Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Anxiety Disorders; Cognitive Therapy
• Intervention / Treatment: Behavioral: Cognitive-behavioural therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital
  • Copenhagen O, Denmark, 2100
    • Rigshospitalet
  • Hellerup, Denmark, 2900
    • Herlev and Gentofte Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group - cognitive behavioral therapy; The intervention consists of three parts: 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 is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.	Behavioral: Cognitive-behavioural therapy; Cognitive-behavioural therapy intervention
No Intervention: Usual Care group; The usual care group (control group) will receive usual care which consists cardiac disease control and treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol level	The level of Cortisol measured in a blood sample.	Baseline, 5 months
C-reactive protein (CRP)	CRP is measured in a blood sample.	Baseline, 5 months
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
Health behaviour - Sleep quality	Patients' own evaluation of sleep quality.	Baseline, 5 months and 12 months
Health behaviour - Physical activity	Patients' own evaluation of physical activity.	Baseline, 5 months and 12 months
Health behaviour - Alcohol	Number of alcohol units per week.	Baseline, 5 months and 12 months
Health behaviour - Smoking	Number of cigarettes per day.	Baseline, 5 months and 12 months
Health behaviour - Weight.	Weight in kilogram.	Baseline, 5 months and 12 months
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
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
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital; Aalborg University Hospital; Herlev and Gentofte Hospital
• Investigators: Principal Investigator: Selina K Berg, PhD, Copenhagen University Hospital, Rigshospitalet, Denmark.

Publications and helpful links

General Publications

• Berg SK, Herning M, Schjodt I, Thorup CB, Juul C, Svendsen JH, Jorgensen MB, Risom SS, Christensen SW, Thygesen L, Rasmussen TB. The heart & mind trial: intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety: randomised controlled trial protocol. BMJ Open. 2021 Dec 3;11(12):e057085. doi: 10.1136/bmjopen-2021-057085.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Cognitive Therapy; Heart diseases
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Heart Diseases; Anxiety Disorders
• Other Study ID Numbers: The Heart & Mind Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No