Resilience, PsychologicalNCT07712744
Resilience-Building Intervention for Older Informal Caregivers
A study testing Multicomponent Resilience-building Program and AI Chatbot and Telephone Follow-up Group in people with Resilience, Psychological and Older Adults (60 - 85 Years Old), run by National University of Singapore.
Trial summary
The goal of this pilot study is to test whether a newly developed resilience-building program is feasible and acceptable for older adults who provide unpaid care to people with functional impairment in the community. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Older Adults (60 - 85 Years Old), Community Dwelling
- What is being tested?
- Multicomponent Resilience-building Program and AI Chatbot and Telephone Follow-up Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Mar 2027
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be aged 60 to 85 years;
- Reside in the community;
- Be attending a participating Lions Befrienders Active Ageing Centre;
- Be able to communicate in English or Mandarin;
- Have an Abbreviated Mental Test (AMT) score of 8 or above;
- Self-identify as an informal caregiver providing unpaid care to a family member, friend, or other individual;
- Provide care to a care recipient with impairment in at least one activity of daily living, as assessed using the Older Americans Resources and Services Activities of Daily Living (OARS-ADL) scale;
- Have at least weekly contact with the care recipient.
Who cannot join
- Have severe visual or hearing impairment that would prevent participation in study activities;
- Have a known diagnosis of dementia or other severe cognitive impairment;
- Have a known diagnosis of a severe psychiatric disorder that may impair study participation (e.g., psychotic disorders);
- Have an AMT score below 8;
- Provide care primarily to grandchildren or children under 18 years of age, rather than to an adult with functional impairment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Vivien Xi Wu contact
About this study
Official title: Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility Trial
The goal of this pilot study is to test whether a newly developed resilience-building program is feasible and acceptable for older adults who provide unpaid care to people with functional impairment in the community. The program was developed based on earlier research with older caregivers, existing scientific evidence, and feedback from key stakeholders.
The main questions this study aims to answer are:
Read more
- Can older caregivers be successfully recruited and retained in the study?
- Is the program feasible and acceptable to deliver in community settings?
- Does the program show potential to improve resilience among older caregivers?
Researchers will compare:
- an intervention group receiving an 8-week multicomponent resilience-building intervention delivered through alternating in-person and online sessions at participating Active Ageing Centres and through Telegram group video calls. The program includes psychoeducation, peer support group, and access to an artificial intelligence (AI) chatbot developed to support caregivers.
- an active control group receiving access to the AI chatbot and weekly telephone follow-up only.
- a control group continuing their usual caregiving routine.
Participants will:
- Be assigned to 1 of the 3 study groups based on the Active Ageing Centre they attend.
- Complete self-reported questionnaires before the intervention (T0, baseline), immediately after the intervention (T1, post-intervention), and 3 months later (T2, follow-up).
- Some participants may also be invited to participate in focus group discussions after the 8-week intervention period as part of a process evaluation to explore their experiences, perceived usefulness of the intervention components, barriers and facilitators to participation, and recommendations for refinement.
Findings from this pilot study will help refine the intervention and study procedures of a larger future trial.
- Conditions
- Resilience, Psychological, Older Adults (60 - 85 Years Old), Community Dwelling, Informal Caregiver
- Being tested
- Multicomponent Resilience-building Program, AI Chatbot and Telephone Follow-up Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Resilience-building ProgramBehavioural
Participants in the intervention group will receive the THRIVE program, an 8-week multicomponent resilience-building intervention developed based on prior participant need assessment, empirical evidence on resilience theory and caregiver resilience interventions, and stakeholder input. The intervention aims to strengthen psychological resilience among older informal caregivers. The format will be alternating in-person and online sessions conducted weekly over 8 weeks. In-person sessions will be held at participating Active Ageing Centres, while online sessions will be conducted through Telegram group video calls. Each 1.5-hour session will include: 1) psychoeducation; 2) peer support group sharing; and 3) an AI chatbot trained using local official resources. Sessions will be delivered by the same trained facilitator using a standardized intervention protocol. An independent observer will complete a fidelity checklist during each session to assess adherence to the protocol.
AI Chatbot and Telephone Follow-up GroupBehavioural
Participants will receive access to the same AI chatbot trained using information from local official health education and caregiving support resources. Participants will also receive weekly telephone follow-up calls from the research team over the 8-week study period. The telephone follow-ups aim to: 1) encourage use of the AI chatbot; 2) address any technical difficulties encountered during chatbot use; and 3) gather participants' feedback and experiences using a standardized telephone follow-up guide. All telephone calls will be audio-recorded and reviewed by the research team for fidelity monitoring to ensure consistency of delivery across participants.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Resilience-building Program | Experimental | 8-week multicomponent resilience-building intervention comprising alternating weekly in-person and online sessions. Key components include: 1) psychoeducation; 2) peer support group sharing; and 3) access to an AI chatbot for caregiving support. Receives: Behavioral: Multicomponent Resilience-building Program |
| AI Chatbot and Telephone Follow-up Group | Active comparator | Access to the AI chatbot trained using local official health education and caregiving support resources, with weekly telephone follow-up calls to guide chatbot use and address technical difficulties. Receives: Behavioral: AI Chatbot and Telephone Follow-up Group |
| Usual Practice | No intervention | Participants in the control arm will not receive the intervention or access to the AI chatbot during the study period until the last follow-up assessment. They will continue their usual caregiving routine and existing care practices as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible participants who provide informed consent and complete baseline assessment.
Measured: From date of randomization until the date of first session of the intervention, assessed up to 2 months.
Participant Retention Rate
Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.
Measured: Assessed from the first session of the intervention to Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Intervention Adherence
Participant adherence to intervention activities, including attendance at in-person and online sessions, completion of telephone follow-up calls, and engagement metrics with the AI chatbot.
Measured: Throughout the 8-week intervention period.
Intervention Acceptability
Participant acceptability of the intervention will be assessed using a post-intervention satisfaction survey and qualitative feedback collected through focus group discussions to explore participants' experiences, perceived usefulness of the intervention, barriers and facilitators to participation, and recommendations
Measured: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
AI Chatbot Usability
Usability of the AI chatbot will be assessed using the Simplified System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale. Responses are converted to produce a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Measured: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
Secondary outcomes (6)
Psychological Resilience
Assessed using the Connor-Davidson Resilience Scale (CD-RISC-25) to explore preliminary trends in intervention effects on resilience. The CD-RISC-25 consists of 25 items, with total scores ranging from 0 to 100. Higher scores indicate greater psychological resilience.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Intrinsic Capacity
Intrinsic capacity will be assessed using the World Health Organization (WHO) Integrated Care for Older People (ICOPE) screening tool to explore preliminary trends in intervention effects on intrinsic capacity. The tool assesses six domains of intrinsic capacity. Each domain is scored as 1 if no impairment is identified and 0 if impairment is present, yielding a total score ranging from 0 to 6, with higher scores indicating better intrinsic capacity.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Health Self-Efficacy
Health self-efficacy will be assessed using the Self-Rated Abilities for Health Practices Scale (SRAHP). The SRAHP consists of 28 items assessing self-perceived ability to perform health-promoting behaviours across four domains: exercise, nutrition, responsible health practices, and psychological well-being. Total scores range from 0 to 112, with higher scores indicating greater health self-efficacy for health-promoting practices.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Social Isolation
Social isolation will be assessed using the Social Isolation Scale (SIS). The SIS consists of 6 items assessing the size and quality of participants' social relationships and social connectedness. Total scores range from 6 to 30, with higher scores indicating lower levels of social isolation (greater social connectedness) and lower scores indicating greater social isolation.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Caregiver burden
Caregiver burden will be assessed using the 4-item Zarit Burden Interview (ZBI-4). The ZBI-4 consists of 4 items assessing the perceived impact of caregiving on the caregiver's time, stress, strain, and uncertainty. Total scores range from 0 to 16, with higher scores indicating greater caregiver burden.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Resource Awareness and Navigation
This outcome will be assessed using a study-specific 2-item questionnaire developed for this pilot study. The questionnaire evaluates participants' awareness of caregiving support services and confidence in accessing caregiving support when needed. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores range from 2 to 10, with higher scores indicating greater awareness and confidence in accessing caregiving support resources.
Measured: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a 3-arm parallel cluster randomized design. Participating Active Ageing Centres will be randomly assigned to one of three groups: the THRIVE intervention group, the active control group, or the usual care control group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Befrienders Service Association (Singapore), FlocCare Pte. Ltd, National University Health System, Singapore
- Responsible party
- Principal investigator, Vivien Xi WU, PhD, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712744
- Sponsor's protocol ID
- NUS-IRB-2023-889
- Other IDs
- A-8001599-00-00
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing of de-identified individual participant data has not yet been finalized. Data sharing will be considered following study completion, taking into account participant consent, ethical and regulatory requirements, institutional policies, and the potential risk of participant re-identification due to the relatively small sample size and specific study population.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Resilience-Building Intervention for Older Informal Caregivers: Protocol for a Cluster Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT07712744
- Acronym / sponsor ID
- NUS-IRB-2023-889
- Conditions
- Resilience, Psychological, Older Adults (60 - 85 Years Old), Community Dwelling, Informal Caregiver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Lions Befrienders Service Association (Singapore), FlocCare Pte. Ltd, National University Health System, Singapore
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jul 2026 (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 goal of this pilot study is to test whether a newly developed resilience-building program is feasible and acceptable for older adults who provide unpaid care to people with functional impairment in the community. The program was developed based on earlier research with older caregivers, existing scientific evidence, and feedback from key stakeholders.
The main questions this study aims to answer are:
- Can older caregivers be successfully recruited and retained in the study?
- Is the program feasible and acceptable to deliver in community settings?
- Does the program show potential to improve resilience among older caregivers?
Researchers will compare:
- an intervention group receiving an 8-week multicomponent resilience-building intervention delivered through alternating in-person and online sessions at participating Active Ageing Centres and through Telegram group video calls. The program includes psychoeducation, peer support group, and access to an artificial intelligence (AI) chatbot developed to support caregivers.
- an active control group receiving access to the AI chatbot and weekly telephone follow-up only.
- a control group continuing their usual caregiving routine.
Participants will:
- Be assigned to 1 of the 3 study groups based on the Active Ageing Centre they attend.
- Complete self-reported questionnaires before the intervention (T0, baseline), immediately after the intervention (T1, post-intervention), and 3 months later (T2, follow-up).
- Some participants may also be invited to participate in focus group discussions after the 8-week intervention period as part of a process evaluation to explore their experiences, perceived usefulness of the intervention components, barriers and facilitators to participation, and recommendations for refinement.
Findings from this pilot study will help refine the intervention and study procedures of a larger future trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study uses a 3-arm parallel cluster randomized design. Participating Active Ageing Centres will be randomly assigned to one of three groups: the THRIVE intervention group, the active control group, or the usual care control group.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Resilience-building Program | Experimental | Behavioral: Multicomponent Resilience-building Program8-week multicomponent resilience-building intervention comprising alternating weekly in-person and online sessions. Key components include: 1) psychoeducation; 2) peer support group sharing; and 3) access to an AI chatbot for caregiving support. |
| AI Chatbot and Telephone Follow-up Group | Active comparator | Behavioral: AI Chatbot and Telephone Follow-up GroupAccess to the AI chatbot trained using local official health education and caregiving support resources, with weekly telephone follow-up calls to guide chatbot use and address technical difficulties. |
| Usual Practice | No intervention | –Participants in the control arm will not receive the intervention or access to the AI chatbot during the study period until the last follow-up assessment. They will continue their usual caregiving routine and existing care practices as usual. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be aged 60 to 85 years;
- Reside in the community;
- Be attending a participating Lions Befrienders Active Ageing Centre;
- Be able to communicate in English or Mandarin;
- Have an Abbreviated Mental Test (AMT) score of 8 or above;
Key exclusion criteria (5 listed)
- Have severe visual or hearing impairment that would prevent participation in study activities;
- Have a known diagnosis of dementia or other severe cognitive impairment;
- Have a known diagnosis of a severe psychiatric disorder that may impair study participation (e.g., psychotic disorders);
- Have an AMT score below 8;
- Provide care primarily to grandchildren or children under 18 years of age, rather than to an adult with functional impairment.
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 |
|---|---|---|
| Multicomponent Resilience-building ProgramParticipants in the intervention group will receive the THRIVE program, an 8-week multicomponent resilience-building intervention developed based on prior participant need assessment, empirical evidence on resilience theory and caregiver resilience interventions, and stakeholder input. The intervention aims to strengthen psychological resilience among older informal caregivers. The format will be alternating in-person and online sessions conducted weekly over 8 weeks. In-person sessions will be held at participating Active Ageing Centres, while online sessions will be conducted through Telegram group video calls. Each 1.5-hour session will include: 1) psychoeducation; 2) peer support group sharing; and 3) an AI chatbot trained using local official resources. Sessions will be delivered by the same trained facilitator using a standardized intervention protocol. An independent observer will complete a fidelity checklist during each session to assess adherence to the protocol. | Behavioural | Multicomponent Resilience-building Program |
| AI Chatbot and Telephone Follow-up GroupParticipants will receive access to the same AI chatbot trained using information from local official health education and caregiving support resources. Participants will also receive weekly telephone follow-up calls from the research team over the 8-week study period. The telephone follow-ups aim to: 1) encourage use of the AI chatbot; 2) address any technical difficulties encountered during chatbot use; and 3) gather participants' feedback and experiences using a standardized telephone follow-up guide. All telephone calls will be audio-recorded and reviewed by the research team for fidelity monitoring to ensure consistency of delivery across participants. | Behavioural | AI Chatbot and Telephone Follow-up Group |
Primary outcome
Recruitment Rate
Time frame: From date of randomization until the date of first session of the intervention, assessed up to 2 months.
Proportion of eligible participants who provide informed consent and complete baseline assessment.
Participant Retention Rate
Time frame: Assessed from the first session of the intervention to Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Proportion of enrolled participants who complete the post-intervention (T1) and 3-month follow-up (T2) assessments.
Intervention Adherence
Time frame: Throughout the 8-week intervention period.
Participant adherence to intervention activities, including attendance at in-person and online sessions, completion of telephone follow-up calls, and engagement metrics with the AI chatbot.
Intervention Acceptability
Time frame: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
Participant acceptability of the intervention will be assessed using a post-intervention satisfaction survey and qualitative feedback collected through focus group discussions to explore participants' experiences, perceived usefulness of the intervention, barriers and facilitators to participation, and recommendations
AI Chatbot Usability
Time frame: Assessed at Post-intervention (T1): within 2 weeks after completion of the 8-week intervention.
Usability of the AI chatbot will be assessed using the Simplified System Usability Scale (SUS). The SUS consists of 10 items rated on a 5-point Likert scale. Responses are converted to produce a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
6 secondary outcomes
Psychological Resilience
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Intrinsic Capacity
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Health Self-Efficacy
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Social Isolation
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Caregiver burden
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
Resource Awareness and Navigation
Time frame: Assessed across 3 time-points: Baseline (T0): within 2 weeks before the first intervention session. Post-intervention (T1): within 2 weeks after completion of the 8-week intervention. Follow-up (T2): within 2 weeks after the 3-month follow-up time point.
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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided. The decision regarding sharing of de-identified individual participant data has not yet been finalized. Data sharing will be considered following study completion, taking into account participant consent, ethical and regulatory requirements, institutional policies, and the potential risk of participant re-identification due to the relatively small sample size and specific study population.
Related trials for Resilience, Psychological
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
Recruiting
A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
Burnout, Healthcare Workers, Breathing Exercises
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
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.
Vivien Xi Wu contact
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Resilience-building Program and AI Chatbot and Telephone Follow-up Group in people with Resilience, Psychological and Older Adults (60 - 85 Years Old), run by National University of Singapore.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ruochen Feng (+6566012756, rfeng@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From date of randomization until the date of first session of the intervention, assessed up to 2 months.). The study lists 5 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 17 Jul 2026.