The REFUGE-study: Health and Quality of Life Among Resettled Syrian Refugees and Asylum-seekers in Norway (REFUGE-I)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Hopkins Symptom Checklist (HSCL-25)
研究概览
简要总结
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.
详细描述
Participants:
A complete list of potential participants meeting Inclusion criteria (see relevant section in the submitted registration) was obtained in collaboration with the Norwegian National Registry administered by the Norwegian Tax Administration. The complete list consisted of 14350 individuals which constituted the study's sampling frame. A simple random probability sample of 10 000 individuals was selected from the sampling frame (sampling fraction = 0.7). The actual sampling was conducted without any involvement from members of the REFUGE-I research team.
Data collection:
All sampled participants will be sent a postal package to their registered residential address in Norway. The package will contain a prepaid return envelope, the survey questionnaire and a cover letter in Arabic describing the purpose of the study, its voluntary nature, what potential participants can expect if they do participate, and how issues surrounding confidentiality and anonymity will be handled. The cover letter also highlights that survey data will be linked to registry data as part of the longitudinal study. Potential participants will be enabled to give written informed consent to participation at the bottom of the cover letter and instructed to enclose the written consent with the completed survey questionnaire in the prepaid return envelope. Data from participants returning the questionnaire without also submitting written consent to participation will be deleted in accordance with agreements made with the Regional Committees for Medical and Health Research Ethics (REC) - Region South East which granted the ethical approval for the study.
The survey questionnaire is eight pages long and expected to take about an hour to complete. All instructions and questions in the questionnaire are in Arabic. Standard and pre-existing scales in Arabic were used whenever available and Arabic translations were done by professional translators in collaboration with an Arabic speaking reference group for scales/items that did not already exist in Arabic. Potential participants will have about 8 weeks to complete and return the questionnaire with written consent. One postal reminder, together with a blank copy of the survey questionnaire and a prepaid return envelope will be sent out to participants who have not returned the questionnaire by a preset deadline - about two weeks before the anticipated closing date for data collection (approximately January 15, 2019). This is in accordance with Norwegian rules and regulations governing research with voluntary subjects which prohibits more than one reminder being sent out.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •Registered with a postal address in the Norwegian National Registry
排除标准
- 未提供
结局指标
主要结局
Hopkins Symptom Checklist (HSCL-25)
时间窗: 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).
Harvard Trauma Questionnaire (HTQ)
时间窗: 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)
The World Health Organization Quality of Life assessment (WHOQOL-BREF)
时间窗: 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).
次要结局
- 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.)
- 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.)
- 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.)
