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

NCT05033210 | Unknown

• 1 other identifier: ANRS0065s
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 2

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

Keywords

Mental Health; Psychological Distress; COVID-19; Unstable Housing; Psychosocial interventions; Human Migration

Outcome Measures

Primary Outcomes (1)

• PHQ-ADS

  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).

  Week 2, Week 8, Week 14, Week 22

Secondary Outcomes (9)

• 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

Other Outcomes (5)

• Socio-demographic information

  Week 2, Week 8, Week 14, Week 22

• BTQ: Brief Trauma Questionnaire

  Week 2, Week 14, Week 22

• Treatment fidelity

  Weeks 3 to 7, 9 to 13

Study Arms (2)

Control Group

OTHER

The control group will receive Psychological First Aid (PFA) and Care as Usual (CAU)

Behavioral: Psychological First Aid (PFA); Behavioral: Care as Usual (CAU)

Treatment Group

EXPERIMENTAL

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.

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

Interventions

Psychological First Aid (PFA) BEHAVIORAL

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).

Control Group; Treatment Group

Care as Usual (CAU) BEHAVIORAL

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

Control Group; Treatment Group

Doing What Matters in Times of Stress (DWM) BEHAVIORAL

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.

Treatment Group

Problem Management Plus (PM+) BEHAVIORAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (2)

Normandy Psychotrauma Center

Caen, Normandy, 14000, France

NOT YET RECRUITING

CAPSYS

Paris, Île-de-France Region, 75020, France

RECRUITING

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MeSH Terms

Conditions

Psychological Well-Being; COVID-19

Interventions

Psychological First Aid

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Emergency Services, Psychiatric; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Andrea Tortelli, Doctor

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

• Maria Melchior, Doctor

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Andrea Tortelli, Doctor

CONTACT

6.84.33.72.74; andrea.tortelli@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: After screening and baseline assessments, participants will be randomised to either the treatment group (n=105) or the comparison group (n=105), with an equal probability of assignment to each group (allocation ratio 1:1). The trial is a single-blind RCT (i.e. outcome assessors are blind to treatment allocation). Randomisation will be carried out through computerised software (Castor EDC) using limited block size (e.g. 6-12 participants per block) and will be performed by an independent person who is not involved in the assessment.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 2, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: October 1, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available from the end of the research and will be stored during 15 years.
• Access Criteria: Data will be shared with the different partners of the RESPOND Project through CASTOR EDC to conduct different analysis even after the end of the research project. Each individual having access to CASTOR will have its own password, and the rights of every user of this software in a particular country will be decided by the project manager of that country.

Locations

FR (2)