 Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders SCID 3 Investigator-initiated randomised clinical superiority trial with blinded outcome assessment with 11 randomisation to cognitive-behavioural therapy CBT performed by a cardiac nurse with CBT training plus usual care or usual care alone
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