Clinical trial NCT05033210: Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic
Official title: Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Quality of Life
Psychosocial Intervention
Keywords: Mental Health
Psychological Distress
COVID-19
Unstable Housing
Psychosocial interventions
Human Migration
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2021-09-02
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

* Informed consent Before being enrolled in the study, participants will be informed by the project manager and/or the main investigator about the aims and scope of the study in a form understandable to them. The individual will have one week to decide if it participates. If so, he/she will sign the consent form with the main investigator.
* Withdrawal of individual subjects Participants can leave the study at any time for any reason if they wish to do so without any consequences for them. The investigator can decide to withdraw a participant from the study for urgent medical reasons.

If a subject decides to withdraw from the study, the investigator will ask for the reason. Withdrawal from the study will have no effect on the regular treatment. Subjects who leave the study for medical reasons will be followed until the interfering condition has resolved or reached a stable state.

* Monitoring Monitoring includes review of helpers' records of PM+, supervision records including intervention fidelity monitoring and supervision of supervisors by the master trainers. The supervision of helpers will be scheduled weekly. The supervision will be given by the study psychologist. The supervising psychologist will also receive supervision from the master trainers and these supervisions will be scheduled monthly. Audio recordings on the form helpers make the interventions and pass the questionnaires will be taken. These records will assess as well the adherence to the interventions. Monitoring of the assessments will be the responsibility of the supervisor. In case of any concerns about the capacity of the assessors to carry out their roles, the project manager will conduct full assessments to ensure quality. This oversight will help ensure that any potential concerns about the capacity of assessors to carry out their roles is picked up and responded to.
* Benefits and risks of the research Participants randomized into the DWM/PM+ treatment group may benefit from their participation in terms of expected reductions in psychological distress. The risks associated with participation are estimated to be minimal, since DWM and PM+ reduced psychological distress in previous studies (Purgato et al., 2019; Tol et al., 2020; Bryant et al., 2017; Rahman et al., 2016b). Participants in both the treatment and comparison group will not be withheld care as usual.

It is possible that participants experience stress during the PM+ sessions. The intervention will be supervised and strictly monitored by experienced psychologists. If a participant deteriorates during the intervention period, (s)he can be referred to an external specialist (licensed psychologist or psychiatrist). Whenever referral has taken place, it will be actively followed-up by the researchers. In case of an undesirable emotional reaction either during the intervention or during follow-up assessments, the researchers and clinicians will be available to provide support if necessary.

If a participant has elevated symptoms of psychological distress in follow-up assessments, (s)he will be advised to contact his/her general practitioner (part of the CAU), who may refer the participant for continued or high-intensity treatment.

- Adverse events (AE) Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the trial procedure or to the stepped care DWM and PM+ intervention. All AEs reported spontaneously by the subject or observed by the investigator or his staff will be recorded. All AEs will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated, and/or referral to the general physician or a medical specialist.

• Compensation for injury

Participation in the study only carries negligible risks for the research subjects; therefore. An insurance has been taken by the study promotor to guarantee its civil responsibility, according to the French Public Health Code.

* Incentives Participants will also receive 60 euros (in vouchers) in total (20 euros on visit 1, 20 euros on visit 3, and 20 euros on visit 4).
* Data management All data will be handled confidentially and will be coded by a code known only to the research team. Processing of personal data will comply with the General Data Regulation (GDPR). Additionally, this study adheres to the Research Data Management Policy of the ANRS.

Data including personal information will be stored in a locked file at INSERM to ensure the confidentiality of the study participants. Only authorized research personnel will have access to these data. According to the data management rules of RESPOND, all partners acknowledge and agree that no personal data, as defined in Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (GDPR), will be exchanged between the Parties. Moreover, all partners in RESPOND acknowledge and agree that each partner is considered an independent controller, as defined in GDPR, for its processing of personal data and will act in accordance with applicable data protection laws (including but not limited to GDPR).

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: PHQ-ADS
timeFrame: Week 2, Week 8, Week 14, Week 22
Secondary outcomes:
measure: Level of depression (PHQ-9)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Level of anxiety (GAD-7)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Severity of posttraumatic stress disorder (PCL-5)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Self-identified problems (PSYCHLOPS)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Psychotic symptoms (MINI)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Resilience based on exposure to stressful events, general and COVID-19 related (MIMIS)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Quality of life (EQ-5D-5L)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: 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)
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: Resilience factors: a positive approach (PASSc)
timeFrame: Week 2, Week 14, Week 22
Other outcomes:
measure: Socio-demographic information
timeFrame: Week 2, Week 8, Week 14, Week 22
measure: BTQ: Brief Trauma Questionnaire
timeFrame: Week 2, Week 14, Week 22
measure: Treatment fidelity
timeFrame: Weeks 3 to 7, 9 to 13
measure: Satisfaction and acceptability DWM/PM+
timeFrame: Week 8, Week 14
measure: Events related to the COVID-19 pandemic
timeFrame: Week 2, Week 8, Week 14, Week 22
Locations:
city: Caen
country: France
facility: Normandy Psychotrauma Center
state: Normandie
city: Paris
country: France
facility: CAPSYS
state: Île De France
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Andrea Tortelli, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Maria Melchior, Doctor
role: STUDY_DIRECTOR
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