Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2018
CompletedFirst Posted
Study publicly available on registry
October 15, 2018
CompletedStudy Start
First participant enrolled
October 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 15, 2018
September 1, 2018
11 months
September 29, 2018
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
Baseline, week 2, 4, 8
Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
Baseline, week 2, 4, 8
Changes in frequency of Syncope
Baseline, week 2, 4, 8
Changes in frequency of Arrhythmia
Baseline, week 2, 4, 8
Changes in Generalized Anxiety Disorder (GAD) -7
Baseline, week 2, 4, 8
- +1 more secondary outcomes
Study Arms (2)
Experimental Arm
EXPERIMENTALParticipants will receive psychotherapy for once a week.
Control Arm
NO INTERVENTIONParticipants will not receive any treatment for depression.
Interventions
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
Eligibility Criteria
You may qualify if:
- Diagnosed as hypertrophic cardiomyopathy;
- Diagnosed as depression;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Related 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.
PMID: 28235781BACKGROUNDMorgan 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.
PMID: 18164940RESULTIgoumenou 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.
PMID: 27326027RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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.
- STUDY CHAIR
Huaning Wang, Doctor
Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
- PRINCIPAL INVESTIGATOR
Wenjun Wu, Master
Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2018
First Posted
October 15, 2018
Study Start
October 20, 2018
Primary Completion
September 20, 2019
Study Completion
December 31, 2019
Last Updated
October 15, 2018
Record last verified: 2018-09