Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease: The Heart & Mind Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cognitive Therapy
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 336
- Locations
- 4
- Primary Endpoint
- Hospital Anxiety and Depression Scale (HADS) Anxiety
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Selina Kikkenborg Berg
Professor
Rigshospitalet, Denmark
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hospital Anxiety and Depression Scale (HADS) Anxiety
Time Frame: 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 Outcomes
- Becks Anxiety Inventory (BAI)(Baseline, 5 months and 12 months)
- Hospital Anxiety and Depression Scale (HADS) Anxiety(Baseline)
- Heart rate variability (HRV)(Baseline, 5 months)