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Brain & Heart                                                   Depression, anxiety and blood pressure control



            •   Dementia                                       36 questions, which address physical functioning and
            •   Severe valvulopathies                          role, body pain, general health, vitality, social functioning,
            •   Heart failure with ejection fraction <35%      emotional role, and mental health.
            •   Severe systematic illness with survival prognosis of
               <1 year                                         3.3. Second phase
            •   Cancer under treatment (radiotherapy/chemotherapy/  The second phase will enroll 200 patients with hypertension
               immunotherapy)                                  and a HADS score of ≥11.
            •   Established diagnosis of psychiatric disease (treated   Patients with hypertension and high HADS scores will be
               or  not)
            •   Unwillingness to participate.                  classified to receive the following:
                                                               •
                                                                  Psychiatric intervention and treatment
            3.1.5. Follow-up duration                          •   Standard follow-up
            The follow-up duration will be 12 months. A pilot study   Toward this process, patients will be fully informed
            was conducted, and preliminary data indicated an effect on   regarding participation in the second phase.
            BP levels within the first 3 months. Therefore, a follow-up   •   Patients who will decline psychiatric evaluation will
            period of 12  months is sufficient to detect significant   be enrolled in the standard group.
            outcomes.                                          •   Patients who will ask for psychiatric evaluation will be
                                                                  enrolled in the intervention group.
            3.1.6. Study population                            •   All the remaining patients will be randomized equally.

            The study population included patients with hypertension   Regarding the nature of the psychiatric intervention, all
            in the Hypertension Unit of the First Cardiology Clinic,   patients with hypertension and high depression/stress levels
            Athens Medical School, National and Kapodistrian   based on the HADS and confirmed depression/stress post-
            University of Athens.                              psychiatric evaluation will be prescribed antidepressants.

            3.2. Step one: Responses of the HADS and SF-36     Moreover, they will be asked to undergo follow-up in the
            quality-of-life questionnaire                      behavioral unit of the hypertension unit of our department
                                                               to assess the possible initiation of psychotherapy.
            According to HADS results, patients with hypertension will
            be classified into those with high and low HADS scores.  3.4. Data collection
              The HADS  was developed in 1983 by A. S. Zigmond   A specific care report form will be used for data collection,
                       67
            and R. P. Snaith and is used to screen patients with   including demographic and somatometric data, medical
            depression or anxiety. It cannot be used as a diagnostic   history, laboratory results, and hypertensive target organ
            tool but only as a screening tool. The questionnaire can be   damage  information.  All  patients  with  hypertension
            answered within 5 min. It contains 14 questions (7 items   and high HADS scores, irrespective of randomization,
            on anxiety and 7 on depression). Every question has four   will  undergo electrocardiography, ambulatory BP
            possible answers, and each one answer is assigned a specific   measurement, and cardiac ultrasonography.
            number (0 – 3). Scoring results are classified accordingly:  Specifically, the following parameters will be recorded:
            0 – 7: Normal score (no chance of depression/anxiety)  sex, height, weight, waist and hip circumferences,
            8 – 10: Marginal (average chance of depression/anxiety)  smoking status, hypertension history, diabetes mellitus,
            11 – 21: Abnormal (increased chance of depression/  and dyslipidemia status, family history of coronary artery
            anxiety)                                           disease, and medical information regarding coronary
                                                               artery disease, heart failure, atrial fibrillation, chronic
              Subsequently, patients with hypertension and a HADS
            score of ≥11 will be enrolled in the second phase.  kidney disease, peripheral arterial disease, sleep apnea,
                                                               stroke, and drugs administered.
              The Health Survey Questionnaire Short Form  was
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            developed in 1992 by Ware to estimate the health state   Electrocardiogram data: Sinus rhythm or atrial
            of inpatients. It has been used to assess the quality of life   fibrillation, heart rate, PR, QRS, QT (QTc and QTd), Q
            of the population. The questionnaire can be completed   waves, T-wave inversion, bundle branch block, and axis.
            in 5 – 10  min. It has two forms: SF-36 and SF-12. The   Cardiac ultrasound data: Left ventricular mass index,
            questionnaire aims to document patients’ mental and   left ventricular end-diastolic diameter, left atrial diameter,
            physical conditions. It is considered a reliable instrument   left atrial volume index, aortic root diameter, E, E/A, Em,
            with Cronbach’s α of >0.70. The long version consists of   and E/Em.


            Volume 3 Issue 1 (2025)                         6                                doi: 10.36922/bh.4923
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