Overview
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.
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.
Eligibility
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.
