Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
Primary Purpose
Hypertrophic Cardiomyopathy, Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Hypertrophic Cardiomyopathy
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Arm
Control Arm
Arm Description
Participants will receive psychotherapy for once a week.
Participants will not receive any treatment for depression.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Changes in frequency of Syncope
A risk factor of sudden death
Changes in frequency of Arrhythmia
A risk factor of sudden death
Changes in Generalized Anxiety Disorder (GAD) -7
A scale to test the severity of anxiety
Changes in Patient Health Questionnaire (PHQ) -9
A scale to test the severity of depression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03706001
Brief Title
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
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2018 (Anticipated)
Primary Completion Date
September 20, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy, Depression, Anxiety, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Participants will receive psychotherapy for once a week.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants will not receive any treatment for depression.
Intervention Type
Other
Intervention Name(s)
Psychotherapy
Intervention Description
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
Primary Outcome Measure Information:
Title
Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
Description
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.
Time Frame
Baseline, week 2, 4, 8
Secondary Outcome Measure Information:
Title
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
Description
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.
Time Frame
Baseline, week 2, 4, 8
Title
Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
Description
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.
Time Frame
Baseline, week 2, 4, 8
Title
Changes in frequency of Syncope
Description
A risk factor of sudden death
Time Frame
Baseline, week 2, 4, 8
Title
Changes in frequency of Arrhythmia
Description
A risk factor of sudden death
Time Frame
Baseline, week 2, 4, 8
Title
Changes in Generalized Anxiety Disorder (GAD) -7
Description
A scale to test the severity of anxiety
Time Frame
Baseline, week 2, 4, 8
Title
Changes in Patient Health Questionnaire (PHQ) -9
Description
A scale to test the severity of depression
Time Frame
Baseline, week 2, 4, 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huaning Wang, Doctor
Phone
(+86)13609161341
Email
13609161341@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjun Wu, Master
Phone
(+86)15829376756
Email
wenjun104@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liwen Liu, Doctor
Organizational Affiliation
Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Wang, Master
Organizational Affiliation
Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Huaning Wang, Doctor
Organizational Affiliation
Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wenjun Wu, Master
Organizational Affiliation
Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigator have not decided whether or not to share the data.
Citations:
PubMed Identifier
28235781
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.
Results Reference
background
PubMed Identifier
18164940
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.
Results Reference
result
PubMed Identifier
27326027
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.
Results Reference
result
Learn more about this trial
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
We'll reach out to this number within 24 hrs