Psycho-behavioral Intervention for Depression in Chronic Heart Failure

Effect of Psycho-behavioral Intervention on the Depression, Cardiac Function and Quality of Life in Older Adults With Chronic Heart Failure

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Psycho-behavioral intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huali Wang, PhD; Phone Number: +86 010-82801983; Email: huali_wang@bjmu.edu.cn
• Study Contact Backup: Name: Ying Zhang; Email: zhangying0603@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yun Zhu
    • Principal Investigator: Yun Zhu
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University
    • Contact: Jianhua He, MD
    • Principal Investigator: Jianhua He, MD
    • Sub-Investigator: Jin Yi, MD
    • Sub-Investigator: Yulan Liang
    • Sub-Investigator: Na Zhang, MD
  • Beijing, China
    • Recruiting
    • Beijing Chaoyang Hospital, Capital Medical University
    • Contact: Yongdong Hu
    • Principal Investigator: Yongdong Hu
  • Beijing, China
    • Recruiting
    • Beijing Chaoyang Third Hospital
    • Contact: Wanxin Ma
  • Beijing, China
    • Recruiting
    • Beijing Fengtai Tieying Hospital
    • Contact: Peiyun Sun
    • Principal Investigator: Peiyun Sun
    • Sub-Investigator: Ning Li
  • Beijing, China
    • Recruiting
    • Beijing Tiancun Community Health Center
    • Contact: Qingling Yang
    • Principal Investigator: Qingling Yang
    • Sub-Investigator: Chong Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional group; Subjects receive guided psycho-behavioral intervention once a week for 8 weeks. After 8 weeks, the subjects will receive monthly psychological counseling for 7 months.	Behavioral: Psycho-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.
NO_INTERVENTION: control group; Subjects will receive usual care and be contacted as same frequent as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version	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.	between baseline and week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16 Item Quick Inventory of Depressive Symptomatology Self-Report Version	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.	between baseline and week 1, 2, 4, 8, 24 and 36
17-Item Hamilton Rating Scale for Depression	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).	between baseline and week 4, 8, 12, 24 and 36
Beck Depression Inventory II	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.	between baseline and week 1, 2, 4, 8, 12, 24 and 36
Geriatric Depression Inventory-Self-Report	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.	between baseline and week 4, 8, 12, 24 and 36
amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)	change of NT-ProBNP level	between baseline and week 12, and between baseline and week 36
cardiac function	change of ejection fraction as measured with ultrasound cardiogram	between baseline and week 12, and between baseline and week 36
Minnesota living with heart failure questionnaire	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.	between baseline and week 4, 8, 12, 24 and 36

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Huali Wang, PhD, Peking University Institute of Mental Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ANTICIPATED): December 30, 2019
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (ACTUAL): July 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Mood Disorders; Heart Failure; Depression; Depressive Disorder
• Other Study ID Numbers: 2016-1-4117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the results of primary outcome are published, the individual participant data will only be shared anonymously based on request by email to study PI. The team using data should work with the study PI's team on data analysis and publications. The host project should be acknowledged in any submitted working paper, conference presentations and publications.
• IPD Sharing Time Frame: After the results of primary outcome are published. The data will be available for 2 years.
• IPD Sharing Access Criteria: Those who are interested in the study should submit a synopsis of research plan for administrative approval by the study committee. Once the data sharing plan is approved by the study committee, the researcher should submit a IRB approval from host institution. When the IRB approval is received, the study committee will ask the data manager to transfer the data for further analysis.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No