Clinical trial NCT03233451: Psycho-behavioral Intervention for Depression in Chronic Heart Failure
Official title: Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 236
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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 -

Primary outcomes:
measure: 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
timeFrame: between baseline and week 12
Secondary outcomes:
measure: 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version
timeFrame: between baseline and week 1, 2, 4, 8, 24 and 36
measure: 17-Item Hamilton Rating Scale for Depression
timeFrame: between baseline and week 4, 8, 12, 24 and 36
measure: Beck Depression Inventory II
timeFrame: between baseline and week 1, 2, 4, 8, 12, 24 and 36
measure: Geriatric Depression Inventory-Self-Report
timeFrame: between baseline and week 4, 8, 12, 24 and 36
measure: amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)
timeFrame: between baseline and week 12, and between baseline and week 36
measure: cardiac function
timeFrame: between baseline and week 12, and between baseline and week 36
measure: Minnesota living with heart failure questionnaire
timeFrame: between baseline and week 4, 8, 12, 24 and 36
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Chaoyang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Chaoyang Third Hospital
city: Beijing
country: China
facility: Beijing Fengtai Tieying Hospital
city: Beijing
country: China
facility: Beijing Tiancun Community Health Center
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Institute of Mental Health
name: Huali Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Lv X, Jiang W, Zhu Y, Xu W, Hu Y, Ma W, Sun P, Yang Q, Liang Y, Ren F, Yu X, Wang H. Effectiveness of a telephone-delivered psycho-behavioural intervention on depression in elderly with chronic heart failure: rationale and design of a randomized controlled trial. BMC Psychiatry. 2019 May 27;19(1):161. doi: 10.1186/s12888-019-2135-2.