Hiệu quả chương trình truyền thông giáo dục sức khoẻ về trầm cảm người Cao tuổi tại Thành phố Hồ Chí Minh
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All trials for Depression - Major Depressive Disorder All trials of Health Communication All trials of Health communication
-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. Does the health education program improve knowledge, attitudes, and practice regarding depression among older adults and their primary caregivers?
2. Does the program reduce depression scores (measured by GDS-30) and improve quality of life in older adults compared to standard care?
3. 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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Elderly over 60 years old | Other | Other: Health Communication | Casual care |
| Main caregiver | Other | Other: Health communication | Casual care |
- 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.
- 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.
Session 5: Caregiver Support, Coping Skills, and Q\&A Dedicated to interactive Q\&A, practical coping strategies for care
+Outcome measures
Primary outcomes
- Change From Baseline in Geriatric Depression Scale (30-item) Total Score at 3-6 Months [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 [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 [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.
Secondary outcomes
- 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]: 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.
- 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]: 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.
- 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]: 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.
- 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]: 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.
Other outcomes
- Change From Baseline in Knowledge, Attitudes, and Practices Regarding Depression at 6 Months [From baseline to 6 months after the intervention]: 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.
- Participant Satisfaction With the Health Education Communication Program at 6 Months [Immediately after completion of the intervention]: 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.
+Eligibility
Sex: All, ages: 60 Years to any, accepts healthy volunteers
Inclusion Criteria for Older Adults
* 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).
Inclusion Criteria for Primary Caregivers
* 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.
* 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.
Exclusion Criteria for Older Adults
* 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.
Exclusion Criteria for Primary Caregivers
* 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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City, Cho Lon | Vietnam | Recruiting |