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Depression, AnxietyNCT06700551

Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam

A study testing Psychoeducation in people with Depression, Anxiety and Stress, run by Nguyen Tran To Tran at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to determine whether a mobile phone-based psychoeducational intervention can reduce stress among caregivers of individuals with dementia in Vietnam. The primary research question is: Does the intervention reduce levels of depression, anxiety, and stress among participants? The secondary… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression, Anxiety, Stress
What is being tested?
Psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteVietnam
Study dates
26 Oct 2024to 5 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary Caregiver Requirement: Participants must have been the primary caregivers of poeple with dementia for at least the past 6 months and plan to continue in this role for the next 6 months of the intervention. Patients with demeentia criteria: Patients must have been diagnosed with dementia for at least 6 months and reside within the community.
  • Language and Education Requirement: Participants must be able to read and understand Vietnamese (with at least a primary education level) and be willing to participate in the study.
  • Smartphone Requirement: Participants must own a smartphone with the Zalo app or be willing to install it (with a brief training session provided for new users).
  • Age Requirement: Participants must be aged 18 years or older.

Who cannot join

  • Having any acute diseases or cognitive impairment (screening by Mini-Cog) or
  • Having vision or hearing impairment

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Nhan Dan Gia Dinh Hospital

    Ho Chi Minh City, Ho Chi Minh City, 70000

Other trials in Vietnam

About this study

Official title: Evaluating the Efficacy of Mobile-Phone-Based Psychoeducation Intervention on Depression, Anxiety, and Stress in Dementia Caregivers

The goal of this study is to determine whether a mobile phone-based psychoeducational intervention can reduce stress among caregivers of individuals with dementia in Vietnam. The primary research question is: Does the intervention reduce levels of depression, anxiety, and stress among participants? The secondary research question is: Does the intervention increase caregivers' knowledge about dementia, enhance social support, or reduce caregiver burden?

Read the detailed description

The study consists of two groups: an intervention group and a control group. Participants in the intervention group will receive psychoeducational content through the Zalo app on their mobile phones. Weekly, they will be provided with a topic related to dementia care, such as daily caregiving, fall prevention, pressure injury prevention and care, self-care, and coping as a caregiver. Levels of depression, anxiety, and stress will be assessed both before and after the intervention. In the control group, participants will continue receiving standard care.

Being tested
Psychoeducation
Keywords
dementia, caregiver, depression, anxiety, stress, intervention, psychoeducation, mobile-phone
Medical subject headings
Depression, Anxiety Disorders, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsychoeducationOther

    Each week, the investigator will send participants one topic through the chat function on the Zalo app. Before receiving the topic, participants will vote on which topic they would like to learn about. The topics will be presented as videos and will cover the following seven areas: providing everyday care, being a caregiver, self-care, knowledge about dementia, fall prevention, pressure injury prevention and care, and managing behavior changes.They may ask questions related to providing dementia care or share their feelings via the chat on the Zalo app.

Study groups in NCT06700551
Study groupRoleWhat they receive
Psychoeducation Intervention GroupExperimentalIn the intervention group, participants will receive interventions through the Zalo app on their mobile phones. Weekly, the investigator will send a topic for participants to learn about. Participants will have the opportunity to ask questions and share their feelings or experiences through the Zalo app.
Receives: Other: Psychoeducation
Control groupNo interventionParticipants will receive usual care and will not receive any intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression, anxiety and stress levels

    Levels of depression, anxiety, and stress will be assessed using the Depression, Anxiety, and Stress Scale (DASS-21), which includes three subscales. Each subscale has a scoring range from 0 to 42, resulting in a total possible score between 0 and 126. Higher scores indicate more severe symptoms and worse outcomes.

    Measured: The evaluation period will span from enrollment to the end of the 7-week intervention and continue through three months post-intervention. Assessments will be conducted at three key time points: baseline (prior to the intervention), immediately after the

Secondary outcomes (3)

  1. Demetia knowledge

    Participants' demntia knowledge will be assessed using a questionnaire adapted from the Northern Ireland Life and Times Survey, consisting of 7 items. The total score ranges from 0 to 7, with higher scores indicating better knowledge and understanding of dementia.

    Measured: The evaluation period will extend over 9 months. Assessments will be conducted at three time points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.

  2. Caregiver burden

    Participants will be assessed using the Zarit 4-Item Burden Interview, which consists of four items. Each item is rated on a scale of 1 to 4, with higher scores indicating a greater sense of caregiver burden.

    Measured: The evaluation period will extend over 9 months. Assessments will be conducted at three key time points: baseline (before the intervention), immediately post-intervention, and three months post- intervention.

  3. Percieved social support

    Participants will be assessed using the Multidimensional Perceived Social Support Scale (MSPSS), which consists of 12 items. Each item is rated on a 7-point Likert scale, ranging from 1 (very strongly disagree) to 7 (very strongly agree). The total score ranges from 12 to 84, with higher scores indicating greater levels of perceived social support.

    Measured: The evaluation will span 9 months, with assessments conducted at three key points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2024
  2. Study start26 Oct 2024
  3. Primary completion5 Jul 2025
  4. Study completion5 Jul 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Psychoeducation
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06700551
Sponsor's protocol ID
557-HDDD-DHYD
Status last verified
Aug 2025
First submitted
20 Oct 2024
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To ensure participant confidentiality, study results will only be shared upon the request and with the explicit agreement of the principal investigator.

Publications

  • Bruwer B, Emsley R, Kidd M, Lochner C, Seedat S. Psychometric properties of the Multidimensional Scale of Perceived Social Support in youth. Compr Psychiatry. 2008 Mar-Apr;49(2):195-201. doi: 10.1016/j.comppsych.2007.09.002. Epub 2007 Dec 21.

    PubMed 18243894

  • McParland P, Devine P, Innes A, Gayle V. Dementia knowledge and attitudes of the general public in Northern Ireland: an analysis of national survey data. Int Psychogeriatr. 2012 Oct;24(10):1600-13. doi: 10.1017/S1041610212000658. Epub 2012 May 17.

    PubMed 22591515

  • Nguyen TTT, Vu LDT, Nguyen TC, Truong KT, Thai TT, Than THN, Nguyen HT. Mobile App Psychoeducation for Dementia Caregivers In Vietnam: A Randomized Controlled Trial. J Multidiscip Healthc. 2025 Oct 23;18:6871-6885. doi: 10.2147/JMDH.S557573. eCollection 2025.

    PubMed 41158517

Questions about this trial

What is this clinical trial studying?

A study testing Psychoeducation in people with Depression, Anxiety and Stress, run by Nguyen Tran To Tran 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Aug 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression, anxiety and stress levels (time frame: The evaluation period will span from enrollment to the end of the 7-week intervention and continue through three months post-intervention. Assessments will be conducted at three key time points: baseline (prior to the intervention), immediately after the). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06700551, which also lists 3 linked publications.

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 3 Aug 2025.

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