- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575571
MAVIPAN: My Life and the COVID-19 Pandemic
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:
- 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 Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Annie LeBlanc, PhD
- Phone Number: 418-663-5712
- Email: annie.leblanc@fmed.ulaval.ca
Study Contact Backup
- Name: Marie Baron, PhD
- Email: marie.baron.ciussscn@ssss.gouv.qc.ca
Study Locations
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Québec, Canada, G1J 0A4
- Recruiting
- VITAM-Research Center in Sustainable Health
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Contact:
- Annie LeBlanc, PhD
- Phone Number: 418-663-5712
- Email: annie.leblanc@fmed.ulaval.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- General population
Exclusion Criteria:
- Not a resident of the province of Quebec
- Age under 14
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: Baseline (measured during lockdown in March 2020)
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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.
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Baseline (measured during lockdown in March 2020)
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Depression, Anxiety and Stress Scale-21 (DASS-21)
Time Frame: 3 months
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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.
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3 months
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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.
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7 months
|
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Insomnia Severity Index
Time Frame: Baseline (measured during lockdown in March 2020)
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Scores vary between 0 and 28.
A higher score means greater insomnia severity.
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Baseline (measured during lockdown in March 2020)
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Insomnia Severity Index
Time Frame: 3 months
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Scores vary between 0 and 28.
A higher score means greater insomnia severity.
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3 months
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Insomnia Severity Index
Time Frame: 7 months
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Scores vary between 0 and 28.
A higher score means greater insomnia severity.
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7 months
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Warwick-Edinburgh Mental Well-Being Scale
Time Frame: Baseline (measured during lockdown in March 2020)
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Scores range from 7 to 35 and higher scores indicate higher positive well-being.
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Baseline (measured during lockdown in March 2020)
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Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 3 months
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Scores range from 7 to 35 and higher scores indicate higher positive well-being.
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3 months
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Warwick-Edinburgh Mental Well-Being Scale
Time Frame: 7 months
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Scores range from 7 to 35 and higher scores indicate higher positive well-being.
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7 months
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Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: Baseline (measured during lockdown in March 2020)
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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
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Baseline (measured during lockdown in March 2020)
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Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: 3 months
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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
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3 months
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Hostility subscale- Symptoms Checklist-90-Revised
Time Frame: 7 months
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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
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7 months
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Substance use
Time Frame: Baseline (measured during lockdown in March 2020)
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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.
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Baseline (measured during lockdown in March 2020)
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Substance use
Time Frame: 3 months
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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.
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3 months
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Substance use
Time Frame: 7 months
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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.
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7 months
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Brief COPE
Time Frame: Baseline (measured during lockdown in March 2020)
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We use a subset of questions taken from the Brief Cope which measures coping strategies.
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Baseline (measured during lockdown in March 2020)
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Dyadic Adjustment Scale
Time Frame: Baseline (measured during lockdown in March 2020)
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We use a subset of questions taken from the Dyadic Adjustment Scale which measures couple satisfaction.
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Baseline (measured during lockdown in March 2020)
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Parental Stress Index
Time Frame: Baseline (measured during lockdown in March 2020)
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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.
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Baseline (measured during lockdown in March 2020)
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Child Conflict Tactic Scale
Time Frame: Baseline (measured during lockdown in March 2020)
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We use a subset of questions that measures the presence of minor physical abuse as well as psychological abuse.
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Baseline (measured during lockdown in March 2020)
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Strengths and Difficulties Questionnaire
Time Frame: Baseline (measured during lockdown in March 2020)
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We use a subset of questions that aim to measure different child behaviors and personality caracteristics.
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Baseline (measured during lockdown in March 2020)
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Healthcare workers adaptation
Time Frame: Baseline (measured during lockdown in March 2020)
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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.
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Baseline (measured during lockdown in March 2020)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Annie LeBlanc, PhD, Faculty of Medecine, Laval University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- To be assigned (EGMS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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