A Study to evaluate the efficacy of psychotherapy for easing the cardiac symptoms and improving and quality of life in patients with hypertrophic cardiomyopathy accompanied with depression
This study will use a 8 week parallel group design. 100 patients diagnosed as hypertrophic cardiomyopathy accompanied with depression will be into experimental group and control group. The experimental group received 8 times of psychological treatments for once each week; the control group did not receive any antidepressant treatment. Follow-up assessments will be performed at baseline, week 4 and 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) tests the quality of life and gives emphasis to the subjective perspective of patients on physical, psychological and social domains.
Time frame: Baseline, week 2, 4, 8
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
Hamilton Depression Rating Scale17 is a test measuring the severity of depressive symptoms in individuals. It is often used as an outcome measure of depression in research. In the 17-item version, nine of the items are scored on a five-point scale, ranging from 0 to 4. The remaining eight items are scored on a three-point scale. For the 17-item version, scores can range from 0 to 54. Scores from 0 to 6 indicate no depression, scores between 7 and 17 indicate mild depression, scores between 18 and 24 indicate moderate depression, and scores over 24 indicate severe depression.
Time frame: Baseline, week 2, 4, 8
Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
The HAM-A consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scores range from 0 to 56 where 14-17 indicates mild anxiety, 18-24 indicates moderate anxiety and scores of 25 and over indicate severe anxiety.
Time frame: Baseline, week 2, 4, 8
Changes in frequency of Syncope
A risk factor of sudden death
Time frame: Baseline, week 2, 4, 8
Changes in frequency of Arrhythmia
A risk factor of sudden death
Time frame: Baseline, week 2, 4, 8
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Changes in Generalized Anxiety Disorder (GAD) -7
A scale to test the severity of anxiety
Time frame: Baseline, week 2, 4, 8
Changes in Patient Health Questionnaire (PHQ) -9
A scale to test the severity of depression
Time frame: Baseline, week 2, 4, 8