NCT04568135

Brief Summary

The primary objective of this survey study is to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. This survey study will utilize the Epidemic-Pandemic Impacts Inventory (EPII). This is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

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

First Submitted

Initial submission to the registry

September 18, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 31, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

September 18, 2020

Last Update Submit

October 12, 2020

Conditions

Keywords

surveycovid19Pre-Existing Mental Health Diagnosis

Outcome Measures

Primary Outcomes (1)

  • Survey: Epidemic-Pandemic Impacts Inventory (EPII)

    The Epidemic-Pandemic Impacts Inventory (EPII) is a newly tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains. Candidate items were constructed by a team of clinical and developmental psychologists with expertise in assessment of stress, trauma, resilience, and coping. Feedback from professionals across multiple disciplines (e.g., social work, pediatrics, medicine, anthropology) was incorporated in selecting and refining final items for of the measure, which was accomplished via expert consensus.

    one year

Study Arms (1)

survey

Other: survey

Interventions

surveyOTHER

survey

survey

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study is a survey study designed to assess the impact of the current COVID-19 pandemic on participants with psychiatric disorders to identify areas of needed support and services. This survey is an exploratory investigation of patient experience to guide Siyan in program improvement and development of next steps to serve patients.

You may qualify if:

  • Voluntarily agrees to participate in the study under their own free will and is willing/able to agree to an informed e-consent form indicating that he/she understands the purpose of the study, the procedures that are required for the study, and that he/she is willing to participate in the study.
  • Female or male and between the ages of 18 and 80, inclusive at the time of consent.
  • Is a currently receiving or has previously received psychiatric services from Siyan Clinical Corporation and/or Siyan Clinical Research practices.
  • Is capable of understanding and complying with study requirements.
  • Has agreed to the e-ICF. No study-related procedures will be performed before the participant has agreed to the consent letter.

You may not qualify if:

  • A known diagnosis of dementia will not be included in the sample.
  • Under the age of 18 or over the age of 80.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shah A, Darling M, Arstein-Kerslake O, Morgan T, Vance Tovrea A, Young J, Laines H. Measuring the Impact of COVID-19 on Siyan Mental Health Patients Using the Epidemic-Pandemic Impacts Inventory: Survey Study. JMIR Form Res. 2021 Jul 29;5(7):e29952. doi: 10.2196/29952.

MeSH Terms

Conditions

COVID-19

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2020

First Posted

September 29, 2020

Study Start

October 31, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share