Stress, Coping, and Sleep Health Study

November 3, 2026 updated by: National Institute of Environmental Health Sciences (NIEHS)

Background:

Poor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes.

Objective:

To learn how the social and environmental conditions Bhutanese refugees affect their sleep health and health outcomes.

Eligibility:

Refugees aged 18 years and older of Bhutanese-Nepali or Bhutanese American descent. The participants must live in central Ohio. Also needed are people aged 18 years and older who interact with Bhutanese refugees in this region.

Design:

Participants will participate in a focus group discussion. The group will have 8 to 10 participants. It will last 60 to 90 minutes.

They will talk about their experiences as a refugee and their sleep health. Topics may include adjusting to a new culture; access to housing and health care; and experiences with differential treatment by members inside and outside of their group. The study team will audio record the discussion. They will not share the recording with anyone.

Participants will complete a short questionnaire. They will answer questions about their age, sex, language preferences, and how long they have lived in the United States.

Participants who are not refugees will take part in a virtual interview led by a member of the study team. Participants will share their experiences with adapting to a new culture, differential treatment, and other factors have affected refugees sleep. The interview will take about 1 hour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Study Description:

This qualitative study seeks to examine the role of discrimination, acculturative stressors, and coping mechanisms in shaping the sleep health of Bhutanese refugees living in Central Ohio. Using focus group discussions (n=approximately 6) with Bhutanese refugees and key informant interviews (n=approximately 10) with community leaders, the study will examine associations between refugee-related stressors-such as trauma, discrimination, and acculturation challenges-and sleep health. It will also explore coping strategies employed in response to sleep difficulties, experiences of discrimination, and other stressors, and identify recommendations for enhanced community resources and support.

Objectives:

The primary objectives of this study include:

  1. Investigate associations between stressors related to being a refugee (e.g., trauma, financial strain, discrimination, acculturation, political) and various sleep health dimensions.
  2. Identify coping strategies used in response to difficulties with sleep, discriminatory experiences, and other stressors.
  3. Determine recommendations regarding the types of support and resources needed by the Bhutanese refugee community to manage stressors and support sleep health.

Endpoints:

We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data contain sufficient depth, diversity of perspectives, and contextual detail to fully address our central research questions. This assessment will involve triangulation, using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43229
        • Bhutanese Community of Central Ohio
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will enroll between 48-60 adults (18+ years) living in Ohio, US for Focus Group Discussions and 10 adults (18+ years) who work with or support Bhutanese Refugees living in Ohio.

Description

  • INCLUSION CRITERIA:

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

  1. Adult (aged 18 years or older) living in Ohio, US
  2. Self-identify as Bhutanese-Nepali or Bhutanese American
  3. Identify as a refugee
  4. Speak and understand English and/or Nepali.
  5. Ability to understand and the willingness to provide informed consent and participate in the FGD

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

  1. Adult (aged 18 years or older)
  2. Ability to speak and understand English; Familiarity with the lives and experiences of Bhutanese refugees living in Ohio, US
  3. Ability to understand and the willingness to provide informed consent and participate in the virtual KII.

EXCLUSION CRITERIA:

Individuals who are unable to communicate in either English or Nepali will be excluded from FGD. Since Nepali is the primary language spoken by most Bhutanese refugees before relocation, and English is the dominant language in the United States, participants are expected to have sufficient proficiency in at least one of these languages.

Individuals who are unable to communicate in English will be excluded from KII. Given their leadership roles and interactions with the healthcare system, educational institutions, local government service providers, and nonprofit organizations in Ohio-where English is the primary language-participants are expected to have sufficient English proficiency. We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures.

Children (individuals under 18) are excluded from this study because the knowledge sought is not relevant to this population. This study investigates the relationship between sleep quality and experiences of discrimination among Bhutanese-Nepali refugees in Ohio, as well as the coping mechanisms adults use to manage discrimination-related stress, particularly as it pertains to sleep.

The constructs under investigation, including perceived discrimination, its psychosocial impact, and adaptive coping strategies, are anchored in the adult experience of resettlement and the stressors associated with adult social and occupational life. Children's experiences of discrimination, sleep patterns, and coping mechanisms differ substantially from those of adults in both nature and context, and findings from an adult sample would not be generalizable to a pediatric population. For these reasons, the inclusion of children would not yield scientifically meaningful data relevant to the study aims.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: ECOLOGIC_OR_COMMUNITY
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
US Bhutanese

Those self-identifying as Bhutanese living in central Ohio.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Investigate associations between stressors related to being a refugee (e.g., trauma, financial strain, discrimination, acculturation, political) and various sleep health dimensions.
Time Frame: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence
Will use qualitative best practices to determine when study objectives have been sufficiently achieved.
Identify coping strategies used in response to difficulties with sleep, discriminatory experiences, and other stressors.
Time Frame: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence
Will use qualitative best practices to determine when study objectives have been sufficiently achieved.
Determine recommendations regarding the types of support and resources needed by the Bhutanese refugee community to manage stressors and support sleep health.
Time Frame: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence
Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Environmental Health Sciences (NIEHS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chandra L Jackson, Ph.D., National Institute of Environmental Health Sciences (NIEHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 3, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10002390
  • 002390-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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