Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression

Conditions
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Hypertrophic Cardiomyopathy, Depression, Anxiety, Psychotherapy

Intervention / Treatment
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* Other: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as hypertrophic cardiomyopathy; Diagnosed as depression; Exclusion Criteria: Patients with left ventricular ejection fraction (EF) ≦ 30%; Renal dysfunction with serum creatinine ≧451umol/l; Severe heart failure and New York Heart Association (NYHA) Heart Failure Grade III; Combine with any type of malignant tumor; Combine with other serious mental illnesses such as bipolar disorder, schizophrenia, schizophrenia-like illness, severe dementia, etc.; Have received medication of antidepressant or psychotherapy; Patients with major depression; Patients with a serious risk of suicide or have had suicide attempts; Pregnant women and lactating women, or women who are planning to become pregnant or breastfeeding during the study period; Other circumstances in which the researcher judges that it is not suitable as a research object.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Participants will receive psychotherapy for once a week. | Other: Psychotherapy<br>* Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.<br>|
| No Intervention: Control Arm<br>Participants will not receive any treatment for depression. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, week 2, 4, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, week 2, 4, 8 | 
| Changes in frequency of Syncope | A risk factor of sudden death | Baseline, week 2, 4, 8 | 
| Changes in frequency of Arrhythmia | A risk factor of sudden death | Baseline, week 2, 4, 8 | 
| Changes in Generalized Anxiety Disorder (GAD) -7 | A scale to test the severity of anxiety | Baseline, week 2, 4, 8 | 
| Changes in Patient Health Questionnaire (PHQ) -9 | A scale to test the severity of depression | Baseline, week 2, 4, 8 |