NCT03742128

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

November 30, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

November 12, 2018

Last Update Submit

November 29, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • Harvard Trauma Questionnaire (HTQ)

    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)

    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.

  • Hopkins Symptom Checklist (HSCL-25)

    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).

    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 World Health Organization Quality of Life assessment (WHOQOL-BREF)

    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).

    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.

Secondary Outcomes (4)

  • Post-migration stress scale

    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.

  • Somatic pain: Likert scale

    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.

  • Sleep difficulties

    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.

  • Perceived general health

    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.

Other Outcomes (4)

  • Refugee Trauma History Checklist (RTHC)

    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.

  • Enhancing Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)

    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.

  • Number of intrusive memories:

    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.

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, Norway

Location

Related Publications (21)

  • American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.

    BACKGROUND
  • Aziz IA, Hutchinson CV, Maltby J. Quality of life of Syrian refugees living in camps in the Kurdistan Region of Iraq. PeerJ. 2014 Nov 11;2:e670. doi: 10.7717/peerj.670. eCollection 2014.

    PMID: 25401057BACKGROUND
  • BBC News. (2018, September 7). Why is there a war in Syria? BBC. Retrieved from https://www.bbc.com/news/world-middle-east-35806229

    BACKGROUND
  • Fazel M, Wheeler J, Danesh J. Prevalence of serious mental disorder in 7000 refugees resettled in western countries: a systematic review. Lancet. 2005 Apr 9-15;365(9467):1309-14. doi: 10.1016/S0140-6736(05)61027-6.

    PMID: 15823380BACKGROUND
  • American Psychiatric Association. (1994). Diagnostic and statistical manual of mental disorders (4th ed.). Washington, DC: Author.

    BACKGROUND
  • Holmes EA, Ghaderi A, Eriksson E, Lauri KO, Kukacka OM, Mamish M, James EL, Visser RM. 'I Can't Concentrate': A Feasibility Study with Young Refugees in Sweden on Developing Science-Driven Interventions for Intrusive Memories Related to Trauma. Behav Cogn Psychother. 2017 Mar;45(2):97-109. doi: 10.1017/S135246581600062X.

    PMID: 28229806BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Mitchell PH, Powell L, Blumenthal J, Norten J, Ironson G, Pitula CR, Froelicher ES, Czajkowski S, Youngblood M, Huber M, Berkman LF. A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. J Cardiopulm Rehabil. 2003 Nov-Dec;23(6):398-403. doi: 10.1097/00008483-200311000-00001. No abstract available.

    PMID: 14646785BACKGROUND
  • Mollica RF, Caspi-Yavin Y, Bollini P, Truong T, Tor S, Lavelle J. The Harvard Trauma Questionnaire. Validating a cross-cultural instrument for measuring torture, trauma, and posttraumatic stress disorder in Indochinese refugees. J Nerv Ment Dis. 1992 Feb;180(2):111-6.

    PMID: 1737972BACKGROUND
  • Mollica RF, Wyshak G, de Marneffe D, Khuon F, Lavelle J. Indochinese versions of the Hopkins Symptom Checklist-25: a screening instrument for the psychiatric care of refugees. Am J Psychiatry. 1987 Apr;144(4):497-500. doi: 10.1176/ajp.144.4.497.

    PMID: 3565621BACKGROUND
  • Morina N, Akhtar A, Barth J, Schnyder U. Psychiatric Disorders in Refugees and Internally Displaced Persons After Forced Displacement: A Systematic Review. Front Psychiatry. 2018 Sep 21;9:433. doi: 10.3389/fpsyt.2018.00433. eCollection 2018.

    PMID: 30298022BACKGROUND
  • Shoeb M, Weinstein H, Mollica R. The Harvard trauma questionnaire: adapting a cross-cultural instrument for measuring torture, trauma and posttraumatic stress disorder in Iraqi refugees. Int J Soc Psychiatry. 2007 Sep;53(5):447-63. doi: 10.1177/0020764007078362.

    PMID: 18018666BACKGROUND
  • Sigvardsdotter E, Nilsson H, Malm A, Tinghog P, Gottvall M, Vaez M, Saboonchi F. Development and Preliminary Validation of Refugee Trauma History Checklist (RTHC)-A Brief Checklist for Survey Studies. Int J Environ Res Public Health. 2017 Oct 4;14(10):1175. doi: 10.3390/ijerph14101175.

    PMID: 28976937BACKGROUND
  • Statistics Norway (SSB). (n.d.). Retrieved October 5, 2018, from https://www.ssb.no/en

    BACKGROUND
  • Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

    PMID: 9626712BACKGROUND
  • Tinghog P, Malm A, Arwidson C, Sigvardsdotter E, Lundin A, Saboonchi F. Prevalence of mental ill health, traumas and postmigration stress among refugees from Syria resettled in Sweden after 2011: a population-based survey. BMJ Open. 2017 Dec 29;7(12):e018899. doi: 10.1136/bmjopen-2017-018899.

    PMID: 29289940BACKGROUND
  • United Nations High Commissioner for Refugees. (2018). Syria emergency. Retrieved October 5, 2018, from http://www.unhcr.org/syria-emergency.html

    BACKGROUND
  • 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

    BACKGROUND
  • Nissen A, Hynek KA, Scales D, Hilden PK, Straiton M. Chronic pain, mental health and functional impairment in adult refugees from Syria resettled in Norway: a cross-sectional study. BMC Psychiatry. 2022 Aug 24;22(1):571. doi: 10.1186/s12888-022-04200-x.

  • Nissen A, Cauley P, Saboonchi F, Andersen A, Solberg O. Cohort profile: Resettlement in Uprooted Groups Explored (REFUGE)-a longitudinal study of mental health and integration in adult refugees from Syria resettled in Norway between 2015 and 2017. BMJ Open. 2020 Jul 1;10(7):e036101. doi: 10.1136/bmjopen-2019-036101.

MeSH Terms

Conditions

Stress, PsychologicalStress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Arnfinn Andersen, Dr. Polit.

    Norwegian Center for Violence and Traumatic Stress Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 15, 2018

Study Start

November 27, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

November 30, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

The study's data sharing strategy has not yet been developed.

Time Frame
To be decided
Access Criteria
To be decided

Locations