Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen

Depression Clinical Trial

Official title:

Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04684615
• Other study ID #: 10000038
• Secondary ID: 000038-M
• Status: Enrolling by invitation
• Start date: December 28, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: January 19, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Active enrollment in Protocol 80-M-0083

2. 18 years of age and older.

EXCLUSION CRITERIA:

1. Under age 18.

INCLUSION OF VULNERABLE PARTICIPANTS:

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.

Related Conditions & MeSH terms

• Anxiety
• Bipolar Disorder
• COVID-19
• Depression

Locations

Country	Name	City	State
United States	National Institute of Mental Health (NIMH)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	assesses the stressors experienced as a result of the COVID-19 pandemic.
Secondary	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.	End of study