An interventional study of Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) in Depression, Anxiety, sponsored by Chinese University of Hong Kong. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 240 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)
Participants in CAU group will not receive the stepped care intervention but will have access to care based on their needs and preferences.
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.
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).
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 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).
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 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.
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 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.
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)
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).
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)
A 6-item instrument measuring health-related quality of life, including physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
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)
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.
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)
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).
Time frame: Baseline
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese University of Hong Kong