Depressive Symptoms, Generalized Anxiety, or Psychological Stress
Conditions
Brief summary
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.
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.
Interventions
BEHAVIORALCaregiver 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.
BEHAVIORALUsual 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
Sponsors
Brigham and Women's Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants (family caregivers and care recipients), providers (CMs and CCGs), outcome assessors, and data analysts will be blinded to group assignment. Blinding is achieved through cluster randomization by subdistrict, with providers trained and certified to deliver only one protocol based on their assigned cluster. Both arms receive home visits at the same frequency, maintaining participant blinding. Cross-cluster communication is discouraged through training and geographic separation. Only the unblinded study coordinator implementing randomization has access to allocation; this individual has no role in outcome assessment or primary data analysis.
Intervention model description
The R33 phase of the study will employ a two-arm, parallel-group randomized controlled trial (RCT) to evaluate the effectiveness of the CAMMA intervention in reducing psychological distress among family caregivers of adults with chronic conditions in Thailand. Eligible family caregivers will be randomized in a 1:1 ratio to either the CAMMA intervention arm or an active control condition. The study is designed to assess outcomes longitudinally at baseline, post-intervention, and follow-up, allowing examination of both short-term and sustained intervention effects.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | 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) |
| Anxiety Symptoms | 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) |
| Perceived Stress | 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) |
Countries
Thailand
Contacts
CONTACTHongtu Chen, PhD
Outcome results
None listed