Brief Summary

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.

Conditions

• Psychological Distress
• Quality of Life
• Psychosocial Intervention

Intervention / Treatment

• Behavioral: Psychological First Aid (PFA)
• Behavioral: Care as Usual (CAU)
• Behavioral: Doing What Matters in Times of Stress (DWM)
• Behavioral: Problem Management Plus (PM+)

Primary Outcome Measures

• PHQ-ADS (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).

Countries

France

Locations and Investigators

• Normandy Psychotrauma Center, Caen, France (Not yet recruiting)
  • Eric Bui, MD
• CAPSYS, Paris, France (Recruiting)
  • Andrea Tortelli, MD

Study Officials

• Andrea Tortelli, Doctor (Principal Investigator) — Institut National de la Santé Et de la Recherche Médicale, France
• Maria Melchior, Doctor (Study Director) — Institut National de la Santé Et de la Recherche Médicale, France