Mobile Application for Early Detection and Intervention to Reduce Psychological Distress in Informal Family Caregivers of Community-dwelling Adults With Chronic Disorders in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Depressive Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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);
- •Access to a mobile device with internet access
排除标准
- •Caregiver who refuses to provide informed consent
研究组 & 干预措施
Intervention condition
Digital CAMMA intervention
干预措施: Caregiver Mental Health Mobile Application (CAMMA) Intervention (Behavioral)
Control condition
Enhanced usual care
干预措施: Usual Care Group (Behavioral)
结局指标
主要结局
Depressive Symptoms
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点
研究者
Hongtu Chen
Research Scientist
Brigham and Women's Hospital