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

Quality of Life Clinical Trial

— RESPOND-FR  

Official title:

Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033210
• Other study ID #: ANRS0065s
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: July 2022
• Source: ANRS, Emerging Infectious Diseases
• Contact: Andrea Tortelli, Doctor
• Phone: 6.84.33.72.74
• Email: andrea.tortelli[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: October 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Psychological Distress
• Psychosocial Intervention
• Quality of Life

Intervention

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).
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Normandy Psychotrauma Center	Caen	Normandie
France	CAPSYS	Paris	Île De France

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio-demographic information	Socio-demographic information will be collected with predefined items based on the REDEFINE and STRENGTHS studies (i.e. age, gender, nationality, years of education, relationship status, and main work-status and additional questions regarding country of birth, household population (incl. children < 18 and elderly people), household income on average, occupational area working, mental health condition and overall current health status and housing (square meters of the house, outdoor space available).	Week 2, Week 8, Week 14, Week 22
Other	BTQ: Brief Trauma Questionnaire	Brief self-report questionnaire derived from the Brief Trauma Interview (Schnurr et al., 1995). BTQ is designed to assess traumatic exposure. It provides a comprehensive assessment of DSM V Criterion A (stressors), of which exposure to trauma is an example.	Week 2, Week 14, Week 22
Other	Treatment fidelity	Process monitoring of the full stepped-care intervention includes review of helpers' records of DWM phone calls and PM+ sessions with clients; helpers' supervision records including intervention fidelity monitoring, and supervision of supervisors by intervention trainers. To monitor treatment fidelity of DWM, participants' usage of the DWM app will be tracked. To monitor treatment fidelity of PM+, treatment sessions will be audio-recorded. If participants are randomized into the treatment group, they will be asked for a separate consent to record the sessions. Giving consent to the audio recording is no requirement to receive the PM+ program.	Weeks 3 to 7, 9 to 13
Other	Satisfaction and acceptability DWM/PM+	Satisfaction and acceptability of the stepped-care DWM/PM+ intervention is measured through qualitative process evaluation. Additionally, at the first assessment after DWM (T2) and after PM+ (T3), participants will also fill out a questionnaire to measure their satisfaction with the intervention. The CSQ-I for the web-based intervention DWM (Boss et al., 2016) and the CSQ-8 for PM+ Client Satisfaction Questionnaire (CSQ-8; Attkisson & Zwick, 1982)	Week 8, Week 14
Other	Events related to the COVID-19 pandemic	We ask participants about events they have experienced in connection with the COVID-19 pandemic	Week 2, Week 8, Week 14, Week 22
Primary	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	Level of depression (PHQ-9)	Depressive symptoms during the past two weeks will be measured using the Patient Health Questionnaire depressive module. It asks how often someone was bothered by each of the nine DSM-5 criteria and scores answers on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) (Kroenke, Spitzer, & Williams, 2001). In addition to the nine items, the PHQ-9 asks: "If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?", which is to be answered with "Not difficult at all", "Somewhat difficult", "Very difficult", or "Extremely difficult". For the current study, changes in caseness in depression will be examined. A cut-off score of 10 will be used, which has been found to be a valid cut-off point for diagnosis (Manea, Gilbody & McMillan, 2021).	Week 2, Week 8, Week 14, Week 22
Secondary	Level of anxiety (GAD-7)	The Generalized Anxiety Disorder (GAD-7) questionnaire is a seven-item, self-report anxiety questionnaire which assesses the degree to which the patient has been bothered by feeling nervous, anxious or on edge over the last two weeks. Items also include other generalised anxiety symptoms such as being unable to stop worrying about multiple things, having trouble relaxing or sitting still, feeling irritable and being afraid of something bad happening at all times (Spitzer et al., 2006). Items are scored from 0 to 3, respectively for experiencing symptoms 'not at all', for 'several days', for 'more than half the days' and for 'nearly every day'. The total score ranges from 0 to 21. Cut-off points for mild, moderate and severe anxiety are scores of 5, 10 and 15, respectively (Spitzer et al., 2006). A score of 10 has been identified as the optimal cut-off score to balance specificity and sensitivity (Spitzer et al., 2006).	Week 2, Week 8, Week 14, Week 22
