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| ID | Type | Description | Link |
|---|---|---|---|
| 4R33MH131043-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention condition | Experimental | Digital CAMMA intervention |
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| Control condition | Active Comparator | Enhanced usual care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver Mental Health Mobile Application (CAMMA) Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | 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 | 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongtu Chen, PhD | Contact | 617 459 5072 | hchen@bwh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Public Health | Recruiting | Bangkok | Thailand |
We need to decide on specific procedures and types of researchers for sharing the IPD.
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| ID | Term |
|---|---|
| D003863 | Depression |
| D000098647 | Generalized Anxiety Disorder |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
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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.
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| Usual Care Group | Behavioral | 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 |
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