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NCT Number: NCT06722287

Mobile Intervention for Mental Health of Family Caregivers 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.

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Key information

Conditions

Depressive Symptoms, Generalized Anxiety, or Psychological Stress Anxiety Disorders Behavior Behavioral Symptoms Depression Generalized Anxiety Disorder Mental Disorders Stress, Psychological

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Caregiver who refuses to provide informed consent

Treatment and study plan

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.

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hongtu Chen, PhD

CONTACT

[email protected]

617 459 5072

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Mobile Application for Early Detection and Intervention to Reduce Psychological Distress in Informal Family Caregivers of Community-dwelling Adults With Chronic Disorders in Thailand

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 9, 2024
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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