Mobile Intervention for Mental Health of Family Caregivers in Thailand

July 20, 2026 updated by: Hongtu Chen, Brigham and Women's Hospital

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 primary objective of this study is to evaluate the effectiveness of the CAMMA intervention in reducing psychological distress among family caregivers of adults with chronic conditions in Thailand. Psychological distress is operationalized as depressive symptoms, anxiety symptoms, and perceived stress.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The R33 randomized controlled trial will test whether CAMMA leads to meaningful reductions in depressive symptoms, anxiety, and perceived stress among family caregivers, compared with an active control condition. Consistent with the underlying caregiving risk framework, the trial will also examine hypothesized mediators-including self-care skills, caregiving self-efficacy, caregiver burden, and engagement with intervention components-to clarify mechanisms of action.

By embedding the intervention within existing service delivery structures and engaging frontline care managers and community care givers as active participants, the R33 trial is designed to generate evidence that is both clinically meaningful and implementation-relevant. This approach responds directly to the need for scalable, sustainable strategies to support caregiver mental health in low- and middle-income country settings and provides a strong empirical foundation for future dissemination and scale-up.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adult (age 18 +) family caregiver (CG)
  2. 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);
  3. Access to a mobile device with internet access

Exclusion Criteria:

  • Caregiver who refuses to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention condition
Digital CAMMA intervention
Behavioral: Caregiver Mental Health Mobile Application (CAMMA) Intervention
12-week system-integrated digital intervention including caregiver-facing mental health self-monitoring tools, self-care and caregiving support modules, facilitated peer interaction, and standardized triage/referral workflows supported by Care Manager / Community Caregiver digital interfaces. Engagement prompts and monitoring dashboards are used to support sustained use.
Active Comparator: Control condition
Enhanced usual care
Behavioral: Usual Care Group
12-week enhanced usual care including general health education materials and facilitated group discussions; no access to CAMMA's caregiver mental health monitoring, caregiver-specific self-care module

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)
Measured using the Patient Health Questionnaire-9 (PHQ-9)
At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)
Anxiety Symptoms
Time Frame: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)
Measured using the Generalized Anxiety Disorder-7 (GAD-7)
At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)
Perceived Stress
Time Frame: At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)
Measured using the Thai version of the Perceived Stress Scale (T-PSS-10)
At baseline (during about 2 weeks after consent and prior to initiation of study condition procedures), post-intervention (at the conclusion of the 12-week intervention period), and follow-up (approximately 3 months after completion of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

April 30, 2028

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 (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P001212
  • 4R33MH131043-03 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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