Depressive Symptoms, Generalized Anxiety, or Psychological StressNCT06722287
Mobile Intervention for Mental Health of Family Caregivers in Thailand
A study testing Caregiver Mental Health Mobile Application (CAMMA) Intervention in people with Depressive Symptoms, Generalized Anxiety, or Psychological Stress, run by Brigham and Women's Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Generalized Anxiety, or Psychological Stress
- What is being tested?
- Caregiver Mental Health Mobile Application (CAMMA) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2023to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Caregiver who refuses to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Ministry of Public Health
Bangkok
Komatra Chuengsatiansup, MD, +66 626016116, loxlix@gmail.com
Siranee Sihapark, PhD, +66 810551215, daosiam@gmail.com
About this study
Official 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
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.
Read the 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.
- Being tested
- Caregiver Mental Health Mobile Application (CAMMA) Intervention, Usual Care Group
- Medical subject headings
- Depression, Generalized Anxiety Disorder, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Mental Health Mobile Application (CAMMA) InterventionBehavioural
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 GroupBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention condition | Experimental | Digital CAMMA intervention Receives: Behavioral: Caregiver Mental Health Mobile Application (CAMMA) Intervention |
| Control condition | Active comparator | Enhanced usual care Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Measured using the Patient Health Questionnaire-9 (PHQ-9)
Measured: 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)
Measured: 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)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Sep 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Symptoms, Generalized Anxiety, or Psychological StressStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Hongtu Chen, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722287
- Sponsor's protocol ID
- 2023P001212
- Other IDs
- 4R33MH131043-03
- Status last verified
- Jul 2026
- First submitted
- 5 Dec 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We need to decide on specific procedures and types of researchers for sharing the IPD.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06722287
- Acronym / sponsor ID
- 2023P001212
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention condition | Experimental | Behavioral: Caregiver Mental Health Mobile Application (CAMMA) InterventionDigital CAMMA intervention |
| Control condition | Active comparator | Behavioral: Usual Care GroupEnhanced usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Caregiver who refuses to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregiver Mental Health Mobile Application (CAMMA) Intervention12-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. | Behavioural | Intervention condition |
| Usual Care Group12-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 | Behavioural | Control condition |
Primary outcome
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided. We need to decide on specific procedures and types of researchers for sharing the IPD.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Mental Health Mobile Application (CAMMA) Intervention in people with Depressive Symptoms, Generalized Anxiety, or Psychological Stress, run by Brigham and Women's Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongtu Chen, PhD (617 459 5072, hchen@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.