Depression
Conditions
Brief summary
The study aims to explore the effectiveness of psycho-behavioral intervention on depressive symptoms among older adults with chronic heart failure. Meanwhile, the effect on cardiac function and quality of life will also be explored.
Detailed description
Depression has been one of the emerging health concerns for older adults, especially for those with chronic heart failure (CHF). It was about 4-5 times more prevalent among patients with CHF than healthy population and independently associated with poor outcome of CHF. As suggested in the clinical management guideline of CHF, it is imperative to create integrative intervention for older adults with CHF, including timely detection and intervention, and ultimately improving the clinical outcome of CHF. However, the approach appropriate for depression intervention among Chinese older adults has yet been developed. This study aims to explore the effectiveness of psycho-behavioral intervention on depression associated with chronic heart failure in old age.
Interventions
BEHAVIORALPsycho-behavioral intervention
The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
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 above，or 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version | between baseline and week 12 | The primary outcome measure is the response rate of depression from baseline to week 12. The response rate was defined as a 50% or greater score reduction on 16 Item Quick Inventory of Depressive Symptomatology-Self-Report. The total score ranges from 0 to 27, with higher scores indicating more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 17-Item Hamilton Rating Scale for Depression | between baseline and week 4, 8, 12, 24 and 36 | The severity of depressive symptoms was measured with 17-Item Hamilton Rating Scale for Depression. The 17-item Hamilton Depression Rating Scale produces a total score ranging from 0 (not at all depressed) to 52 (severely depressed). |
| Beck Depression Inventory II | between baseline and week 1, 2, 4, 8, 12, 24 and 36 | The Beck Depression Inventory II assesses the severity of depression and produces a total score ranging from 0 to 63, with higher scores indicating more severe symptoms. |
| Geriatric Depression Inventory-Self-Report | between baseline and week 4, 8, 12, 24 and 36 | The Geriatric Depression Inventory-Self-Report assesses the severity of depression and produces a total score ranging from 0 to 12, with higher scores indicating more severe symptoms. |
| 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version | between baseline and week 1, 2, 4, 8, 24 and 36 | The severity of depressive symptoms was measured with the 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version. The score ranges from 0 to 27, with higher scores indicating more severe symptoms. |
| cardiac function | between baseline and week 12, and between baseline and week 36 | change of ejection fraction as measured with ultrasound cardiogram |
| Minnesota living with heart failure questionnaire | between baseline and week 4, 8, 12, 24 and 36 | The health-related quality of life was measured by Minnesota Living with Heart Failure Questionnaire.The total score ranges from 0 to 105, with higher scores from best to worst health-related quality of life. |
| amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP) | between baseline and week 12, and between baseline and week 36 | change of NT-ProBNP level |
Countries
China
Contacts
Primary ContactHuali Wang, PhD
Backup ContactYing Zhang
Outcome results
None listed