Mobile Intervention for Mental Health of Family Caregivers in Thailand

NCT06722287 | Recruiting

• 2 other identifiers: 2023P0012124R33MH131043-03
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms, Generalized Anxiety, or Psychological Stress

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

Intervention condition

EXPERIMENTAL

Digital CAMMA intervention

Behavioral: Caregiver Mental Health Mobile Application (CAMMA) Intervention

Control condition

ACTIVE COMPARATOR

Enhanced usual care

Behavioral: Usual Care Group

Interventions

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.

Intervention condition

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

Control condition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Caregiver who refuses to provide informed consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ministry of Public Health

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Depression; Generalized Anxiety Disorder; Stress, Psychological

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Hongtu Chen, PhD

CONTACT

617 459 5072; hchen@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

TH (1)