Migration-related determinants of health-care service utilization among persons with a direct migration background in Germany: an exploratory study based on the German Socio-Economic Panel (SOEP).

BACKGROUND: It is known that the health-care service utilization in primary care of persons with a direct migration background is lower compared to non-migrants. However, potential migration-related determinants of health-care service utilization are not known. Therefore, this study aimed to analyze the associations between health-care service utilization and migration-related characteristics of persons with a direct migration background in Germany. METHODS: The migration samples (M1 and M2) of the German Socio-Economic Panel (SOEP) were used as the sample for this study. Associations between the number of visits to primary care physicians in the previous three months and migration-related characteristics were examined using generalized linear models. Associations between the hospitalization within one year and migration-related characteristics were examined using logit models. RESULTS: The mean number of visits to primary care physicians was about 2, and 8% of persons were hospitalized. Being born in a country other than Russia was associated with a higher number of visits to primary care physicians (+ 26% to + 34%). Both, a very strong connectedness with the country of birth and very good oral German language skills were associated with higher number of visits to primary care physicians (both + 13%) compared to no connectedness and fairly bad oral German language skills. CONCLUSION: Only the country of birth, connectedness with the country of birth and oral German language skills may be migration-related determinants of health-care service utilization with regard to the number of visits to primary care physicians by persons with a direct migration background in Germany. With regard to hospitalization, no potential migration-related determinants of health-care service utilization could be identified.

Flight-related determinants of health-related quality of life of asylum seekers and refugees in Germany: a longitudinal study based on the German Socio-Economic Panel (SOEP).

BACKGROUND: Germany played a key role as receiving country during the so-called refugee and displacement crisis with about 5 million asylum seekers arriving in the EU between 2014 and 2020. It is well known that asylum seekers and refugees (ASRs) have a high burden of disease and are particularly prone to mental disorders such as trauma, stress-related and affective disorders. Not much is known about the determinants of health-related quality of life (HrQoL) among ASRs, especially in the context of the flight. Therefore, the aim of this study was to analyze the associations between flight-related characteristics and HrQoL of ASRs in Germany. METHODS: The sample of this study was based on five consecutive waves of the Survey of Refugees samples of the German Socio-Economic Panel (n = 8015; 14,314 observations). Mental and physical HrQoL was measured using the mental (MCS) and physical (PCS) component summary scores of the SF-12v2. Associations between flight-related characteristics and HrQoL were examined using multilevel mixed-effects linear regressions. RESULTS: The different countries of birth were associated with varying MCS and PCS scores. The MCS and PCS scores were lower among ASRs with an economic situation below average in their countries of origin. Persecution, discrimination, and poor living conditions as reasons for leaving the county were associated with lower MCS scores. ASRs who were dissatisfied with their own living situation and who were discriminated often due to their origin had both lower MCS and PCS scores. Not feeling welcome in Germany and missing people from one's country of origin were both associated with lower MCS scores. No worries about not being able to stay in Germany or not being able to return to one's country of origin were both associated with higher MCS scores. CONCLUSIONS: The economic situation in the country of origin and the presence of persecution, discrimination, and/or poor living conditions as reason for flight may be pre-flight-related determinants of HrQoL of ASRs in Germany. Possible post-flight-related determinants can be the residence status, the satisfaction with one's living situation, discrimination due to one's origin and a feeling of missing people from one's country of origin. With regard to those determinants, the clarity about the residence status, reducing racial discrimination and the mourning of flight-related circumstances must be ensured.

Migration-related determinants of health-related quality of life of persons with direct migration background in Germany: a study based on the German Socio-Economic Panel.

Introduction: Persons with a direct migration background made up a share of around 17% of the total German population in the year 2020. Not much is known about migration-related determinants of health-related quality of life (HrQoL) of persons with direct migration background. This study aimed to analyze the associations between HrQoL, sociodemographic, and migration-related characteristics of persons with direct migration background in Germany. Methods: The sample of this study was based on four waves (2014, 2016, 2018, and 2020) of the migration samples (M1 and M2) of the German Socio-Economic Panel (SOEP). The SF-12 was used to measure HrQoL using its mental (MCS) and physical (PCS) component summary scores. Missing information was replaced by multiple imputation by chained equations with predictive mean matching. Associations between HrQoL and sociodemographic and migration-related characteristics were examined using multilevel mixed-effects linear regressions. Results: The mean MCS and PCS scores of persons with direct migration background(n = 4,124) were 51.81 and 51.57, respectively. Being born in Russia was associated statistically significantly with a lower PCS score compared with non-east European and American/Oceanic countries. A longer period since migration to Germany was negatively associated with both MCS and PCS scores (both with p < 0.01). A steady relationship before migration was associated with a higher MCS score (+0.69, p = 0.017). Not feeling German and experiencing disadvantages due to origin were negatively associated with the MCS (both with p < 0.001). The oral ability in the German language was positively associated with the PCS score (p < 0.05). Conclusion: The time since migration to Germany, and the relationship status before migration may be determinants of HrQoL of persons with a direct migration background. Furthermore, connectedness with Germany, disadvantages due to origin and oral ability in the German language, representative of integration in Germany, can be potential determinants of HrQoL. Thus, integration of persons with migration background is crucial for their mental and physical HrQoL.

