Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic

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

Interventions

BEHAVIORAL

Psychological First Aid (PFA)

PFA is a WHO developed support strategy that involves humane, supportive and practical help for individuals living in a serious humanitarian crisis. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promote in the aftermath of crises, i.e. a sense of safety, calm, self- and community efficacy, connectedness, and hope (Hobfoll et al., 2007). It consists of a conversation (approximately 30-45 minutes) that a helper has with a participant which can be provided remotely (e.g. videoconferencing or telephone). It has various themes; the helper provides non-intruding practical care and support, listen to needs and concerns, helps people to address basic needs (e.g. information), listens to people without pressuring them to talk, comforts people and helps them to feel calm, helps people to connect to information, services, and social support, and protects people from further harm (WHO, 2011).

BEHAVIORAL

Care as Usual (CAU)

In addition to PFA, both arms will be allowed to receive any usual care (CAU). CAU ranges from community care to specialised psychological treatments.

BEHAVIORAL

Doing What Matters in Times of Stress (DWM)

DWM is based on the acceptance and commitment therapy (ACT), a form of cognitive-behavioural therapy, with distinct features (Hayes, Levin, Plumb-Vilardaga, Villatte \& Pistorello, 2013). ACT is based on the concept that ongoing attempts to suppress unwanted thoughts and feelings can make these problems worse, so instead it emphasises on learning new ways to accommodate these thoughts and feelings without letting them dominate. ACT has been shown to be useful for a range of mental health issues (Tjak et al., 2015) and has been used successfully in a guided self-help format (Hayes et al., 2013). DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, will be adapted for use on a smartphone or other device with internet access.

BEHAVIORAL

Problem Management Plus (PM+)

PM+ is a brief, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011). The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. In these 90-minute sessions participants may talk to trained non-professional helpers (who are supervised by registered (clinical) psychologists). PM+ has four core features: it is brief (five sessions); delivered by non-specialist helpers; transdiagnostic thereby addressing depression, anxiety, PTSD, stress and problems as defined by people themselves; and originally designed for people in low-income country communities but easily adaptable to different (vulnerable) populations, cultures and languages.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Andrea Tortelli, Doctor · Institut National de la Santé Et de la Recherche Médicale, France

• Maria Melchior, Doctor · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2023-03-31

Completion

2023-10-31

Countries

• France

Study Locations