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

Conditions

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.

Study Contact

Study Contact Backup

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.
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.

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

Xijing Hospital

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

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

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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