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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03706001
• Other study ID #: KY20182033-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2018
• Source: Xijing Hospital
• Contact: Huaning Wang, Doctor
• Phone: (+86)13609161341
• Email: 13609161341[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Depression
• Depressive Disorder
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Psychotherapy

Intervention

Other:
• Psychotherapy
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

References & Publications (3)

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. — View Citation

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/hea — View Citation

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. — View Citation

Outcome

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