Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT03233451
Eligibility Criteria:
Inclusion Criteria:
1. between 60 -85 years old.
2. male or female.
3. Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
4. The subject is diagnosed with chronic heart failure according to their history, symptoms, signs, and adjuvant examinations (eg,echocardiography), in line with the diagnostic criteria for chronic heart failure presented in the China Heart Failure Diagnosis and Treatment Guidelines, with NYHA (New York Heart Association) grade II-III.
5. Reading and writing competency for completing the rating scales.
6. Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.
Exclusion Criteria:
1. Currently taking antidepressant drugs, and drug dose is unstable.
2. With is a serious risk of suicide, suicide attempts and suicidal behavior (HAMD17 score of 30 or above, or suicide subscale score of 3 and aboveļ¼or suicide subscale score of MINI of 6 or above).
3. Intact cognitive function with CSI-D score of less than 7.
4. Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
5. Planned heart surgery within 9 months.
6. Unable to comply with psychological intervention due to serious physical conditions -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT03233451
Study Brief:
Protocol Section:
NCT03233451