Reducing the Psychosocial Impact of the Covid-19 Pandemic on Workers of Assisted Living Facilities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
研究概览
简要总结
The current study is a randomized controlled trial (RCT) that aims to evaluate the effectiveness of a stepped-care program (Doing What Matters [DWM] and Problem Management Plus [PM+]) in reducing anxiety and depression symptoms amongst long-term care workers (LTCWs), following changes in care due to the COVID-19 pandemic.
详细描述
Background: The COVID-19 pandemic has impacted the mental health of long-term care workers (LTCWs). This study combines two low-intensity psychological interventions developed by the World Health Organization (Doing What Matters [DWM] and Problem Management Plus [PM+]) into a stepped-care program for LTCWs.
Objective: To evaluate the implementation of a stepped-care program (DWM; PM+) amongst LTCWs following changes in care due to the COVID-19 pandemic in terms of mental distress, resilience and wellbeing.
Study design: A randomized controlled implementation trial with a single-blinded, parallel-group design.
Study population: Long-term care workers (including workers of assisted living facilities and home care) with self-reported elevated psychological distress.
Intervention-study: All participants (in both the treatment and the comparison group) will receive Psychological First Aid (PFA) and care as usual (CAU). In addition to PFA and CAU, the treatment group will receive the stepped-care intervention (DWM with or without PM+). The stepped-care intervention consists of DWM (step 1) and conditionally PM+ (step 2) if participants still meet criteria for psychological distress (Kessler Psychological Distress scale (K10) >15.9) 1 month after having received DWM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years or older;
- •Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).
- •Written/digital informed consent before entering the study.
- •Being a worker in a long-term care facility or a home care worker in the community of Catalonia.
排除标准
- •Having acute medical conditions (requiring hospitalization)
- •Imminent suicide risk, or expressed acute needs, or protection risks that require immediate follow-up
- •Having a severe mental disorder (e.g., psychotic disorders, substance-dependence)
- •Having severe cognitive impairment (e.g., severe intellectual disability or dementia)
- •Currently specialized psychological treatment (e.g., Eye movement desensitization and reprocessing, Cognitive behavioral therapy)
- •In case of current psychotropic medication use, being on an unstable dose for at least 2 months.
结局指标
主要结局
Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
时间窗: Change from baseline to 20 weeks
The PHQ-ADS is a 16-item self-reported instrument that combines the nine-item Patient Health Questionnaire depression scale and seven-item Generalized Anxiety Disorder scale-as a composite measure of depression and anxiety. Respondents are asked how much each symptom has bothered them over the past 2 weeks, with response options of "not at all", "several days", "more than half the days", and "nearly every day", scored as 0, 1, 2, and 3. The scale can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology.
次要结局
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)(Change: Baseline, 6 weeks, and 12 weeks)
- Patient Health Questionnaire (PHQ-9)(Baseline, 6 weeks, 12 weeks, and 20 weeks)
- Generalized Anxiety Disorder (GAD-7) scale(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)
- Posttraumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (PCL-5) - 8-item version(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)
- EuroQol 5-dimensional descriptive system - 5-level version (EQ-5D-5L)(Baseline, 6 weeks, 12 weeks, and 20 weeks)
- Client Service Receipt Inventory (CSRI) - adaptation(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)