Clinical trial NCT03706001: Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
Official title: Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Depression
Anxiety
Psychotherapy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
timeFrame: Baseline, week 2, 4, 8
Secondary outcomes:
measure: Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
timeFrame: Baseline, week 2, 4, 8
measure: Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
timeFrame: Baseline, week 2, 4, 8
measure: Changes in frequency of Syncope
timeFrame: Baseline, week 2, 4, 8
measure: Changes in frequency of Arrhythmia
timeFrame: Baseline, week 2, 4, 8
measure: Changes in Generalized Anxiety Disorder (GAD) -7
timeFrame: Baseline, week 2, 4, 8
measure: Changes in Patient Health Questionnaire (PHQ) -9
timeFrame: Baseline, week 2, 4, 8
Other outcomes:
Locations:
Study officials:
affiliation: Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Liwen Liu, Doctor
role: STUDY_DIRECTOR
affiliation: Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Bo Wang, Master
role: STUDY_DIRECTOR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Huaning Wang, Doctor
role: STUDY_CHAIR
affiliation: Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
name: Wenjun Wu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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/heartasia-2012-010099. eCollection 2012.