Depression - Major Depressive DisorderDepressionNCT07877571
Effectiveness of Health Communication on Depression Elderly in Ho Chi Minh City
A study testing Health Communication in people with Depression - Major Depressive Disorder, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Health Communication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- Aged 18 years or older, with full legal capacity, and capable of hearing, understanding, and self-completing the survey questionnaire.
- Identified as the primary caregiver of an older adult who has already met the inclusion criteria and agreed to participate in the study.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, Cho Lon, 700000
Diep Le Tuan, Psychiatrist
About this study
Official title: Hiệu quả chương trình truyền thông giáo dục sức khoẻ về trầm cảm người Cao tuổi tại Thành phố Hồ Chí Minh
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:
Read more
- Does the health education program improve knowledge, attitudes, and practice regarding depression among older adults and their primary caregivers?
- Does the program reduce depression scores (measured by GDS-30) and improve quality of life in older adults compared to standard care?
- Does the program help lower caregiving burden and stress among primary caregivers?
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:
- 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.
Read the detailed description
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.
- Conditions
- Depression - Major Depressive Disorder
- Being tested
- Health Communication
- Keywords
- elderly, depression, caregiver
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CommunicationOther
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.
Health communicationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Elderly over 60 years old | Other | Casual care Receives: Other: Health Communication |
| Main caregiver | Other | Casual care Receives: Other: Health communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diep Le Tuan, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877571
- Sponsor's protocol ID
- 1992/ĐHYD-HĐĐĐ
- Acronym
- Depression
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hiệu quả chương trình truyền thông giáo dục sức khoẻ về trầm cảm người Cao tuổi tại Thành phố Hồ Chí Minh
- ClinicalTrials.gov ID
- NCT07877571
- Acronym / sponsor ID
- Depression / 1992/ĐHYD-HĐĐĐ
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- elderly, depression, caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the health education program improve knowledge, attitudes, and practice regarding depression among older adults and their primary caregivers?
- Does the program reduce depression scores (measured by GDS-30) and improve quality of life in older adults compared to standard care?
- Does the program help lower caregiving burden and stress among primary caregivers?
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:
- 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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly over 60 years old | Other | Other: Health CommunicationCasual care |
| Main caregiver | Other | Other: Health communicationCasual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CommunicationThe 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. | Other | Elderly over 60 years old |
| Health communicationThe 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 | Other | Main caregiver |
Primary outcome
Change From Baseline in Geriatric Depression Scale (30-item) Total Score at 3-6 Months
Time frame: From baseline to 6 months after the intervention
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.
Change From Baseline in Zarit Burden Interview (22-item) Total Score at 6 Months
Time frame: From baseline to 6 months after the intervention
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.
Change From Baseline in World Health Organization Quality of Life-BREF Scores at Post-Intervention
Time frame: From baseline to 6 months after the 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.
4 secondary outcomes
Proportion of Older Adults With Depressive Symptoms at 6 Months Based on the Geriatric Depression Scale (30-item)
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
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
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
Time frame: From baseline to 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Communication in people with Depression - Major Depressive Disorder, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diep Le Tuan, Psychiatrist (+84 775525532, letuan.vatc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Geriatric Depression Scale (30-item) Total Score at 3-6 Months (time frame: From baseline to 6 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.