Stepped Care Treatment for Common Mental Disorders Among Foreign Domestic Helpers: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Change in the Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in the Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
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).
Change in the Work and Social Adjustment Scale (WSAS)
时间窗: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
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.
Change in the Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, week 7 (After Step 1), week 14 (after Step 2), week 21 (after Step 3), and week 33 (12-week follow-up)
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).
次要结局
- 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))
- Assessment of the Barriers to Access to Care Evaluation Scale (BACE)(Baseline)
- 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 Treatment Acceptability/Adherence Scale (TAAS)(Baseline, week 7 (After Step 1), week 14 (after Step 2), and week 21 (after Step 3))
研究者
Fiona YY Ho
Associate Professor
Chinese University of Hong Kong