Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

Heart Diseases Clinical Trial

Official title:

Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04582734
• Other study ID #: The Heart & Mind Trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: May 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be =18 years

• Diagnosed with cardiac disease

• Speak and understand Danish

• Score =8 on the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)

• HADS-A score must exceed the HADS-D score

• Gives written informed consent.

Related Conditions & MeSH terms

• Anxiety Disorders
• Cognitive Therapy
• Heart Diseases

Intervention

Behavioral:
• Cognitive-behavioural therapy
Cognitive-behavioural therapy intervention

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Rigshospitalet	Copenhagen O
Denmark	Herlev and Gentofte Hospital	Hellerup

Sponsors (4)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol level	The level of Cortisol measured in a blood sample.	Baseline, 5 months
Other	C-reactive protein (CRP)	CRP is measured in a blood sample.	Baseline, 5 months
Other	Heart Quality of Life (HeartQoL)	The questionnaire measures health-related quality of life in patients with ischemic heart disease, specifically angina, myocardial infarction or ischemic heart failure. The questionnaire consists of 14 items and provides two subscales; a 10-item physical subscale and a 4-item emotional subscale which each are scored from 0 to 3. The score ranges from 0-42. A higher score indicates a better heart related quality of life.	Baseline, 5 months and 12 months
Other	Health behaviour - Sleep quality	Patients' own evaluation of sleep quality.	Baseline, 5 months and 12 months
Other	Health behaviour - Physical activity	Patients' own evaluation of physical activity.	Baseline, 5 months and 12 months
Other	Health behaviour - Alcohol	Number of alcohol units per week.	Baseline, 5 months and 12 months
Other	Health behaviour - Smoking	Number of cigarettes per day.	Baseline, 5 months and 12 months
Other	Health behaviour - Weight.	Weight in kilogram.	Baseline, 5 months and 12 months
Other	Number of participants with admissions, readmissions and number of patients who died during the trial period.	Data regarding admissions, redadmissions and mortality through registers.	12 months
Other	Hospital Anxiety and Depression Scale (HADS) Depression	Depression measured by HADS-D. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.; Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.	Baseline, (intervention group: every CBT session), 5 months and 12 months
Other	Hospital Anxiety and Depression Scale (HADS) Anxiety	Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.; Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.	12 months
Primary	Hospital Anxiety and Depression Scale (HADS) Anxiety	Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.; Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.	5 months
Secondary	Becks Anxiety Inventory (BAI)	Becks Anxiety Inventory is a brief self-reported measure of anxiety with a focus on somatic symptoms of anxiety and was developed as a measure to discriminate between anxiety and depression. Respondents indicated how much each symptom has bothered them during the past week on a 4-point Likert scale ranging from 0 (not at all) to 3 (severely).; The BAI score ranges from 0-63.	Baseline, 5 months and 12 months
Secondary	Heart rate variability (HRV)	HRV is measured using a Holter monitor. HRV are responsive to sympathetic activity, which can be increased by anxiety. HRV refers to the beat-to-beat variation in the RR interval and is a marker of autonomic nervous system activity.	Baseline, 5 months
Secondary	Hospital Anxiety and Depression Scale (HADS) Anxiety	Primary outcome is anxiety measured by HADS-A. HADS is a 14 item questionnaire that assesses anxiety and depression level in medical ill persons who are not admitted in psychiatric wards.; Scores of 0 to 7 for either subscale are regarded as normal and scores of 8 to 10 suggest the presence of a mood disorder. Scores of 11 and above suggest probable presence of a mood disorder.	Baseline