Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers
NCT Number: NCT06461637
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression, Anxiety
Interventions: BEHAVIORAL: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2025-06

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.

Primary Outcome Measures: 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)., 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)., 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., Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
Secondary Outcome Measures: 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., 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)., 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., 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., 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)., Baseline