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.
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
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
336
Cognitive-behavioural therapy intervention
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Rigshospitalet
Copenhagen O, Denmark
Herlev and Gentofte Hospital
Hellerup, Denmark
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.
Time frame: 5 months
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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