Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers

Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression, Anxiety
• Intervention / Treatment: Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH)

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Paolo R Yema; Phone Number: 3943 6575; Email: dryema@link.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Stepped Care Mental Health for Foreign Domestic Helpers (SCMH-FDH); 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.
No Intervention: Care-As-Usual (CAU); Participants in CAU group will not receive the stepped care intervention but will have access to care based on their needs and preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Chair: Fiona Yan-Yee Ho, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; depression; anxiety; stepped-care model; foreign domestic helpers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: PSY034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No