Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- PHQ-ADS
研究概览
简要总结
The Covid-19 pandemic is having a great impact on the long-term mental health and well-being. Reports on the levels of psychological distress are concerning. This can be due to the pandemic, as well as social distancing, employment and economic consequences.
Healthcare workers, the elderly, youths, and persons experiencing socio-economic adversity are at risk of developing psychological distress. In this context, healthcare systems risk being overcharged, facing a growing demand.
Cognitive Behaviour Therapies managing psychological distress have been formally recommended. WHO has implemented different escalated psychosocial interventions, such as Problem Management Plus, PM+; Doing What Matters in Times of Stress, DWM; and Psychological First Aid, PFA. Their aim is to help individuals manage their stress in order to decrease the occurrence of psychological problems. They do not replace care for severe mental health disorders, but can prevent the deterioration of individuals' mental health.
PM+ has previously been found to be effective in situations of endemic conflict or violence in Pakistan and Kenya. The implementation of this program in Europe is being evaluated in the EU H2020 project STRENGHTS, focused in migrants from Syria. In the present trail, the investigators aim to further test its effectiveness in the context of psychological distress resulting from the COVID-19 pandemic.
Prior to the present trial, the investigators conducted a qualitative research study among potential beneficiaries and healthcare workers to evaluate the feasibility of DWM and PM+, which showed interest in stepped-care interventions in mental health, particularly if they are technology-based (mobile phones).
Our study is embedded in the larger, EU H2020 CORONAVIRUS-funded RESPOND project (Grant Agreement No 101016127). This project granted funding for a multicentric, single-blinded, randomised, controlled trial to evaluate the effectiveness of the stepped-care DWM and PM+ program vs. Care as Usual (CAU). In France, the investigators will focus on persons experiencing socioeconomic adversity, as defined by unstable housing conditions. A recent study showed that most of them are migrants. All subjects (210) will receive PFA and CAU. In addition to PFA and CAU, the treatment group (105 subjects) will receive the intervention DWM (with or without PM+). The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-months follow-up.
详细描述
STUDY POPULATION Our population is composed of adults (18 years or older), with unstable housing status , speaking one of the languages of the research (Arabic, Dari, French or Pashto).
CALCULATION OF THE SAMPLE SIZE Based on prior studies (Bryant et al., 2017; Rahman et al., 2016b), the investigators aim to detect a small to medium Cohen's d effect size of 0.3 in the PM+ group at 2 months post-treatment based on the primary composite outcome PHQ-ADS (Kroenke et al., 2016; 2019). The PHQ-ADS is the combined sum score of depression and anxiety symptoms of the PHQ-9 and GAD-7, respectively and has shown good internal consistency (α = .88 to .92) (Kroenke et al., 2016; 2019). A power calculation for a repeated measurement design (with STATA) suggests a minimum sample size of N=73 per group (power=0.80, alpha=0.05, two-sided, rho=0.9). Considering 30% attrition, the investigators aim to include a total number of 210 participants (105 in the stepped-care DWM/PM+ treatment group (with PFA and CAU) and 105 in the PFA and CAU comparison group).
STATISTICAL METHODS The statistical analysis will estimate the effectiveness of the stepped-care programs DWM/PM+ intervention compared to PSP and CAU alone.
The primary outcome (PHQ-ADS scale) will be summarized using the number of subjects (n), minimum and maximum; and means, standard deviations (SD) for normally distributed data, or medians and interquartile ranges for non-normally distributed data. To measure comparisons at baseline between the two treatment groups t-tests (continuous variables) or chi-squared tests (categorical variables) will be conducted for normally distributed data; Mann-Whitney tests will be conducted for continuous non-normally distributed data. Health economic analysis will be conducted to determine the difference in costs and outcomes in the intervention arm as compared to the care as usual group. Primary analysis will be the total costs over the 2-month follow-up treatment period. Between-group comparison of mean costs will be completed using standard t-test with ordinary least squares regression used for adjusted analysis, with the validity of results confirmed using bootstrapping.
