Effectiveness of Health Communication on Depression Elderly in Ho Chi Minh City

NCT07877571 | Recruiting DMC

• 1 other identifier: 1992/ĐHYD-HĐĐĐ
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a community-based health education and communication program helps prevent and reduce depression in older adults living in Ho Chi Minh City. It will also evaluate how the program affects quality of life and caregiver stress. The main questions it aims to answer are:

• Attend 5 group education sessions (45-60 minutes each) covering early depression detection, sleep hygiene, nutrition, physical activity, stress management, and caregiver support.
• Complete questionnaires at the start and end of the program to measure depression symptoms, quality of life, caregiving burden, and health knowledge.

Conditions

Depression - Major Depressive Disorder

Keywords

elderly; depression; caregiver

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Geriatric Depression Scale (30-item) Total Score at 3-6 Months

  Depressive symptoms will be measured using the Geriatric Depression Scale (30-item version; GDS-30). The GDS-30 consists of 30 items with a total score ranging from 0 to 30. Higher scores indicate greater severity of depressive symptoms and a worse outcome. The outcome will be expressed as the change in GDS-30 total score from baseline to 6 months after the intervention. A lower or more negative change score indicates greater improvement in depressive symptoms.

  From baseline to 6 months after the intervention

• Change From Baseline in Zarit Burden Interview (22-item) Total Score at 6 Months

  Caregiver burden will be measured using the Zarit Burden Interview (22-item version; ZBI-22). The ZBI-22 consists of 22 items, with a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden and a worse outcome. The outcome will be expressed as the change in ZBI-22 total score from baseline to 6 months after the intervention. A lower or more negative change score indicates a reduction in caregiver burden.

  From baseline to 6 months after the intervention

• Change From Baseline in World Health Organization Quality of Life-BREF Scores at Post-Intervention

  Quality of life will be measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF; 26-item version). The total score will be calculated according to the prespecified scoring procedure for the instrument. Higher scores indicate better quality of life and a better outcome. The outcome will be assessed by comparing the change in WHOQOL-BREF total score from baseline to 6 months between the intervention and control groups.

  From baseline to 6 months after the intervention

Secondary Outcomes (4)

• Proportion of Older Adults With Depressive Symptoms at 6 Months Based on the Geriatric Depression Scale (30-item)

  From baseline to 6 months after the intervention

• Change From Baseline in Depression Subscale Score of the Depression Anxiety Stress Scales (21-item) at 6 Months

  From baseline to 6 months after the intervention

• Change From Baseline in Anxiety Subscale Score of the Depression Anxiety Stress Scales (21-item) at 6 Months

  From baseline to 6 months after the intervention

• Change From Baseline in Stress Subscale Score of the Depression Anxiety Stress Scales (21-item) at 6 Months

  From baseline to 6 months after the intervention

Other Outcomes (2)

• Change From Baseline in Knowledge, Attitudes, and Practices Regarding Depression at 6 Months

  From baseline to 6 months after the intervention

• Participant Satisfaction With the Health Education Communication Program at 6 Months

  Immediately after completion of the intervention

Study Arms (2)

Elderly over 60 years old

OTHER

Casual care

Other: Health Communication

Main caregiver

OTHER

Casual care

Other: Health communication

Interventions

Health communication OTHER

The intervention group older adult participating in a 5-session health education program (estimated 45-60 minutes per session), structured around the following key modules: Session 1: Early Identification and Screening of Depression Focuses on early recognition of depressive symptoms, the impacts of depression, and instruction on screening tools. Session 2: Sleep and Sleep Hygiene Addresses the role of sleep in mental health and evidence-based sleep hygiene techniques. Session 3: Nutrition and Physical Activity Covers the roles of nutrition and exercise in depression prevention, introducing tailored physical activities for older adults. Session 4: Stress Management and Social Support Integration Introduces stress-reduction exercises and techniques to connect with and leverage community and social support networks.

Elderly over 60 years old

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60 years or older.
• Currently residing in Ho Chi Minh City, with continuous residence in the locality for at least 6 months.
• Willing and agreeing to participate in the study (informed consent provided).
• Role: Serving as the primary person responsible for and/or providing the most support to the older adult in activities of daily living (ADLs) (e.g., eating, personal hygiene, mobility) and/or providing emotional support and healthcare management (e.g., medication adherence, accompanying to medical appointments).
• Duration: Having performed this caregiving role for at least 6 consecutive months (to ensure adequate observation time and caregiving burden experience).
• Frequency: Living in the same household with the older adult, or, if residing separately, having direct contact and providing care on most days of the week.
• Aged 18 years or older, with full legal capacity, and capable of hearing, understanding, and self-completing the survey questionnaire.
• Voluntarily agreeing to participate in the study after receiving a detailed explanation of the study objectives and signing the Informed Consent Form (ICF).
• Note: In cases where no family caregiver is identified during the survey phase, professional/paid caregivers (e.g., formal nurses or hired aides employed specifically for caregiving tasks without family ties to the older adult) will be considered.

You may not qualify if:

• Temporary residents or individuals absent from the study area during the study period.
• Individuals with severe cognitive impairment or lack of mental capacity to complete the questionnaire.
• Individuals with acute medical conditions in severe/critical stages, those diagnosed with other psychiatric disorders, or those uncooperative during the study process.
• Refusal to participate or lacking capacity to complete the interview due to severe cognitive impairment, dementia, or severe psychiatric disorders.
• Currently suffering from severe physical or mental health deterioration (e.g., undergoing emergency medical treatment, severe fever) that significantly impairs their ability to respond to the interview.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Cho Lon, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Health Communication

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Central Study Contacts

Diep Le Tuan, Psychiatrist

CONTACT

+84 775525532; letuan.vatc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mental Health Hospital, General and Planning department, Ho Chi Minh City, Vietnam

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: October 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 16, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)