Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
- Conditions
- DepressionAnxietyHypertrophic CardiomyopathyPsychotherapy
- Interventions
- Other: Psychotherapy
- Registration Number
- NCT03706001
- Lead Sponsor
- Xijing Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Diagnosed as hypertrophic cardiomyopathy;
- Diagnosed as depression;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Psychotherapy Participants will receive psychotherapy for once a week.
- Primary Outcome Measures
Name Time Method Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time Baseline, week 2, 4, 8 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.
- Secondary Outcome Measures
Name Time Method Changes in Generalized Anxiety Disorder (GAD) -7 Baseline, week 2, 4, 8 A scale to test the severity of anxiety
Changes in The Hamilton Rating Scale for Anxiety (HAM-A) Baseline, week 2, 4, 8 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.
Changes in frequency of Arrhythmia Baseline, week 2, 4, 8 A risk factor of sudden death
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score Baseline, week 2, 4, 8 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.
Changes in frequency of Syncope Baseline, week 2, 4, 8 A risk factor of sudden death
Changes in Patient Health Questionnaire (PHQ) -9 Baseline, week 2, 4, 8 A scale to test the severity of depression