Clinical trial NCT06461637: Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers
Official title: Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Keywords: depression
anxiety
stepped-care model
randomized controlled trial
foreign domestic helpers
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change in the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
measure: Change in the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
measure: Change in the Work and Social Adjustment Scale (WSAS)
timeFrame: 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:
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
measure: Change in the Short-Form Six-Dimension (SF-6D)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
measure: Change in the Treatment Acceptability/Adherence Scale (TAAS)
timeFrame: Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3)
measure: Assessment of the Barriers to Access to Care Evaluation Scale (BACE)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Fiona Yan-Yee Ho
role: STUDY_CHAIR
References: