- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03706001
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
October 10, 2018 updated by: Xijing Hospital
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
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Arm
Participants will receive psychotherapy for once a week.
|
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
|
NO_INTERVENTION: Control Arm
Participants will not receive any treatment for depression.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time
Time Frame: Baseline, week 2, 4, 8
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
Time Frame: Baseline, week 2, 4, 8
|
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
|
Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
Time Frame: Baseline, week 2, 4, 8
|
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
Time Frame: Baseline, week 2, 4, 8
|
A risk factor of sudden death
|
Baseline, week 2, 4, 8
|
Changes in frequency of Arrhythmia
Time Frame: Baseline, week 2, 4, 8
|
A risk factor of sudden death
|
Baseline, week 2, 4, 8
|
Changes in Generalized Anxiety Disorder (GAD) -7
Time Frame: Baseline, week 2, 4, 8
|
A scale to test the severity of anxiety
|
Baseline, week 2, 4, 8
|
Changes in Patient Health Questionnaire (PHQ) -9
Time Frame: Baseline, week 2, 4, 8
|
A scale to test the severity of depression
|
Baseline, week 2, 4, 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 20, 2018
Primary Completion (ANTICIPATED)
September 20, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
September 29, 2018
First Submitted That Met QC Criteria
October 10, 2018
First Posted (ACTUAL)
October 15, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Heart Diseases
- Cardiovascular Diseases
- Mood Disorders
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Depression
- Depressive Disorder
- Hypertrophy
- Cardiomyopathies
- Cardiomyopathy, Hypertrophic
Other Study ID Numbers
- KY20182033-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The investigator have not decided whether or not to share the data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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