An interventional study of Health Communication and Health communication in Depression - Major Depressive Disorder, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Supportive care
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:
Researchers will compare an intervention group (older adult and caregiver pairs who receive the education program) to a control group (pairs who receive standard community health care).
Participants in the intervention group will:
Study Design and Procedure:
This prospective controlled study will enroll 200 dyadic pairs (older adult aged 60+ and their primary caregiver) in the intervention arm, alongside a matched control group receiving routine community health care.
Participants in the intervention arm will attend 5 structured group education sessions (45-60 minutes per session), held over consecutive weeks. The curriculum covers:
Session 1 (Early Recognition \& Screening): Identifying early signs and symptoms of depression, understanding its physical and emotional impacts, and learning basic screening tools.
Session 2 (Sleep Hygiene): Understanding the link between sleep and mental health, and adopting practical sleep hygiene strategies.
Session 3 (Nutrition \& Physical Activity): Nutritional guidelines for mental well-being and introducing gentle, age-appropriate physical exercises.
Session 4 (Stress Management \& Social Support): Practicing stress-reduction techniques and linking dyads to local community resources and support systems.
Session 5 (Caregiver Support \& Q\&A): Interactive group discussion, practical coping strategies for caregivers, and screening caregivers for symptoms of depression, anxiety, and stress.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 550 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 121 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Older Adults
Inclusion Criteria for Primary Caregivers
Exclusion Criteria for Older Adults
Exclusion Criteria for Primary Caregivers
Casual care
Other: Health Communication
Casual care
Other: Health communication
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.
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. Session 5: Caregiver Support, Coping Skills, and Q\&A Dedicated to interactive Q\&A, practical coping strategies for care
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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 6 months after the intervention
Proportion of Older Adults With Depressive Symptoms at 6 Months Based on the Geriatric Depression Scale (30-item)
Depressive symptoms will be assessed using the Geriatric Depression Scale (30-item version; GDS-30), which 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 is the proportion of older adults whose GDS-30 score meets the prespecified threshold for depressive symptoms at 6 months after the intervention. The prespecified cutoff will be applied according to the study protocol.
Time frame: 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
Depressive symptoms among primary caregivers will be measured using the Depression Anxiety Stress Scales (21-item version; DASS-21), depression subscale. The depression subscale consists of 7 items. The raw subscale score ranges from 0 to 21, with higher scores indicating greater depressive symptoms and a worse outcome. The outcome will be expressed as the change in the depression subscale score from baseline to 6 months after the intervention.
Time frame: 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
Anxiety symptoms among primary caregivers will be measured using the Depression Anxiety Stress Scales (21-item version; DASS-21), anxiety subscale. The anxiety subscale consists of 7 items. The raw subscale score ranges from 0 to 21, with higher scores indicating greater anxiety symptoms and a worse outcome. The outcome will be expressed as the change in the anxiety subscale score from baseline to 6 months after the intervention.
Time frame: 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
Stress symptoms among primary caregivers will be measured using the Depression Anxiety Stress Scales (21-item version; DASS-21), stress subscale. The stress subscale consists of 7 items. The raw subscale score ranges from 0 to 21, with higher scores indicating greater stress symptoms and a worse outcome. The outcome will be expressed as the change in the stress subscale score from baseline to 6 months after the intervention.
Time frame: From baseline to 6 months after the intervention
Change From Baseline in Knowledge, Attitudes, and Practices Regarding Depression at 6 Months
Knowledge, attitudes, and practices regarding depression will be assessed using the study-specific Knowledge, Attitudes, and Practices (KAP) questionnaire. The questionnaire comprises separate knowledge, attitude, and practice domains. Domain scores and the total KAP score will be calculated according to the prespecified scoring algorithm. The possible score range is \[0-30\], with higher scores indicating better knowledge, more favorable attitudes, and healthier practices regarding depression. The outcome will be expressed as the change from baseline to 6 months after the intervention.
Time frame: From baseline to 6 months after the intervention
Participant Satisfaction With the Health Education Communication Program at 6 Months
Participant satisfaction with the health education communication program will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 consists of 8 items, with a total score ranging from 8 to 32 points. Higher scores indicate greater satisfaction with the program and represent a better outcome.
Time frame: Immediately after completion of the intervention
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 18 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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