Clinical trial NCT04575571: MAVIPAN: My Life and the COVID-19 Pandemic
Official title: The MAVIPAN Protocol: For a Structured Response to the Psychosocial Consequences of the Restrictive Measures Imposed by the Global Health COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychosocial Impacts of the COVID-19 Pandemic
Keywords: Psychological Distress
Coping Behaviors
Covid19
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: VITAM: Research Center on Sustainable Health
name: Centre de recherche CERVO
name: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
name: Centre de recherche universitaire sur les jeunes et les familles
name: Réseau québécois de recherche sur le vieillissement
name: Participation sociale et villes inclusives
name: Société inclusive
name: CISSS de Chaudière-Appalaches
name: Centre intégré de santé et de services sociaux de la Côte-Nord
name: Fondation Mirella et Lino Saputo
name: Ville de Québec
name: Living Lab de Charlevoix
name: Centre intégré de santé et de services sociaux du Bas St-Laurent
name: Réseau provincial de recherche en adaptation réadaptation
name: Réseau international sur le Processus de production du handicap
name: Centre de recherche intégrée pour un système apprenant en santé et services sociaux
name: Regroupement des organismes de personnes handicapées de la région 03
First posted: 2020-10-05
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MAVIPAN is open to any individuals aged 14 and over across the Province of Quebec. We are particularly invested in recruiting vulnerable populations (e.g., older adults, individuals living with a disability or a chronic or mental health condition, child protection families, individuals living in institutional settings) and populations that have become vulnerable because of the COVID-19 context (e.g., healthcare and social services workers, adolescents, caregivers).

Brief summary: The health crisis imposed by COVID-19 is forcing major worldwide social reorganization that will have profound consequences on our society. Currently, one-third of the world's population (\~3 billion individuals) is living under some kind of isolation or quarantine measures, causing an unprecedented and rapidly evolving psychosocial crisis.

The psychosocial consequences of this health crisis will persist long after restriction measures are lifted and the pandemic is over. This impact will be significant for individuals facing unique contexts or challenges (e.g., older adults, individuals living with a disability, underprivileged families) and will most likely exacerbate existing social and gender inequalities in health and human development.

There is an urgent need for information on the evolution of the psychosocial dimensions of health and coping strategies used by our population and our health and social services structures. Thus, this study is designed to accelerate the availability of high-quality, real-time evidence within health and social services structures to address, support and minimize psychosocial consequences of the COVID-19 pandemic. Through constantly evolving research questions responsive to the course of the pandemic evolution, the rapid system transformations and adaptation of services, and knowledge users (KUs) needs, MAVIPAN aims to address, document, monitor, and evaluate the following:

1. Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts.
2. Healthcare and social services workers and managers' adjustments and mitigation strategies.
3. The organization of service structures.
4. The social and economic response.

To achieve these objectives, we use a mixed methods study design that combines quantitative questionnaires and qualitative interviews to deepen our understanding of elements such as the coping strategies used during the pandemic. A first measure was taken during lock-down as well as a follow-up at 3 months. Another follow-up will be made at 7 months. At least one per year follow-up will be made over the course of the study (5 years). Additional measures may be taken depending on the evolution of the pandemic and the sanitary measures put in place by the authorities.


Eligibility criteria: Inclusion Criteria:

* General population

Exclusion Criteria:

* Not a resident of the province of Quebec
* Age under 14

Primary outcomes:
measure: Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: 3 months
measure: Depression, Anxiety and Stress Scale-21 (DASS-21)
timeFrame: 7 months
measure: Insomnia Severity Index
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Insomnia Severity Index
timeFrame: 3 months
measure: Insomnia Severity Index
timeFrame: 7 months
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 3 months
measure: Warwick-Edinburgh Mental Well-Being Scale
timeFrame: 7 months
measure: Hostility subscale- Symptoms Checklist-90-Revised
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Hostility subscale- Symptoms Checklist-90-Revised
timeFrame: 3 months
measure: Hostility subscale- Symptoms Checklist-90-Revised
timeFrame: 7 months
measure: Substance use
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Substance use
timeFrame: 3 months
measure: Substance use
timeFrame: 7 months
measure: Brief COPE
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Dyadic Adjustment Scale
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Parental Stress Index
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Child Conflict Tactic Scale
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Strengths and Difficulties Questionnaire
timeFrame: Baseline (measured during lockdown in March 2020)
measure: Healthcare workers adaptation
timeFrame: Baseline (measured during lockdown in March 2020)
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: VITAM-Research Center in Sustainable Health
Study officials:
affiliation: Faculty of Medecine, Laval University
name: Annie LeBlanc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBlanc A, Baron M, Blouin P, Tarabulsy G, Routhier F, Mercier C, Despres JP, Hebert M, De Koninck Y, Cellard C, Collin-Vezina D, Cote N, Dionne E, Fleet R, Gagne MH, Isabelle M, Lessard L, Menear M, Merette C, Ouellet MC, Roy MA, Saint-Jacques MC, Savard C; MAVIPAN Research Collaboration. For a structured response to the psychosocial consequences of the restrictive measures imposed by the global COVID-19 health pandemic: the MAVIPAN longitudinal prospective cohort study protocol. BMJ Open. 2022 Apr 4;12(4):e048749. doi: 10.1136/bmjopen-2021-048749.