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NCT04684615 · ClinicalTrials.gov registry record
Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 193
- Enrollment target
NCT04684615: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT04684615 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 193 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04684615 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 193 participants
- Enrollment target
Study Summary
People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to health care. Their lifestyle is based on interaction and group events rather than technology. So people in Amish and Mennonite communities may experience the pandemic in their own special ways. Objective: To describe the relationship between stress related to the pandemic and self-rated measures of mental health symptoms and distress among Amish and Mennonite people with bipolar disorder and related conditions, and their family members. Eligibility: Adults ages 18 and older who are taking part in the NIMH AMBiGen study (80-M-0083). Design: Participants will be mailed 4 surveys. One survey will ask about depression symptoms. One survey will ask about mania symptoms. One survey will assess a broad range of psychological problems. One survey will assess the impact of COVID-19 on their mental health. They will fill out the surveys 4 times over 24 months. The surveys will not include participants names, just codes. This will help protect privacy. Data collected in 80-M-0083 will be used. This includes data about participants genes, medical conditions, and assessments. Participants will get an 800 number they can call to speak to the research team. They can also write to the team if they prefer. Participants who wish will get referrals for mental health services. Participation will last up to 24 months. There will be an option for recontact in the future.
Primary Outcome
The availability of repeated measurement will allow us to establish whether changes in stressors related to COVID-19 are associated with changes in mental health symptoms and distress within subject.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2020-12-28 |
| Est. Completion | 2025-05-15 |
What the finished NCT04684615 record still lists
NCT04684615 is an observational study that tracks outcomes without assigning an intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04684615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04684615 about?
NCT04684615 is a clinical study titled "Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen". People have had to make a lot of changes to their lives due to the COVID-19 health crisis. Most experts agree that social distancing and other safety measures have taken a toll on people s mental health. Amish and Mennonite communities often have large families. They may have limited access to healt...
What is the current status of trial NCT04684615?
This trial is currently completed. The enrollment target is 193 participants. The study started on 2020-12-28. Estimated completion is 2025-05-15.
Who is sponsoring clinical trial NCT04684615?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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