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

Sponsor
National Institute of Mental Health (NIMH) (NIH)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04684615
Collaborator
(none)
1,000
Enrollment
1
Location
9.3
Anticipated Duration (Months)
107.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen
    Anticipated Study Start Date :
    Oct 20, 2021
    Anticipated Primary Completion Date :
    Jul 31, 2022
    Anticipated Study Completion Date :
    Jul 31, 2022

    Arms and Interventions

    ArmIntervention/Treatment
    AmBiGen

    Individuals who are enrolled in AmBiGen over the last 3 years

    Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    Secondary Outcome Measures

    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... [End of study]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institute of Mental Health (NIMH)BethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Francis J McMahon, M.D., National Institute of Mental Health (NIMH)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Mental Health (NIMH)
    ClinicalTrials.gov Identifier:
    NCT04684615
    Other Study ID Numbers:
    • 10000038
    • 000038-M
    First Posted:
    Dec 24, 2020
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Jul 19, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Institute of Mental Health (NIMH)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2021