Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers

NCT06461637 | Not Yet Recruiting

• 1 other identifier: PSY034
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression, Anxiety

Keywords

depression; anxiety; stepped-care model; randomized controlled trial; foreign domestic helpers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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)

• Change in the Credibility-Expectancy Questionnaire (CEQ)

  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)

  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)

  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)

  Baseline

Study Arms (2)

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.

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.

Interventions

Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH) BEHAVIORAL

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.

Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Fiona Yan-Yee Ho

  Chinese University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Dan Paolo R Yema

CONTACT

3943 6575; dryema@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share