Psycho-behavioral Intervention for Depression in Chronic Heart Failure

NCT03233451 | Unknown DMC

• 1 other identifier: 2016-1-4117
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 16 Item Quick Inventory of Depressive Symptomatology Self-Report Version

  between baseline and week 1, 2, 4, 8, 24 and 36

• 17-Item Hamilton Rating Scale for Depression

  between baseline and week 4, 8, 12, 24 and 36

• Beck Depression Inventory II

  between baseline and week 1, 2, 4, 8, 12, 24 and 36

• Geriatric Depression Inventory-Self-Report

  between baseline and week 4, 8, 12, 24 and 36

• amino-terminal fragment of pro-B-type natriuretic peptide (NT-ProBNP)

  between baseline and week 12, and between baseline and week 36

Study Arms (2)

Interventional group

EXPERIMENTAL

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

control group

NO INTERVENTION

Subjects will receive usual care and be contacted as same frequent as the intervention group.

Interventions

Psycho-behavioral intervention BEHAVIORAL

The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.

Interventional group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 60 -85 years old.
• male or female.
• Diagnosis with depression as measured with PHQ-9 score of 5 and greater;
• 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.
• Reading and writing competency for completing the rating scales.
• Sufficient physical condition, hearing and vision to ensure the completion of psychological behavior intervention.

You may not qualify if:

• Currently taking antidepressant drugs, and drug dose is unstable.
• 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).
• Intact cognitive function with CSI-D score of less than 7.
• Having other major mental disorders, including Alzheimer's disease, schizophrenia, schizoaffective psychiatric disorders, delusional disorders, undefined psychotic disorders, substance and alcohol abuse
• Planned heart surgery within 9 months.
• Unable to comply with psychological intervention due to serious physical conditions -

Sponsors & Collaborators

• Peking University: lead

Study Sites (6)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Chaoyang Third Hospital

Beijing, China

RECRUITING

Beijing Fengtai Tieying Hospital

Beijing, China

RECRUITING

Beijing Tiancun Community Health Center

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31132996 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Huali Wang, PhD

  Peking University Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huali Wang, PhD

CONTACT

+86 010-82801983; huali_wang@bjmu.edu.cn

Ying Zhang

CONTACT

zhangying0603@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 28, 2017
• Study Start: August 1, 2017
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2020
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: After the results of primary outcome are published. The data will be available for 2 years.
• 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.

Locations

CN (6)