Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03706001
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Hypertrophic Cardiomyopathy Depression Anxiety Psychotherapy Other: Psychotherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Experimental Arm
Participants will receive psychotherapy for once a week.
Other: Psychotherapy
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Changes in frequency of Syncope [ Time Frame: Baseline, week 2, 4, 8 ]
    A risk factor of sudden death

  4. Changes in frequency of Arrhythmia [ Time Frame: Baseline, week 2, 4, 8 ]
    A risk factor of sudden death

  5. Changes in Generalized Anxiety Disorder (GAD) -7 [ Time Frame: Baseline, week 2, 4, 8 ]
    A scale to test the severity of anxiety

  6. Changes in Patient Health Questionnaire (PHQ) -9 [ Time Frame: Baseline, week 2, 4, 8 ]
    A scale to test the severity of depression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706001


Contacts
Layout table for location contacts
Contact: Huaning Wang, Doctor (+86)13609161341 13609161341@163.com
Contact: Wenjun Wu, Master (+86)15829376756 wenjun104@126.com

Sponsors and Collaborators
Xijing Hospital
Investigators
Layout table for investigator information
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 of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03706001     History of Changes
Other Study ID Numbers: KY20182033-1
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigator have not decided whether or not to share the data.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases