Psychosocial Impacts of the COVID-19 PandemicNCT04575571
MAVIPAN: My Life and the COVID-19 Pandemic
An observational study of Psychosocial Impacts of the COVID-19 Pandemic, run by Laval University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychosocial Impacts of the COVID-19 Pandemic
- How many people
- 5,000 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2020to 29 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- General population
Who cannot join
- Not a resident of the province of Quebec
- Age under 14
Trial locations and contacts
1 site in 1 country.
Marie Baron, PhD contact
Canada1 site, 1 recruiting
- Recruiting
VITAM-Research Center in Sustainable Health
Québec, G1J 0A4
Annie LeBlanc, PhD, 418-663-5712, annie.leblanc@fmed.ulaval.ca
About this study
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.
Read more
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:
- Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts.
- Healthcare and social services workers and managers' adjustments and mitigation strategies.
- The organization of service structures.
- 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.
- Being tested
- No intervention, this is an observational study that uses validated questionnaires and qualitative interviews..
- Keywords
- Psychological Distress, Coping Behaviors, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, this is an observational study that uses validated questionnaires and qualitative interviews..Other
No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (measured during lockdown in March 2020)
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.
Measured: 3 months
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.
Measured: 7 months
Insomnia Severity Index
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Measured: Baseline (measured during lockdown in March 2020)
Insomnia Severity Index
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Measured: 3 months
Insomnia Severity Index
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Measured: 7 months
Warwick-Edinburgh Mental Well-Being Scale
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Measured: Baseline (measured during lockdown in March 2020)
Warwick-Edinburgh Mental Well-Being Scale
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Measured: 3 months
Warwick-Edinburgh Mental Well-Being Scale
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Measured: 7 months
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
Measured: Baseline (measured during lockdown in March 2020)
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
Measured: 3 months
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
Measured: 7 months
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.
Measured: Baseline (measured during lockdown in March 2020)
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.
Measured: 3 months
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.
Measured: 7 months
Brief COPE
We use a subset of questions taken from the Brief Cope which measures coping strategies.
Measured: Baseline (measured during lockdown in March 2020)
Dyadic Adjustment Scale
We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction.
Measured: Baseline (measured during lockdown in March 2020)
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.
Measured: Baseline (measured during lockdown in March 2020)
Child Conflict Tactic Scale
We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse.
Measured: Baseline (measured during lockdown in March 2020)
Strengths and Difficulties Questionnaire
We use a subset of questions that aim to measure different child behaviors and personality caracteristics.
Measured: Baseline (measured during lockdown in March 2020)
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.
Measured: Baseline (measured during lockdown in March 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start29 Apr 2020
- Primary completion29 Apr 2025 (estimated)
- Study completion29 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychosocial Impacts of the COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- VITAM: Research Center on Sustainable Health, Centre de recherche CERVO, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Centre de recherche universitaire sur les jeunes et les familles, Réseau québécois de recherche sur le vieillissement, Participation sociale et villes inclusives, Société inclusive, CISSS de Chaudière-Appalaches, Centre intégré de santé et de services sociaux de la Côte-Nord, Fondation Mirella et Lino Saputo, Ville de Québec, Living Lab de Charlevoix, Centre intégré de santé et de services sociaux du Bas St-Laurent, Réseau provincial de recherche en adaptation réadaptation, Réseau international sur le Processus de production du handicap, Centre de recherche intégrée pour un système apprenant en santé et services sociaux, Regroupement des organismes de personnes handicapées de la région 03
- Responsible party
- Principal investigator, Annie Leblanc, Laval University
- Investigators
- Annie LeBlanc, PhD, Principal investigator, Faculty of Medecine, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575571
- Sponsor's protocol ID
- To be assigned
- Status last verified
- Oct 2020
- First submitted
- 24 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35379610
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04575571
- Acronym / sponsor ID
- To be assigned
- Keywords
- Psychological Distress, Coping Behaviors, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- VITAM: Research Center on Sustainable Health, Centre de recherche CERVO, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale, Centre de recherche universitaire sur les jeunes et les familles, Réseau québécois de recherche sur le vieillissement, Participation sociale et villes inclusives, Société inclusive, CISSS de Chaudière-Appalaches, Centre intégré de santé et de services sociaux de la Côte-Nord, Fondation Mirella et Lino Saputo, Ville de Québec, Living Lab de Charlevoix, Centre intégré de santé et de services sociaux du Bas St-Laurent, Réseau provincial de recherche en adaptation réadaptation, Réseau international sur le Processus de production du handicap, Centre de recherche intégrée pour un système apprenant en santé et services sociaux, Regroupement des organismes de personnes handicapées de la région 03
- Study start
- 29 Apr 2020 (actual)
- Primary completion
- 29 Apr 2025 (estimated)
- Study completion
- 29 Apr 2025 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Individuals and families' adjustments and mitigation strategies, especially for those considered vulnerable and in high-risk contexts.
- Healthcare and social services workers and managers' adjustments and mitigation strategies.
- The organization of service structures.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- General population
Key exclusion criteria (2 listed)
- Not a resident of the province of Quebec
- Age under 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, this is an observational study that uses validated questionnaires and qualitative interviews..No intervention, this is an observational study that uses validated questionnaires and qualitative interviews. | Other | – |
Primary outcome
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: Baseline (measured during lockdown in March 2020)
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.
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: 3 months
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.
Depression, Anxiety and Stress Scale-21 (DASS-21)
Time frame: 7 months
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.
Insomnia Severity Index
Time frame: Baseline (measured during lockdown in March 2020)
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Insomnia Severity Index
Time frame: 3 months
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Insomnia Severity Index
Time frame: 7 months
Scores vary between 0 and 28. A higher score means greater insomnia severity.
Warwick-Edinburgh Mental Well-Being Scale
Time frame: Baseline (measured during lockdown in March 2020)
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Warwick-Edinburgh Mental Well-Being Scale
Time frame: 3 months
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Warwick-Edinburgh Mental Well-Being Scale
Time frame: 7 months
Scores range from 7 to 35 and higher scores indicate higher positive well-being.
Hostility subscale- Symptoms Checklist-90-Revised
Time frame: Baseline (measured during lockdown in March 2020)
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
Hostility subscale- Symptoms Checklist-90-Revised
Time frame: 3 months
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
Hostility subscale- Symptoms Checklist-90-Revised
Time frame: 7 months
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
Substance use
Time frame: Baseline (measured during lockdown in March 2020)
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.
Substance use
Time frame: 3 months
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.
Substance use
Time frame: 7 months
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.
Brief COPE
Time frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions taken from the Brief Cope which measures coping strategies.
Dyadic Adjustment Scale
Time frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction.
Parental Stress Index
Time frame: Baseline (measured during lockdown in March 2020)
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.
Child Conflict Tactic Scale
Time frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse.
Strengths and Difficulties Questionnaire
Time frame: Baseline (measured during lockdown in March 2020)
We use a subset of questions that aim to measure different child behaviors and personality caracteristics.
Healthcare workers adaptation
Time frame: Baseline (measured during lockdown in March 2020)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 35379610LeBlanc 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.
- Official web site of the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Baron, PhD contact
Annie LeBlanc, PhD principal investigator
Faculty of Medecine, Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosocial Impacts of the COVID-19 Pandemic, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie LeBlanc, PhD (418-663-5712, annie.leblanc@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scale-21 (DASS-21) (time frame: Baseline (measured during lockdown in March 2020)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.