NCT04684615Completed
Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 193 (actual)
- First submitted
- 23 Dec 2020
- Start date
- 28 Dec 2020
- Primary completion date
- 15 May 2025
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Diseases
- Bipolar disorder
- NCT number
- NCT04684615
What you commit to
- Study type: Observational
- Participants enrolled: 193
- From 28 Dec 2020 to the primary completion date, 15 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The study will be not be targeting any vulnerable populations. We are not planning to recruit children; all participants being invited to participate have previously been assessed under Protocol 80-M-0083 as over the age of 18.
Age
- 1\. Under age 18.
Other
- INCLUSION OF VULNERABLE PARTICIPANTS:
Criteria the registry did not label
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Active enrollment in Protocol 80-M-0083
- 18 years of age and older.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Mental Health (NIMH) Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.