Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-06 @ 3:32 AM
Study NCT ID:
NCT04582734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2020-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease
Sponsor:
Rigshospitalet, Denmark
Organization:
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 1:1 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 1:1 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 1:1 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:
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?: