A Scalable Low-intensity Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers Involved in the First COVID-19 Outbreak in Spain: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
研究概览
简要总结
Rationale: The COVID-19 pandemic has impacted the mental health of healthcare workers (HCWs). 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 HCWs.
Objective: The main objective is to evaluate the implementation and (cost-)effectiveness of the culturally and contextually adapted DWM/PM+ stepped-care programs amongst health care workers during the COVID-19 pandemic in terms of mental distress, resilience, wellbeing, health inequalities, and costs to health systems.
Study design: Phase 2 (intervention study): pragmatic implementation trial with a single-blinded, randomized, parallel-group design. Phase 3: qualitative process evaluation consisting of individual interviews and focus group discussions (FGDs).
Study population: Study phase 2: Health care workers with self-reported elevated psychological distress. Study phase 3: study participants with different trajectories through the trial (completers, non-completers, drop-outs, etc.), family members/close persons of participants, professionals, and facilitators of the DWM and PM+ intervention.
Intervention- study phase 2: 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+) in addition to CAU. 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.
Main study parameters/endpoints: Phase 2: Screening for in- and exclusion criteria will be interviewer-administered, in-person or through (video) calls. Online assessments will take place at baseline, at 2 weeks after having received DWM, at 1 week and at 2 months after having received PM+. The main study parameter will be the decrease in symptoms of anxiety and depression from baseline to two-month follow-up, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). Phase 3: Through FGDs and interviews at the end of the study, the feasibility of scaling-up the implementation on the stepped-care DWM/PM+ intervention.
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)
盲法说明
Outcomes assessor will not know whether a single participant was allocated to the experimental or to the control arm. That will be done by assigning random values toe the variable "arm" in the dataset.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
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)(Change: 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)(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)
- Client Service Receipt Inventory (CSRI) - RESPOND adaptation(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)
- Stressor Reactivity(Change: Baseline, 6 weeks, 12 weeks, and 20 weeks)