ETHICAL CONSIDERATIONS This study will fully comply with relevant European and national regulations concerning data protection, privacy regulations, and the procedures for obtaining informed consent.
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
The statistical analysis will be masked, this means that the statistician will not know the treatment groups until the end of the analysis. In addition, this person will not be involved in the choice of the participants, the administration of the intervention, in study assessments or in data entry.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will have to be 18 years or older, without stable housing, meet the criteria for psychological distress (K10 > 15.9), speak one of the study languages (Arabic, French, Pashto, Dari) and agree to participate in the study.
排除标准
- •Individuals with an acute medical or psychiatric condition requiring urgent medical services, at risk for suicide, with moderate/severe cognitive impairment (e.g., severe intellectual disability or dementia), under juridical protection (guardianship, tutorship, legal safeguard), with a psychotropic treatment whose dose has changed during the last 2 months, or refusing to participate in the study will be excluded.
研究组 & 干预措施
Control Group
The control group will receive Psychological First Aid (PFA) and Care as Usual (CAU)
干预措施: Psychological First Aid (PFA) (Behavioral)
Control Group
The control group will receive Psychological First Aid (PFA) and Care as Usual (CAU)
干预措施: Care as Usual (CAU) (Behavioral)
Treatment Group
The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2), in addition to Psychological First Aid (PFA) and care as usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress (K10 > 15.9) at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM.
干预措施: Psychological First Aid (PFA) (Behavioral)
Treatment Group
The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2), in addition to Psychological First Aid (PFA) and care as usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress (K10 > 15.9) at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM.
干预措施: Care as Usual (CAU) (Behavioral)
Treatment Group
The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2), in addition to Psychological First Aid (PFA) and care as usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress (K10 > 15.9) at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM.
干预措施: Doing What Matters in Times of Stress (DWM) (Behavioral)
Treatment Group
The treatment group will receive the stepped-care program consisting of Doing What Matters (DWM) (step 1) and Problem Management Plus (PM+) (step 2), in addition to Psychological First Aid (PFA) and care as usual (CAU). Step 2 will only be provided if the participant still has elevated levels of psychological distress (K10 > 15.9) at 2 weeks after DWM, i.e. during the second quantitative assessment at 2 weeks after DWM.
干预措施: Problem Management Plus (PM+) (Behavioral)
结局指标
主要结局
PHQ-ADS
时间窗: Week 2, Week 8, Week 14, Week 22
The PHQ-ADS is the sum of the PHQ-9 and GAD-7 scores (details of both instruments summarised below) and thus can range from 0 to 48, with higher scores indicating higher levels of depression and anxiety symptomatology. Two validation studies of the PHQ-ADS in trial data-sets of patients with chronic (musculoskeletal) pain and oncological diseases have been published (Kroenke et al., 2016; Kroenke et al., 2019). Evidence shows high internal reliability (Cronbach's alpha of 0.8 to 0.9), strong convergent and construct validity, sufficient uni-dimensionality and evidence for sensitivity to change (i.e. differentiating between individuals classified as worse, stable, or improved by a reference measure at three months post-intervention).
次要结局
- Level of depression (PHQ-9)(Week 2, Week 8, Week 14, Week 22)
- Level of anxiety (GAD-7)(Week 2, Week 8, Week 14, Week 22)
- Severity of posttraumatic stress disorder (PCL-5)(Week 2, Week 8, Week 14, Week 22)
- Self-identified problems (PSYCHLOPS)(Week 2, Week 8, Week 14, Week 22)
- Psychotic symptoms (MINI)(Week 2, Week 8, Week 14, Week 22)
- Resilience based on exposure to stressful events, general and COVID-19 related (MIMIS)(Week 2, Week 8, Week 14, Week 22)
- Quality of life (EQ-5D-5L)(Week 2, Week 8, Week 14, Week 22)
- Cost of care: impact on use of health system, other services, time out of employment and other usual activities and need for informal care (CSRI)(Week 2, Week 8, Week 14, Week 22)
- Resilience factors: a positive approach (PASSc)(Week 2, Week 14, Week 22)