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Health and Quality of Life Among Resettled Syrians in Norway (REFUGE-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03742128
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
Norwegian Institute of Public Health
Inland Norway University of Applied Sciences
Swedish Red Cross University College
Karolinska Institutet
Information provided by (Responsible Party):
Norwegian Center for Violence and Traumatic Stress Studies

Brief Summary:

Brief summary The civil war in Syria has taken a severe toll on the Syrian population, with over 350 000 dead and more than 10 million Syrians forced to leave their home since 2011. The majority of the estimated 5.6 million Syrians who have left the country as refugees currently reside in Syria's neighboring countries (Turkey, Jordan and Lebanon), while about 1 million have fled to Europe. In the peak year of 2015, a little over 10500 Syrians applied for asylum in Norway and an estimated 26 000 lived in the country at the start of 2018 according to statistics from the Norwegian Directorate of Immigration.

Being a refugee or resettled refugee is psychologically stressful and increases the risk of ill mental health. Prior research has demonstrated high to very high levels of posttraumatic stress disorder (PTSD), depression and anxiety in refugees compared to normal populations. As highlighted in prior review articles on the subject, there is a lack of studies on refugees originating from the Middle Eastern countries, and there is a need for future studies on refugee mental health to move beyond the focus on PTSD, depression and anxiety in order to capture the wider psychological consequences associated with being a refugee or resettled refugee. With the current number of displaced people globally approaching an unprecedented 70 million, including more than 25 million refugees, the need to understand and address the health challenges in this population is more pressing than ever.

The present study, REFUGE-I, constitutes the first phase of a planned longitudinal cohort study (REFUGE-study) on health and quality of life among resettled Syrian refugees in Norway. The overarching aims of REFUGE-I are to recruit a representative sample of Syrian adults who are willing to participate in the longitudinal cohort study and to obtain baseline information on health-related topics as well as demographics for this recruited sample.

REFUGE-I will use a cross-sectional survey design. The study population will be a random and representative sample of 10 000 Syrians over 18 years who arrived in Norway between 2015 and 2017, and who currently live and have a registered residential address in Norway. The sampled group will be contacted and informed about the study through postal mail. Information about the study will also be distributed through other channels: regular media (e.g. television and newspapers), social media (e.g. Facebook), District Medical Doctors/Public Health Officers, and a study web-page with more detailed information on the study including instructive animation videos in Arabic. Those consenting to participate will be asked to fill out and return a postal survey questionnaire on demographics and health-related topics focusing on:

Symptoms of posttraumatic stress, anxiety and depression Quality of life Self-reported physical health (focusing on subjective pain) Sleep difficulties and alcohol consumption patterns Social support Potentially traumatic experiences before or during the flight from Syria Stress experienced after arrival in Norway (post-migratory stress)

Participants will also be asked whether the research group can contact them again for the second and third phase of the longitudinal study, and informed that consent to participation entails consent that survey data will be linked to Norwegian registry data on education, work participation and sick-leave, drug prescriptions and utilization of the health-care system. The registry data will be linked to survey data in the later phases of the larger longitudinal study.

The main objective of the REFUGE-I study is to obtain and publish a thorough cohort profile that includes descriptive statistics for the final sample on the above-listed health-related topics, as well as information and statistics on potential selection bias issues that might affect the generalizability of findings.

The study is a collaborative effort between five research institutions and universities in Norway and Sweden. One of the collaborating partners, The Swedish Red Cross University College, has already conducted a similar study on 1215 resettled adult Syrian refugees in Sweden, and results from REFUGE-I will be compared to the findings from the Swedish study. Moreover, an important long-term goal for the larger REFUGE-study is to help advance research on refugees by making resources from the study available online, and through the creation of a large database containing pooled data from the REFUGE-study and studies done through the Swedish Red Cross University College and potentially other national and international research groups.


Condition or disease
Mental Health Impairment Stress, Psychological Quality of Life Health, Subjective Posttraumatic Stress Disorder Anxiety Depression

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The REFUGE-study: Health and Quality of Life Among Resettled Syrian Refugees and Asylum-seekers in Norway (REFUGE-I)
Estimated Study Start Date : November 27, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019



Primary Outcome Measures :
  1. Harvard Trauma Questionnaire (HTQ) [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]

    The first 16 items in the section on trauma symptoms (section IV) in the HTQ will be used to measure symptoms of posttraumatic stress disorder (PTSD) (Mollica et al., 1992; Shoeb, Weinstein, & Mollica, 2007). The selected 16 items are based on the criteria for PTSD diagnosis in the American Psychiatric Association's Diagnostic and Statistical Manual of mental disorders, version IV (DSM-IV). All 16 items have four categorical responses: Not at all; A little; Quite a bit; and Extremely; scored on a Likert-scale from 1 to 4, respectively. A mean item-score for the complete scale will be calculated (range: 1.0-4.0).

