Anxiety Disorders, Cognitive Therapy, Heart Diseases
Conditions
Keywords
Cognitive Therapy, Anxiety, Heart diseases
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.
Interventions
BEHAVIORALCognitive-behavioural therapy
Cognitive-behavioural therapy intervention
Sponsors
Herlev and Gentofte Hospital
Aalborg University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
Because of the conditions required for psycho-educational interventions, it is not possible to blind the intervention staff and patients. All baseline information and clinical interviews are collected and performed before randomization. Physical tests, data collection, data management and administration will be done by blinded staff. Statistical analysis of outcomes and conclusions from these will be blinded. Results of the trial are analysed by an independent statistician, and the results will be interpreted by the research group. The conclusion will be prepared in two versions, before the allocation code is broken, with the two arms alternately assumed as intervention (one that assumes that arm A is the intervention, and second, that assumes that the arm B intervention).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) Anxiety | 5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Becks Anxiety Inventory (BAI) | Baseline, 5 months and 12 months | 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. |
| Heart rate variability (HRV) | Baseline, 5 months | 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. |
| Hospital Anxiety and Depression Scale (HADS) Anxiety | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health behaviour - Physical activity | Baseline, 5 months and 12 months | Patients' own evaluation of physical activity. |
| Health behaviour - Alcohol | Baseline, 5 months and 12 months | Number of alcohol units per week. |
| Health behaviour - Smoking | Baseline, 5 months and 12 months | Number of cigarettes per day. |
| Cortisol level | Baseline, 5 months | The level of Cortisol measured in a blood sample. |
| Number of participants with admissions, readmissions and number of patients who died during the trial period. | 12 months | Data regarding admissions, redadmissions and mortality through registers. |
| Hospital Anxiety and Depression Scale (HADS) Depression | Baseline, (intervention group: every CBT session), 5 months and 12 months | 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. |
| Hospital Anxiety and Depression Scale (HADS) Anxiety | 12 months | 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. |
| Health behaviour - Weight. | Baseline, 5 months and 12 months | Weight in kilogram. |
| C-reactive protein (CRP) | Baseline, 5 months | CRP is measured in a blood sample. |
| Heart Quality of Life (HeartQoL) | Baseline, 5 months and 12 months | 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. |
| Health behaviour - Sleep quality | Baseline, 5 months and 12 months | Patients' own evaluation of sleep quality. |
Countries
Denmark
Outcome results
None listed