DepressionNCT04684615
Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
An observational study of Depression and Anxiety, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Bipolar Disorder
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample size will be up to 1,000 and will include participants 18 years and older of both sexes, any gender, and health status. This sample size is an estimate of the number of individuals who have enrolled the NIMH AmBiGen study in the past and might respond if re-contacted, as well as family members who may not have enrolled in the past but are expected to share genetic, familial, and community risk/resilience factors.
Who may be able to join
- 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.
- 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.
Who cannot join
- 1. Under age 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Mental Health (NIMH)
Bethesda, Maryland, 20892
About this study
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:
Read more
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.
Read the detailed description
This protocol leverages existing NIMH studies and participants to accomplish time-sensitive research on the mental health impact of environmental stressors imposed by the COVID-19 pandemic. The study will describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among Amish and Mennonite participants in an ongoing study of bipolar disorder (AMBiGen), and their family members.
Objectives: The primary objective is to describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among individuals with bipolar disorder, related conditions, and their family members. The secondary objectives are to determine the roles played by psychiatric diagnosis, genetic risk of various mental illnesses, and perceived social support in moderating risk and resilience for mental health during and after the COVID-19 pandemic.
- Conditions
- Depression, Anxiety, Bipolar Disorder
- Keywords
- Anabaptist, Coronavirus, behavioral health, Mood Disorder, Natural History
- Medical subject headings
- Depression, Anxiety Disorders, Bipolar Disorder, Coronavirus Infections, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AmBiGen | Individuals who are enrolled in AmBiGen over the last 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers.
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.
Measured: assesses the stressors experienced as a result of the COVID-19 pandemic.
Secondary outcomes (1)
1) Determine whether existing mental health concerns moderates the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress. 2) To identify risk and resilience factors among study particip...
In order to determine whether the participant has existing mental health concerns, we must collect information on a variety of symptoms related to mental health. We hypothesize that certain participant- level characteristics may be related to the mental health and behavioral impacts of the COVID-19 pandemic. For this exploratory aim, we will evaluate a variety of sociodemographic, clinical, genetic, and behavioral variables.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start28 Dec 2020
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Francis J McMahon, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684615
- Sponsor's protocol ID
- 10000038
- Other IDs
- 000038-M
- Status last verified
- May 2026
- First submitted
- 23 Dec 2020
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
- ClinicalTrials.gov ID
- NCT04684615
- Acronym / sponsor ID
- 10000038
- Conditions
- Depression, Anxiety, Bipolar Disorder
- Keywords
- Anabaptist, Coronavirus, behavioral health, Mood Disorder, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This protocol leverages existing NIMH studies and participants to accomplish time-sensitive research on the mental health impact of environmental stressors imposed by the COVID-19 pandemic. The study will describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among Amish and Mennonite participants in an ongoing study of bipolar disorder (AMBiGen), and their family members.
Objectives: The primary objective is to describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among individuals with bipolar disorder, related conditions, and their family members. The secondary objectives are to determine the roles played by psychiatric diagnosis, genetic risk of various mental illnesses, and perceived social support in moderating risk and resilience for mental health during and after the COVID-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AmBiGen | – | –Individuals who are enrolled in AmBiGen over the last 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size will be up to 1,000 and will include participants 18 years and older of both sexes, any gender, and health status. This sample size is an estimate of the number of individuals who have enrolled the NIMH AmBiGen study in the past and might respond if re-contacted, as well as family members who may not have enrolled in the past but are expected to share genetic, familial, and community risk/resilience factors.
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 1. Under age 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers.
Time frame: assesses the stressors experienced as a result of the COVID-19 pandemic.
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.
1 secondary outcome
1) Determine whether existing mental health concerns moderates the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress. 2) To identify risk and resilience factors among study particip...
Time frame: End of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis J McMahon, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. (time frame: assesses the stressors experienced as a result of the COVID-19 pandemic.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.