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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
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 29, 2018
    Last Updated
    October 10, 2018
    Sponsor
    Xijing Hospital
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    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

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

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