Psychosocial Impacts of the COVID-19 Pandemic Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | April 29, 2025 |
| Est. primary completion date | April 29, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 14 Years and older |
| Eligibility |
Inclusion Criteria: - General population Exclusion Criteria: - Not a resident of the province of Quebec - Age under 14 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | VITAM-Research Center in Sustainable Health | Québec |
| Lead Sponsor | Collaborator |
|---|---|
| Laval University | Centre de recherche CERVO, Centre de recherche intégrée pour un système apprenant en santé et services sociaux, Centre de recherche universitaire sur les jeunes et les familles, Centre intégré de santé et de services sociaux de la Côte-Nord, Centre intégré de santé et de services sociaux du Bas St-Laurent, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, CISSS de Chaudière-Appalaches, Fondation Mirella et Lino Saputo, Living Lab de Charlevoix, Participation sociale et villes inclusives, Regroupement des organismes de personnes handicapées de la région 03, Réseau international sur le Processus de production du handicap, Réseau provincial de recherche en adaptation réadaptation, Réseau québécois de recherche sur le vieillissement, Société inclusive, Ville de Québec, VITAM: Research Center on Sustainable Health |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Depression, Anxiety and Stress Scale-21 (DASS-21) | The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms. | Baseline (measured during lockdown in March 2020) | |
| Primary | Depression, Anxiety and Stress Scale-21 (DASS-21) | The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms. | 3 months | |
| Primary | Depression, Anxiety and Stress Scale-21 (DASS-21) | The DASS-21 is a measure of depression, anxiety and stress symptoms. The score on each subscale varies from 0 to 21. A higher score means a higher level of symptoms. | 7 months | |
| Primary | Insomnia Severity Index | Scores vary between 0 and 28. A higher score means greater insomnia severity. | Baseline (measured during lockdown in March 2020) | |
| Primary | Insomnia Severity Index | Scores vary between 0 and 28. A higher score means greater insomnia severity. | 3 months | |
| Primary | Insomnia Severity Index | Scores vary between 0 and 28. A higher score means greater insomnia severity. | 7 months | |
| Primary | Warwick-Edinburgh Mental Well-Being Scale | Scores range from 7 to 35 and higher scores indicate higher positive well-being. | Baseline (measured during lockdown in March 2020) | |
| Primary | Warwick-Edinburgh Mental Well-Being Scale | Scores range from 7 to 35 and higher scores indicate higher positive well-being. | 3 months | |
| Primary | Warwick-Edinburgh Mental Well-Being Scale | Scores range from 7 to 35 and higher scores indicate higher positive well-being. | 7 months | |
| Primary | Hostility subscale- Symptoms Checklist-90-Revised | Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility | Baseline (measured during lockdown in March 2020) | |
| Primary | Hostility subscale- Symptoms Checklist-90-Revised | Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility | 3 months | |
| Primary | Hostility subscale- Symptoms Checklist-90-Revised | Only the Hostility subscale that measures thoughts, feelings and actions characteristic of anger is used. Scores range from 6 to 24 and higher scores indicate higher level of hostility | 7 months | |
| Primary | Substance use | These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown. | Baseline (measured during lockdown in March 2020) | |
| Primary | Substance use | These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown. | 3 months | |
| Primary | Substance use | These are self-report questions that measure the change in consumption level of different substances such as alcool, prescriptions medications and illicit drugs prior and after the lockdown. | 7 months | |
| Primary | Brief COPE | We use a subset of questions taken from the Brief Cope which measures coping strategies. | Baseline (measured during lockdown in March 2020) | |
| Primary | Dyadic Adjustment Scale | We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction. | Baseline (measured during lockdown in March 2020) | |
| Primary | Parental Stress Index | We only use the Interaction subscale which measures the extent to which the parent believes the child is not meeting expectations and finds interactions with the child are not reinforcing his parenting role. | Baseline (measured during lockdown in March 2020) | |
| Primary | Child Conflict Tactic Scale | We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse. | Baseline (measured during lockdown in March 2020) | |
| Primary | Strengths and Difficulties Questionnaire | We use a subset of questions that aim to measure different child behaviors and personality caracteristics. | Baseline (measured during lockdown in March 2020) | |
| Primary | Healthcare workers adaptation | We use a series of questions that assess different changes that may have occured in their work, as well as a series of beliefs they may hold concerning their work and their patients/clients. | Baseline (measured during lockdown in March 2020) |