Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers

Not Applicable

Not yet recruiting

• Conditions: Depression, Anxiety
• Interventions: Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)

• Registration Number: NCT06461637
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Study Start: 2024-07
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Foreign domestic helpers aged 18 to 65 years;
2. Able to read, write, and speak in English;
3. Have a PHQ-9 score ≥10 and/or GAD-7 ≥8, indicating caseness or a score that can be classified as a clinical case;
4. Have an internet-enabled device (e.g., laptop computer, smartphone, or tablet);
5. willingness to provide informed consent and comply with the trial protocol.

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Exclusion Criteria

1. Meeting DSM-5 diagnosis of a severe mental illness including psychotic or bipolar disorders as determined by the Mini International Neuropsychiatric Interview (MINI-7);
2. 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);
3. Current serious suicidal risk as assessed by PHQ-9 Item 9 score >2 (referral information to professional mental health services will be provided);
4. Hospitalization or pregnancy;
5. Current participation in any other clinical trial(s);
6. Current psychological treatment for CMD either psychotherapy or unstable medication in the past 2 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)	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.

Primary Outcome Measures

Name	Time	Method
Change in the Generalized Anxiety Disorder-7 (GAD-7)	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)	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.
Change in the Patient Health Questionnaire-9 (PHQ-9)	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).

Secondary Outcome Measures

Name	Time	Method
Change in the Credibility-Expectancy Questionnaire (CEQ)	Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)	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).
Change in the Short-Form Six-Dimension (SF-6D)	Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)	A 6-item instrument measuring health-related quality of life, including physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Assessment of the Barriers to Access to Care Evaluation Scale (BACE)	Baseline	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).
Change in the Insomnia Severity Index (ISI)	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 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.
Change in the Treatment Acceptability/Adherence Scale (TAAS)	Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)	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.