CClinicalTrials.gg
Status unknownNCT04568135Updated Oct 14, 2020

A Survey Study to Assess the Impact of the COVID-19 Pandemic on Participants With Pre-Existing Mental Health Diagnosis

An observational study in Covid19, sponsored by Siyan Clinical Corporation. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Siyan Clinical Corporation · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

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. A one-time survey will be sent out electronically via email to approximately 3,500 adult patients in the Siyan Clinical Corporation and Siyan Clinical Research practices. The survey will consist of the Epidemic-Pandemic Impacts Inventory (EPII). This is a new tool designed to assess tangible impacts of epidemics and pandemics across personal and social life domains.

Siyan staff will derive a list of patients from the Siyan EHR who meet eligibility criteria. The list will include Patient ID, age, gender, ethnicity, occupation, employment status, primary diagnosis, and last known email address. Each patient in the sample will receive an email inviting them to participate in the survey, explaining the purpose of the survey, how Siyan will use the survey results, and how the survey will be administered. All patients in the sample who have not responded will also receive a reminder email approximately one week later. Each e-mail will include information to contact the Investigator with any questions.

Patients that reply to the initial invitation will receive the electronic Informed Consent Form (eICF) to sign and return to the Project Coordinator via Adobe Sign. The Project Coordinator will track the name and email address of all patients who consent to participate, and will send each a link to the online survey in SurveyGizmo. https://www.surveygizmo.com/s3/5751791/Siyan-COVIDImpactSurvey) The online survey will repeat the text of the electronic Informed Consent Form (eICF), allowing participants to again confirm agreement and continue the survey or disagree and exit out. Participants who agree to the consent will be asked to confirm their email address, and respond to the 92 questions in the EPII about how the coronavirus disease pandemic has changed their and/or their family's lives. Respondents will also be asked basic demographic questions: age, gender identity, ethnicity, education level, employment status, industry, children under 18 in the home, marital status, and experience with basic psychiatric disorders.

The evaluation consultant will tabulate responses and provide basic frequencies and analyses to the Investigator, along with a de-identified dataset for further advanced analysis. Data collected may serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19. Analysis of data collected will be published in academic journals to serve as a foundational research in the prevention, care and treatment of mental health disorders during pandemics such as COVID-19.

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Conditions studied

  • Covid19

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Keywords

  • survey
  • covid19
  • Pre-Existing Mental Health Diagnosis
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Siyan Clinical Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • survey

    Other: survey

Interventions

  • Othersurvey

    survey

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What researchers measure

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.

    Time frame: one year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 34323851 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04568135
Lead sponsor
Siyan Clinical Corporation
Responsible party
Sponsor
First posted
Sep 29, 2020
Start date
Oct 31, 2020 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Oct 14, 2020

Study contacts

Tiffany Morgan
Contact
tmorgan@siyanclinical.com
707-206-7268

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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