    As one of the main aims of REFUGE-I is to compare the prevalence of common mental health problems in resettled Syrian refugees in Norway to prevalences found in a parallel study in Sweden, REFUGE-I will use the same Arabic HTQ-version as was used in Sweden (Tinghög et al., 2017)


  2. Hopkins Symptom Checklist (HSCL-25) [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]

    The HSCL-25 scale consists of 25 items and measures symptoms of anxiety and depression (Lavik, Hauff, Solberg, & Laake, 1999; Mollica, Wyshak, de Marneffe, Khuon, & Lavelle, 1987). Part I has 10 items for anxiety symptoms, and Part II has 15 items for depression symptoms. All items have four categorical responses: Not at all; A little; Quite a bit; and Extremely, scored on a Likert-scale from 1 to 4, respectively. Three mean scores are calculated: mean score for all 25 items; mean score for anxiety (average of the 10 anxiety items), and mean score for depression (average of the 15 depression items).

    As one of the main aims of REFUGE-I is to compare the prevalence of common mental health problems in resettled Syrian refugees in Norway to prevalences found in a parallel study in Sweden, REFUGE-I will use the same Arabic HSCL-version as was used in Sweden (Tinghög et al., 2017).


  3. The World Health Organization Quality of Life assessment (WHOQOL-BREF) [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    WHOQOL-BREF is an abbreviated generic quality of life (QoL) scale developed through the World Health Organization (The WHOQOL Group, 1998). The scale contains 26 items. The first two items are stand-alone items aimed at measuring quality of life in general (item 1) and quality of life related to health (item 2). The other 24 items measure four different domains of quality of life: Physical health (7 items); Psychological health (6 items); Social relationships (3 items); and Environment (8 items). All items are scored on a 5-point Likert scale going from 1 (poor QoL) to 5 (high QoL). A tested and validated Arabic version of WHOQOL-BREF will be used (Ohaeri & Awadalla, 2009).


Secondary Outcome Measures :
  1. Post-migration stress scale [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    Data on post-migration stress will be collected through the Post-migration stress scale developed by Malm et al (Malm, Tinghög, & Saboonchi, 2016). The complete scale consists of 24 items, all scored on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). Analyses will focus on seven questions thought to tap into the seven different domains of the Post-migration stress scale (for details, please see (Tinghög et al., 2017). The scale was translated into Arabic by the original research group (Malm et al., 2016)

  2. Somatic pain: Likert scale [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    The questions on pain are based on The Tromsø Study, but slightly adapted to the study population of REFUGE-I (Andorsen, Ahmed, Emaus, & Klouman, 2016; "The Tromsø Study," n.d.). Participants will be asked about pain in muscles and joints in the last year, lasting for a minimum of 3 months, scored on a 3-point Likert scale (Not troubled; Somewhat troubled; and Very troubled) in the following 5 areas: Neck and shoulders; Arms or hands; Upper back, Lower back; and Hips, legs or feet. Similarly, using the same 3-point scale, participants will be asked about general pain in the following 5 areas: Stomach; Head; Genital area; Chest; and Other. The translation of the questions into Arabic was done by a professional translation bureau, then checked by two independent translators/interpreters. In addition, a thorough review was conducted by an Arabic speaking reference group from Syria.

  3. Sleep difficulties [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    The Bergen Insomnia Scale will be used to investigate sleep difficulties (Pallesen et al., 2008). The six-item scale focuses on: problems falling asleep; extended awakenings during the night; early awakenings; feeling tired/fatigued/not rested after sleep; and overall dissatisfaction with sleep quality. All items are answered on a 8-point Likert scale going from 0 (No days in the week) to 7 (Every day during the week). A mean-item score will be calculated for the six questions combined (range: 0-7). The translation of the questions into Arabic was done by a professional translation bureau, then checked by two independent translators/interpreters. In addition, a thorough review was conducted by an Arabic speaking reference group from Syria.

  4. Perceived general health [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    Two questions will used to measure perceived general health. Both questions are from the European Social Survey. Question one on overall health, "How is your health in general", has six answer categories: Very good; Good; Fair; Bad; Very bad; and Don't know. Question two, "Are you hampered in your daily activities in any way by any longstanding illness, or disability, infirmity or mental health problem?", taps into functional impairment and has four answer categories: No; Yes to some extent; Yes a lot; Don't know. The translation of the questions into Arabic was done by a professional translation bureau, then checked by two independent translators/interpreters. In addition, a thorough review was conducted by an Arabic speaking reference group from Syria.


Other Outcome Measures:
  1. Refugee Trauma History Checklist (RTHC) [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    Data on potentially traumatic events experienced by study participants either before (premigration) or during (perimigration) their flight from their home will be collected using the Refugee Trauma History Checklist (RTHC) developed by Sigvardsdotter and colleagues (Sigvardsdotter et al., 2017). The checklist asks whether respondents have experienced eight potentially traumatic events either before or during their flight (separate scales for "before" vs "during"). In total, therefore, there are 16 items in the scale - 8 concerning premigration events and 8 concerning perimigration events, all answered on a binary outcome scale (Yes/No). The scale was translated into Arabic by the original research group (Sigvardsdotter et al., 2017).

