NCT04575571

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 29, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

September 24, 2020

Last Update Submit

October 2, 2020

Conditions

Keywords

Psychological DistressCoping BehaviorsCovid19

Outcome Measures

Primary Outcomes (21)

  • 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)

  • 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

  • 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

  • Insomnia Severity Index

    Scores vary between 0 and 28. A higher score means greater insomnia severity.

    Baseline (measured during lockdown in March 2020)

  • Insomnia Severity Index

    Scores vary between 0 and 28. A higher score means greater insomnia severity.

    3 months

  • Insomnia Severity Index

    Scores vary between 0 and 28. A higher score means greater insomnia severity.

    7 months

  • 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)

  • Warwick-Edinburgh Mental Well-Being Scale

    Scores range from 7 to 35 and higher scores indicate higher positive well-being.

    3 months

  • Warwick-Edinburgh Mental Well-Being Scale

    Scores range from 7 to 35 and higher scores indicate higher positive well-being.

    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

    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

    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

    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.

    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.

    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.

    7 months

  • Brief COPE

    We use a subset of questions taken from the Brief Cope which measures coping strategies.

    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.

    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.

    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.

    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.

    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.

    Baseline (measured during lockdown in March 2020)

Interventions

No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • General population

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VITAM-Research Center in Sustainable Health

Québec, G1J 0A4, Canada

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Annie LeBlanc, PhD

    Faculty of Medecine, Laval University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 5, 2020

Study Start

April 29, 2020

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations