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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Participants will receive psychotherapy for once a week. |
|
| Control Arm | No Intervention | Participants will not receive any treatment for depression. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychotherapy | Other | Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaning Wang, Doctor | Contact | (+86)13609161341 | 13609161341@163.com | |
| Wenjun Wu, Master | Contact | (+86)15829376756 | wenjun104@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liwen Liu, Doctor | Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Study Director |
| Bo Wang, Master | Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28235781 | Background | Dossat AM, Sanchez-Gonzalez MA, Koutnik AP, Leitner S, Ruiz EL, Griffin B, Rosenberg JT, Grant SC, Fincham FD, Pinto JR, Kabbaj M. Pathogenesis of depression- and anxiety-like behavior in an animal model of hypertrophic cardiomyopathy. FASEB J. 2017 Jun;31(6):2492-2506. doi: 10.1096/fj.201600955RR. Epub 2017 Feb 24. | |
| 18164940 |
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The investigator have not decided whether or not to share the data.
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| Study Director |
| Huaning Wang, Doctor | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Study Chair |
| Wenjun Wu, Master | Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China. | Principal Investigator |
| Morgan JF, O'Donoghue AC, McKenna WJ, Schmidt MM. Psychiatric disorders in hypertrophic cardiomyopathy. Gen Hosp Psychiatry. 2008 Jan-Feb;30(1):49-54. doi: 10.1016/j.genhosppsych.2007.09.005. |
| 27326027 | Result | Igoumenou A, Alevizopoulos G, Anastasakis A, Stavrakaki E, Toutouzas P, Stefanadis C. Depression in patients with hypertrophic cardiomyopathy: is there any relation with the risk factors for sudden death? Heart Asia. 2012 Jan 1;4(1):44-8. doi: 10.1136/heartasia-2012-010099. eCollection 2012. |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |