Depression, AnxietyNCT06461637
Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers
A study testing Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) in people with Depression, Anxiety, run by Chinese University of Hong Kong.
Trial summary
The goal of this pilot randomized controlled trials is to assess the effectiveness of the stepped care approach in treating common mental disorders among foreign domestic helpers in Hong Kong and improve their access to evidence-based psychological treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Foreign domestic helpers aged 18 to 65 years;
- Able to read, write, and speak in English;
- Have a PHQ-9 score ≥10 and/or GAD-7 ≥8, indicating caseness or a score that can be classified as a clinical case;
- Have an internet-enabled device (e.g., laptop computer, smartphone, or tablet);
- willingness to provide informed consent and comply with the trial protocol.
Who cannot join
- Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview (MINI-7);
- Having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians);
- Current serious suicidal risk as assessed by PHQ-9 Item 9 score >2 (referral information to professional mental health services will be provided);
- Hospitalization or pregnancy;
- Current participation in any other clinical trial(s);
- Current psychological treatment for CMD either psychotherapy or unstable medication in the past 2 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers: A Pilot Randomized Controlled Trial
The goal of this pilot randomized controlled trials is to assess the effectiveness of the stepped care approach in treating common mental disorders among foreign domestic helpers in Hong Kong and improve their access to evidence-based psychological treatments.
Participants will be required to complete an online consent form. Then, around 240 eligible participants aged 18-65 years with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) and/or anxiety (Generalized Anxiety Disorder-7 [GAD-7] ≥ 8) will be randomly assigned to the intervention and control group in a ratio of 1:1. Participants assigned in the intervention group will recieved the stepped-care mental health intervention while those assigned to the control group will receive care-as-usual. Assessments of depression, anxiety, and insomnia symptoms, as well as work and social adjustment, quality of life, and treatment credibility and acceptability will be conducted at baseline, week 7 (after Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up). An assessment of barriers to accessing care will also be collected before treatment.
- Conditions
- Depression, Anxiety
- Being tested
- Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)
- Keywords
- depression, anxiety, stepped-care model, randomized controlled trial, foreign domestic helpers
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)Behavioural
The SCMH-FDH intervention consists of 4 steps. Step 1 involves a self-help intervention (through 12 mental health booklets) delivered in 6 sessions and an online peer support group. Those who did not respond to Step 1 will be referred to Step 2 (group-based resilience workshop). The intervention will be also be delivered in 6 weekly sessions lasting 1-1.5-hours. Those who did not respond to Step 2 will be referred to Step 3 (guided self-help cognitive behavioral therapy, CBT) with guidance from a trained therapist. Self-help materials will be provided. The sessions are spread out over six weeks, with each sessions lasting 30-45 minutes. Those who did not respond to Step 3 will be referred to Step 4 (high intensity interventions provided by mental health professionals). Stepping up is determined by the IAPT-minimum data set. If assessment scores after previous treatment exceeds the defined threshold (PHQ-9 ≥ 10 or GAD-7 ≥ 8), then participants need to step up to the next intervention.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) | Experimental | Participants in the SCMH-FDH group will receive a 4-step intervention, i.e., Step 1: Self-Help Intervention and Online Peer-Support, Step 2: Group-Based Intervention, Step 3: Guided Self-Help CBT, and Step 4: Referral to mental health professionals. Receives: Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) |
| Care-As-Usual (CAU) | No intervention | Participants in CAU group will not receive the stepped care intervention but will have access to care based on their needs and preferences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Patient Health Questionnaire-9 (PHQ-9)
A 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depressive symptoms. It is rated using a 4-point Likert scale from not at all (0), several days (1), more than half the days (2), and nearly every day (3).
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Generalized Anxiety Disorder-7 (GAD-7)
A 7-item questionnaire assessing the severity of anxiety over the past two weeks. It is rated using a 4-point Likert scale not at all (0), several days (1), more than half the days (2), and nearly every day (3).
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Work and Social Adjustment Scale (WSAS)
A 5-item instrument used for assessing work, social and leisure functioning as well as relationship interaction and home management. It is rated on a 9-point scale from 0 (not at all a problem) to 8 (very severely impaired), with combined score ranging from 0 - 40.
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Secondary outcomes (5)
Change in the Insomnia Severity Index (ISI)
A 7-item scale designed to evaluate perceived insomnia severity, distress and functional impairment associated with insomnia. It is rated using a 5-point Likert scale from none (0), mild (1), moderate (2), severe (3), and very severe (4) for questions 1 to 3, and very satisfied (0), satisfied (1), moderately satisfied (2), dissatisfied (3), and very dissatisfied (4) for questions 4 to 7.
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Credibility-Expectancy Questionnaire (CEQ)
A 6-item questionnaire assessing treatment credibility, acceptability/satisfaction, and expectations for success. Two subscales, treatment credibility and outcome expectation, make up the instrument. It is scored on a 9-point Likert scale ranging from not at all (1), somewhat (5) and very much (9).
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
Change in the Short-Form Six-Dimension (SF-6D)
A 6-item instrument measuring health-related quality of life, including physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Treatment Acceptability/Adherence Scale (TAAS)
A 10-item questionnaire that is rated by a seven-point Likert scale from 1 (disagree strongly) to 7 (agree strongly). It aims at evaluating treatment acceptability and anticipated treatment adherence of clients in the aspects of credibility, expectancy, and distress.
Measured: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
Assessment of the Barriers to Access to Care Evaluation Scale (BACE)
A 30-item scale used to identify key barriers experienced by people accessing mental health services. It is rated using a 4-point Likert scale from not at all (0), a little (1), quite a lot (2), and a lot (3).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
- Investigators
- Fiona Yan-Yee Ho, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461637
- Sponsor's protocol ID
- PSY034
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06461637
- Acronym / sponsor ID
- PSY034
- Conditions
- Depression, Anxiety
- Keywords
- depression, anxiety, stepped-care model, randomized controlled trial, foreign domestic helpers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Jun 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 goal of this pilot randomized controlled trials is to assess the effectiveness of the stepped care approach in treating common mental disorders among foreign domestic helpers in Hong Kong and improve their access to evidence-based psychological treatments.
Participants will be required to complete an online consent form. Then, around 240 eligible participants aged 18-65 years with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) and/or anxiety (Generalized Anxiety Disorder-7 [GAD-7] ≥ 8) will be randomly assigned to the intervention and control group in a ratio of 1:1. Participants assigned in the intervention group will recieved the stepped-care mental health intervention while those assigned to the control group will receive care-as-usual. Assessments of depression, anxiety, and insomnia symptoms, as well as work and social adjustment, quality of life, and treatment credibility and acceptability will be conducted at baseline, week 7 (after Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up). An assessment of barriers to accessing care will also be collected before treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) | Experimental | Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)Participants in the SCMH-FDH group will receive a 4-step intervention, i.e., Step 1: Self-Help Intervention and Online Peer-Support, Step 2: Group-Based Intervention, Step 3: Guided Self-Help CBT, and Step 4: Referral to mental health professionals. |
| Care-As-Usual (CAU) | No intervention | –Participants in CAU group will not receive the stepped care intervention but will have access to care based on their needs and preferences. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Foreign domestic helpers aged 18 to 65 years;
- Able to read, write, and speak in English;
- Have a PHQ-9 score ≥10 and/or GAD-7 ≥8, indicating caseness or a score that can be classified as a clinical case;
- Have an internet-enabled device (e.g., laptop computer, smartphone, or tablet);
- willingness to provide informed consent and comply with the trial protocol.
Key exclusion criteria (6 listed)
- Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview (MINI-7);
- Having a medical condition or neurocognitive disorder that may prevent lifestyle modifications based on the research team's clinical knowledge and experience (e.g., at high risk of fall or dietary change is not suitable as recommended by physicians or dietitians);
- Current serious suicidal risk as assessed by PHQ-9 Item 9 score >2 (referral information to professional mental health services will be provided);
- Hospitalization or pregnancy;
- Current participation in any other clinical trial(s);
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 |
|---|---|---|
| Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)The SCMH-FDH intervention consists of 4 steps. Step 1 involves a self-help intervention (through 12 mental health booklets) delivered in 6 sessions and an online peer support group. Those who did not respond to Step 1 will be referred to Step 2 (group-based resilience workshop). The intervention will be also be delivered in 6 weekly sessions lasting 1-1.5-hours. Those who did not respond to Step 2 will be referred to Step 3 (guided self-help cognitive behavioral therapy, CBT) with guidance from a trained therapist. Self-help materials will be provided. The sessions are spread out over six weeks, with each sessions lasting 30-45 minutes. Those who did not respond to Step 3 will be referred to Step 4 (high intensity interventions provided by mental health professionals). Stepping up is determined by the IAPT-minimum data set. If assessment scores after previous treatment exceeds the defined threshold (PHQ-9 ≥ 10 or GAD-7 ≥ 8), then participants need to step up to the next intervention. | Behavioural | Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) |
Primary outcome
Change in the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
A 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depressive symptoms. It is rated using a 4-point Likert scale from not at all (0), several days (1), more than half the days (2), and nearly every day (3).
Change in the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
A 7-item questionnaire assessing the severity of anxiety over the past two weeks. It is rated using a 4-point Likert scale not at all (0), several days (1), more than half the days (2), and nearly every day (3).
Change in the Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
A 5-item instrument used for assessing work, social and leisure functioning as well as relationship interaction and home management. It is rated on a 9-point scale from 0 (not at all a problem) to 8 (very severely impaired), with combined score ranging from 0 - 40.
5 secondary outcomes
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
Change in the Short-Form Six-Dimension (SF-6D)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Change in the Treatment Acceptability/Adherence Scale (TAAS)
Time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
Assessment of the Barriers to Access to Care Evaluation Scale (BACE)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Fiona Yan-Yee Ho study chair
Chinese University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) in people with Depression, Anxiety, run by Chinese University of Hong Kong.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Paolo R Yema (3943 6575, dryema@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Patient Health Questionnaire-9 (PHQ-9) (time frame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)). 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 17 Jun 2024.