Quality of Life Clinical Trial
— RESPOND-FROfficial title:
Prevention of Mental Health Problems Among Persons Without Personal Housing in the Context of the COVID-19 Epidemic: a Randomized Controlled Trial
NCT number | NCT05033210 |
Other study ID # | ANRS0065s |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | October 2023 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Normandy Psychotrauma Center | Caen | Normandie |
France | CAPSYS | Paris | Île De France |
Lead Sponsor | Collaborator |
---|---|
ANRS, Emerging Infectious Diseases |
France,
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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 |
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