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

Sponsor

Xijing Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03706001

Collaborator

(none)

100

Enrollment

Arms

14.4

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy Depression Anxiety Psychotherapy	Other: Psychotherapy	N/A

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 20, 2018

Anticipated Primary Completion Date :

Sep 20, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in The Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q) score between groups over time [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

Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score [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.
Changes in The Hamilton Rating Scale for Anxiety (HAM-A) [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.
Changes in frequency of Syncope [Baseline, week 2, 4, 8]
A risk factor of sudden death
Changes in frequency of Arrhythmia [Baseline, week 2, 4, 8]
A risk factor of sudden death
Changes in Generalized Anxiety Disorder (GAD) -7 [Baseline, week 2, 4, 8]
A scale to test the severity of anxiety
Changes in Patient Health Questionnaire (PHQ) -9 [Baseline, week 2, 4, 8]
A scale to test the severity of depression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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.