  2. Enhancing Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI) [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    Data on social support will be collected using the first 6 items of the ENRICHD Social Support Inventory, ESSI (Mitchell et al., 2003). All 6 items are scored on a 5-point Likert scale going from 1 (None of the time) to 5 (All the time). The translation of the questions into Arabic was done by a professional translation bureau, then checked by two independent translators/interpreters. In addition, a thorough review was conducted by an Arabic speaking reference group from Syria.

  3. Number of intrusive memories: [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]
    Intrusive memories (IMs) is described as: "relatively brief, vivid sensory impressions such as images, sounds, body sensations, tastes, or smells related to an event. They may or may not be triggered by something you are aware of, such as telling someone about what has happened to you or watching something on the news. Intrusive memories are not the same as deliberately thinking about a traumatic event or mulling it over". The definition is based on the DSM-V diagnostic manual and earlier research on Syrian refugees (Association & Others, 2013; Holmes et al., 2017). Participants will be asked if they experience IMs (Y/N), and if Yes, they will be asked how often they experience them (Less than monthly; Monthly; Weekly; Daily or almost daily; Several times each day; and how distressing they feel the IMs are on a scale from 0 to 10. The questions were translated following the same procedures as described under ESSI above.

  4. Alcohol consumption [ Time Frame: Collected as part of the survey questionnaire sent out to the sample of participants. Participants will have 6 weeks to answer and return the survey. Anticipated time frame for collection: November 27, 2018 to January 15, 2019. ]

    Participants will be asked the following four questions on alcohol (answer choices in parentheses):

    1. Whether they drink (Y/N).
    2. If yes, how often they drink (Never; Monthly or less; 2 to 4 times a month; 2 to 3 times a week; and 4 or more times a week).
    3. How many drinks containing alcohol they drink on a typical day when they drink (0; 1-2; 3-4; 5-6; 7-9; and 10 or more).
    4. How often they drink six or more drinks on one occasion (Never; Less than monthly; Monthly; Weekly; and Daily or almost daily).

    The translation of the questions into Arabic was done by a professional translation bureau, then checked by two independent translators/interpreters. In addition, a thorough review was conducted by an Arabic speaking reference group from Syria.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population comprises a random sample of 10 000 out of a total of 14350 resettled Syrians coming to Norway between January 1, 2015 and December 31, 2017 as: resettlement refugees (quota refugees), asylum seekers (approved asylum), or through family immigration (see Inclusion criteria). The sample was selected through simple random sampling (sampling fraction 0.7).
Criteria

Inclusion Criteria:

  • Syrian citizen who arrived to Norway as either resettlement refugee (quota refugee) or asylum seeker and asylum was granted/approved; or who arrived through the program: "Family immigration with a person who has protection (asylum) in Norway"
  • Arrived to Norway between January 1, 2015 and December 31, 2017.
  • Registered with a postal address in the Norwegian National Registry

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742128


Locations
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Norway
Norwegian Center for Violence and Traumatic Stress Studies
Oslo, Norway
Sponsors and Collaborators
Norwegian Center for Violence and Traumatic Stress Studies
Norwegian Institute of Public Health
Inland Norway University of Applied Sciences
Swedish Red Cross University College
Karolinska Institutet
Investigators
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Principal Investigator: Arnfinn Andersen, Dr. Polit. Norwegian Center for Violence and Traumatic Stress Studies

Publications:
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.
BBC News. (2018, September 7). Why is there a war in Syria? BBC. Retrieved from https://www.bbc.com/news/world-middle-east-35806229
American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.). Washington, DC: Author.
Lavik, N. J., Hauff, E., Solberg, Ø., & Laake, P. (1999). The use of self-reports in psychiatric studies of traumatized refugees: Validation and analysis of HSCL-25. Nordic Journal of Psychiatry, 53(1), 17-20. https://doi.org/10.1080/080394899426666
Malm, A., Tinghög, P., & Saboonchi, F. (2016). Post-migration stress among refugees - development of a new scale and associations with wellbeing. European Health Psychologist, 18(S), 651. Retrieved from http://www.ehps.net/ehp/index.php/contents/article/view/2004
Statistics Norway (SSB). (n.d.). Retrieved October 5, 2018, from https://www.ssb.no/en
United Nations High Commissioner for Refugees. (2018). Syria emergency. Retrieved October 5, 2018, from http://www.unhcr.org/syria-emergency.html
World Health Organization. Division of Mental Health. (1996). WHOQOL-BREF : introduction, administration, scoring and generic version of the assessment : field trial version, December 1996. Geneva : World Health Organization. http://www.who.int/iris/handle/10665/63529

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Responsible Party: Norwegian Center for Violence and Traumatic Stress Studies
ClinicalTrials.gov Identifier: NCT03742128     History of Changes
Other Study ID Numbers: NKVTS 2017/1252
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study's data sharing strategy has not yet been developed.
Time Frame: To be decided
Access Criteria: To be decided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress, Psychological
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms