Anxiety, Depression, Hypertrophic Cardiomyopathy, Psychotherapy
Conditions
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.
Interventions
OTHERPsychotherapy
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Syncope | Baseline, week 2, 4, 8 | A risk factor of sudden death |
| Changes in frequency of Arrhythmia | Baseline, week 2, 4, 8 | A risk factor of sudden death |
| Changes in Generalized Anxiety Disorder (GAD) -7 | Baseline, week 2, 4, 8 | A scale to test the severity of anxiety |
| Changes in Patient Health Questionnaire (PHQ) -9 | Baseline, week 2, 4, 8 | A scale to test the severity of depression |
Contacts
Primary ContactHuaning Wang, Doctor
Backup ContactWenjun Wu, Master
Outcome results
None listed