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Mobile Intervention for Mental Health of Family Caregivers in Thailand

NCT ID: NCT06722287

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2028-07-31

Brief Summary

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The goal of the R21 project is to develop a culturally informed Caregiver Mental Health Mobile Application program that will promote early detection of mental health problems and deliver an evidence-based self-care intervention for family caregivers providing care to adults with chronic disease in Thailand.

Detailed Description

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The goal of the 2-year R21 project is to develop a culturally informed Caregiver Mental Health Mobile Application (hereafter referred to as CAMMA) program that will deliver an evidence-based intervention to reduce mental health problems in family caregivers of adults with chronic disorders in Thailand. Specific aims include: 1) Conducting qualitative research on family caregivers of persons with chronic disorders, focusing on their experience with mental health problems, caregiving practice, coping mechanisms, and socio-technological barriers to technology acceptance and use; 2) Develop a mobile application for the delivery of the CAMMA intervention; and 3) Conduct a formative evaluation of the CAMMA Intervention Components to ensure acceptability and usability of individual intervention components.

Conditions

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Depressive Symptoms, Generalized Anxiety, or Psychological Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

20 family caregivers will be asked to utilize each of the five CAMMA intervention components over a five-week period (i.e., about one component per week). At the initial home visit, research staff will set up network configuration (e.g., WiFi) and demonstrate step-by-step guidelines for using the features on the smartphone. The caregiver will then be asked to perform these tasks, to ensure that they have understood the instructions.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CAMMA Intervention

Mobile application intervention that provides family caregivers with self-care tools, care management tools, and online support group

Group Type EXPERIMENTAL

Caregiver Mental Health Mobile Application Intervention

Intervention Type BEHAVIORAL

The mobile application includes self-care tools, caregiving management tools, and online support groups

Interventions

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Caregiver Mental Health Mobile Application Intervention

The mobile application includes self-care tools, caregiving management tools, and online support groups

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* adult (age 18 +) family caregiver (CG)
* has a minimum of 4 months of experience as a caregiver and provides at least 4 hours a day of care to the care recipient (CR);
* screen positive on depressive symptoms (score above 5 on PHQ-9), or generalized anxiety (score above 3 on GAD-2), or stress measured with Perceive Stress Scale (score above 6 on PPS-4)
* Access to a mobile device with internet access

Exclusion Criteria

* Caregiver who refuses to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongtu Chen

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ministry of Public Health

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Hongtu Chen, PhD

Role: CONTACT

Phone: 617 459 5072

Email: [email protected]

Facility Contacts

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Komatra Chuengsatiansup, MD

Role: primary

Siranee Sihapark, PhD

Role: backup

Other Identifiers

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5R21MH131043-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P001212

Identifier Type: -

Identifier Source: org_study_id