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

NCT ID: NCT03706001

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-20

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Hypertrophic Cardiomyopathy Depression Anxiety Psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Arm

Participants will receive psychotherapy for once a week.

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type OTHER

Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.

Control Arm

Participants will not receive any treatment for depression.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy

Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liwen Liu, Doctor

Role: STUDY_DIRECTOR

Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.

Bo Wang, Master

Role: STUDY_DIRECTOR

Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.

Huaning Wang, Doctor

Role: STUDY_CHAIR

Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.

Wenjun Wu, Master

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.

Central Contacts

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Huaning Wang, Doctor

Role: CONTACT

(+86)13609161341

Wenjun Wu, Master

Role: CONTACT

(+86)15829376756

References

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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.

Reference Type BACKGROUND
PMID: 28235781 (View on PubMed)

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.

Reference Type RESULT
PMID: 18164940 (View on PubMed)

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.

Reference Type RESULT
PMID: 27326027 (View on PubMed)

Other Identifiers

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KY20182033-1

Identifier Type: -

Identifier Source: org_study_id

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