Secondary	Severity of posttraumatic stress disorder (PCL-5)	Posttraumatic stress disorder (PTSD) symptoms during the past week according to the DSM-5 PTSD diagnosis will be measured using the PTSD Checklist for DSM-5 (PCL-5) (Weathers et al., 2013). A shortened 8-item version of the original PCL-5 (a 20-item checklist which corresponds with the 20 DSM-5 PTSD symptoms) will be used. Items are rated on a 0-4 scale. Added up, the maximum severity score is 32. Higher scores indicate higher symptomatology. In a comparison of two abbreviated versions, i.e., the 4-item and 8-item versions of the PCL-5, the PCL-5 8 item version showed a strong correlation with the total scale, greater internal consistency, and allowed for sufficient variability in patient response. There were no significant differences in the sensitivity and specificity between the total 20-item PCL-5 scale and the 8-item scale (Price et al., 2016).	Week 2, Week 8, Week 14, Week 22
Secondary	Self-identified problems (PSYCHLOPS)	The Psychological Outcomes Profiles (PSYCHLOPS) scale is a patient-generated outcome measure as an indicator of change after therapy (Ashworth et al., 2004). PSYCHLOPS consists of four questions. It contains three domains: problems (2 questions), function (1 question), and wellbeing (1 question). Participants are asked to give free text responses to the problem and function domains. Responses are scored on an ordinal six-point scale producing a maximum score of 18 (six points per domain). PSYCHLOPS has been validated in primary care populations across several countries (Czachowski, Seed, Schofield, & Ashworth, 2011; Héðinsson, Kristjánsdóttir, Ólason, & Sigurðsson, 2013).	Week 2, Week 8, Week 14, Week 22
Secondary	Psychotic symptoms (MINI)	M.I.N.I is a structured diagnostic interview, validated in French (Sheehan et al., 1998), which explores in a standardised manner the main psychiatric troubles which appear in the first axis of the DSM-IV (American Psychiatric Association, 1994). We will use questions 1 to 7 from Item L (psychotic troubles), to determine the presence of psychotic symptoms during the last 6 months.	Week 2, Week 8, Week 14, Week 22
Secondary	Resilience based on exposure to stressful events, general and COVID-19 related (MIMIS)	The Mainz Inventory of Microstressors (MIMIS) was recently developed to measure objective microstressors of modern life in the past 7 days (Chmitorz et al., 2020). In the Dynacore-C study (Veer et al., 2021) this was changed into a period of 2 weeks and a shorter general and COVID-19 specific stressor list. The MIMIS uses a definition of resilience as a trade-off between the outcome of mental health and exposure to adversity. Outcome-based resilience will be assessed by relating self-reported changes in mental health problems (i.e. anxiety and depression) over the past 2 weeks (assessed with the PHQ-ADS) to the self-reported exposure to 11 categories of general stressors (life events and daily stressors such as physical health problems, family conflicts or separation form a loved one) and 29 COVID-19 crisis related stressors (such as COVID-19 symptoms, belonging to a risk group for serious COVID-19 symptoms, loss of social contact, or problems arranging childcare (Veer et al., 2021).	Week 2, Week 8, Week 14, Week 22
Secondary	Quality of life (EQ-5D-5L)	The EQ-5D-5L measures quality of life and consists of two parts, the EQ-5D and the EQ VAS. Part 1, the EQ-5D, rates the level of impairment across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ-5D-5L is an adapted version of the EQ-5D(-3L), which only had three response options for each dimensions and was therefore thought to not sufficiently capture milder health issues and small changes between different states of health (Herdman et al., 2011).	Week 2, Week 8, Week 14, Week 22
Secondary	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)	The Client Service Receipt Inventory (CSRI) was developed for the collection of data on service utilization (e.g. use of health system, other services, time out of employment and other usual activities, need for informal care) and related characteristics of people with mental disorders, as the basis for calculating the costs of care for mental health cost-effectiveness research.	Week 2, Week 8, Week 14, Week 22
Secondary	Resilience factors: a positive approach (PASSc)	PASSc is based on a positive approach to resilience theory (PASTOR; Kalisch et al, 2015; Kalisch et al, 2021). PASTOR theory conceptualizes resilience as an outcome: the maintenance of mental health after exposure to a stressor. The positive approach would no longer be measured as resilience, but as a resilience factor. She wants to capture the mechanism leading to this resilience.	Week 2, Week 14, Week 22