Hypertrophic CardiomyopathyNCT03706001
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
A study testing Psychotherapy in people with Hypertrophic Cardiomyopathy and Depression, run by Xijing Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy, Depression, Anxiety
- What is being tested?
- Psychotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as hypertrophic cardiomyopathy;
- Diagnosed as depression;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy, Depression, Anxiety, Psychotherapy
- Being tested
- Psychotherapy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyOther
Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants will receive psychotherapy for once a week. Receives: Other: Psychotherapy |
| Control Arm | No intervention | Participants will not receive any treatment for depression. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 2, 4, 8
Secondary outcomes (6)
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.
Measured: Baseline, week 2, 4, 8
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.
Measured: Baseline, week 2, 4, 8
Changes in frequency of Syncope
A risk factor of sudden death
Measured: Baseline, week 2, 4, 8
Changes in frequency of Arrhythmia
A risk factor of sudden death
Measured: Baseline, week 2, 4, 8
Changes in Generalized Anxiety Disorder (GAD) -7
A scale to test the severity of anxiety
Measured: Baseline, week 2, 4, 8
Changes in Patient Health Questionnaire (PHQ) -9
A scale to test the severity of depression
Measured: Baseline, week 2, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start20 Oct 2018 (estimated)
- Primary completion20 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liwen Liu, Doctor, Study director, Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.Bo Wang, Master, Study director, Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.Huaning Wang, Doctor, Study chair, Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.Wenjun Wu, Master, Principal investigator, Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706001
- Sponsor's protocol ID
- KY20182033-1
- Status last verified
- Sep 2018
- First submitted
- 29 Sep 2018
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigator have not decided whether or not to share the data.
Publications
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.
PubMed 28235781Morgan 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.
PubMed 18164940Igoumenou 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.
PubMed 27326027
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
- ClinicalTrials.gov ID
- NCT03706001
- Acronym / sponsor ID
- KY20182033-1
- Conditions
- Hypertrophic Cardiomyopathy, Depression, Anxiety, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 20 Oct 2018 (estimated)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: PsychotherapyParticipants will receive psychotherapy for once a week. |
| Control Arm | No intervention | –Participants will not receive any treatment for depression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed as hypertrophic cardiomyopathy;
- Diagnosed as depression;
Key exclusion criteria (9 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapyPsychotherapy has gained increasing acceptance as a major treatment option for mood disorders. | Other | Experimental Arm |
Primary outcome
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.
6 secondary outcomes
Changes in The Hamilton Depression Rating Scale17 (HAM-D17) score
Time frame: Baseline, week 2, 4, 8
Changes in The Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: Baseline, week 2, 4, 8
Changes in frequency of Syncope
Time frame: Baseline, week 2, 4, 8
Changes in frequency of Arrhythmia
Time frame: Baseline, week 2, 4, 8
Changes in Generalized Anxiety Disorder (GAD) -7
Time frame: Baseline, week 2, 4, 8
Changes in Patient Health Questionnaire (PHQ) -9
Time frame: Baseline, week 2, 4, 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Background: PubMed 28235781Dossat 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 publication: PubMed 18164940Morgan 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 publication: PubMed 27326027Igoumenou 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.
- Individual participant dataSharing planned: Undecided. The investigator have not decided whether or not to share the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liwen Liu, Doctor study director
Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Bo Wang, Master study director
Department of Ultrasonography, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Huaning Wang, Doctor study chair
Department of Psychiatry, Xijing Hospital, The Air Force Medical University, 127# Changle Road, Xi'an, 710032, China.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Hypertrophic Cardiomyopathy and Depression, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huaning Wang, Doctor ((+86)13609161341, 13609161341@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706001, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.