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Not yet recruiting NCT07566481

Stress, Coping, and Sleep Health Study

Observational Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

  • INCLUSION CRITERIA:

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

  • Adult (aged 18 years or older) living in Ohio, US
  • Self-identify as Bhutanese-Nepali or Bhutanese American
  • Identify as a refugee
  • Speak and understand English and/or Nepali.
  • 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:

  • Adult (aged 18 years or older)
  • Ability to speak and understand English; Familiarity with the lives and experiences of Bhutanese refugees living in Ohio, US
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Bhutanese Community of Central Ohio — Columbus

Publications

  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2. PMID 34785096
  • Patton MQ. Enhancing the quality and credibility of qualitative analysis. Health Serv Res. 1999 Dec;34(5 Pt 2):1189-208. PMID 10591279
  • Misra SM, Nepal VP, Banerjee D, Giardino AP. Chronic Health Conditions, Physical Activity and Dietary Behaviors of Bhutanese Refugees: A Houston-Based Needs Assessment. J Immigr Minor Health. 2016 Dec;18(6):1423-1431. doi: 10.1007/s10903-015-0282-1. PMID 26458956
  • Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8. PMID 32801085
  • Scott AJ, Webb TL, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. Epub 2021 Sep 23. PMID 34607184
  • Jou YC, Pace-Schott EF. Call to action: Addressing sleep disturbances, a hallmark symptom of PTSD, for refugees, asylum seekers, and internally displaced persons. Sleep Health. 2022 Dec;8(6):593-600. doi: 10.1016/j.sleh.2022.09.003. Epub 2022 Oct 27. PMID 36511279
  • Lies J, Mellor A, Jobson L, Drummond SPA. Prevalence of sleep disturbance and its relationships with mental health and psychosocial issues in refugees and asylum seekers attending psychological services in Australia. Sleep Health. 2019 Aug;5(4):335-343. doi: 10.1016/j.sleh.2019.06.002. Epub 2019 Jul 16. PMID 31320291
  • Lies J, Drummond SPA, Jobson L. Longitudinal investigation of the relationships between trauma exposure, post-migration stress, sleep disturbance, and mental health in Syrian refugees. Eur J Psychotraumatol. 2020 Nov 19;11(1):1825166. doi: 10.1080/20008198.2020.1825166. PMID 33425241

Identifiers

NCT: NCT07566481 · 10002390 · 002390-E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