Mobile Intervention for Mental Health of Family Caregivers in Thailand

Mobile Application for Early Detection and Intervention to Reduce Psychological Distress in Informal Family Caregivers of Community-dwelling Adults with Chronic Disorders in Thailand

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms, Generalized Anxiety, or Psychological Stress
• Intervention / Treatment: Behavioral: Caregiver Mental Health Mobile Application Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongtu Chen, PhD; Phone Number: 617 459 5072; Email: hchen@bwh.harvard.edu

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Ministry of Public Health
    • Contact: Komatra Chuengsatiansup, MD; Phone Number: +66 626016116; Email: loxlix@gmail.com
    • Contact: Siranee Sihapark, PhD; Phone Number: +66 810551215; Email: daosiam@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAMMA Intervention; Mobile application intervention that provides family caregivers with self-care tools, care management tools, and online support group	Behavioral: Caregiver Mental Health Mobile Application Intervention; The mobile application includes self-care tools, caregiving management tools, and online support groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Measured by the System Usability Scale	5 weeks of intervention
Acceptability	Measured by the User Experience Questionnaire	5 week of intervention

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Stress, Psychological
• Other Study ID Numbers: 2023P001212; 5R21MH131043-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We need to decide on specific procedures and types of researchers for sharing the IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No