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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
400
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.
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
Ministry of Public Health
Bangkok, Thailand
RECRUITINGDepressive Symptoms
Measured using the Patient Health Questionnaire-9 (PHQ-9)
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)
Anxiety Symptoms
Measured using the Generalized Anxiety Disorder-7 (GAD-7)
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)
Perceived Stress
Measured using the Thai version of the Perceived Stress Scale (T-PSS-10)
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)
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