Health-Related Quality of Life as Assessed by the EQ-5D-5L Predicts Outcomes of Patients Treated with Azacitidine-A Prospective Cohort Study by the AGMT.

In this prospective study (NCT01595295), 272 patients treated with azacitidine completed 1456 EuroQol 5-Dimension (EQ-5D) questionnaires. Linear mixed-effect modelling was used to incorporate longitudinal data. When compared with a matched reference population, myeloid patients reported more pronounced restrictions in usual activities (+28%, p < 0.0001), anxiety/depression (+21%, p < 0.0001), selfcare (+18%, p < 0.0001) and mobility (+15%, p < 0.0001), as well as lower mean EQ-5D-5L indices (0.81 vs. 0.88, p < 0.0001), and lower self-rated health on the EuroQol Visual Analogue Scale (EQ-VAS) (64 vs. 72%, p < 0.0001). After multivariate-adjustment, (i) the EQ-5D-5L index assessed at azacitidine start the predicted time with clinical benefit (TCB) (9.6 vs. 6.6 months; p = 0.0258; HR = 1.43), time to next treatment (TTNT) (12.8 vs. 9.8 months; p = 0.0332; HR = 1.42) and overall survival (OS) (17.9 vs. 12.9 months; p = 0.0143; HR = 1.52); (ii) Level Sum Score (LSS) predicted azacitidine response (p = 0.0160; OR = 0.451) and the EQ-5D-5L index showed a trend (p = 0.0627; OR = 0.522); (iii) up to 1432 longitudinally assessed EQ-5D-5L response/clinical parameter pairs revealed significant associations of EQ-5D-5L response parameters with haemoglobin level, transfusion dependence and hematologic improvement. Significant increases of the likelihood ratios were observed after addition of LSS, EQ-VAS or EQ-5D-5L-index to the International Prognostic Scoring System (IPSS) or the revised IPSS (R-IPSS), indicating that they provide added value to these scores.

Psychometric evaluation of the German version of the Recovering Quality of Life (ReQoL) measures in patients with affective disorders.

BACKGROUND: The generic self-reported Recovering Quality of Life (ReQoL) measures were developed for measuring recovery-focused health-related quality of life (HrQoL) in persons with mental health conditions. The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with affective disorders in Germany. METHODS: Data from a patient sub-sample in a randomized controlled trial have been used (N = 393). The internal consistency and the test-retest reliability of the ReQoL measures were assessed using Cronbach's Alpha and the intra-class correlation coefficient (ICC). The concurrent validity and the known-group validity of the ReQoL measures were assessed using Pearson's Correlation coefficient and Cohen's d. The responsiveness was assessed using Glass' Δ and the standardized response mean (SRM). RESULTS: The reliability among the items of the ReQoL-20 was overall excellent. The ICC of the ReQoL-20 was r = 0.70, indicating moderate test-retest reliability. The concurrent validity of the ReQoL-20 with the clinical measure PHQ-9 was strong with a correlation coefficient of r = - 0.76. The known-group validity of the ReQoL-20 using PHQ-9 cut-off points was large with an effect size of d = 1.63. The ReQoL measures were sensitive to treatment response and remission of symptoms measured by the PHQ-9 with large effect sizes/SRM. DISCUSSION: The psychometric properties of the ReQoL measures for the assessment of patients with affective disorders were overall good. With the ReQoL, valid and reliable measures for the assessment of recovery-focused HrQoL for persons with affective disorders are available in German language.

Validation of the Recovering Quality of Life (ReQoL) questionnaires for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders in Germany.

The health-related quality of life (HrQoL) and the recovery process of persons with mental health conditions can be assessed with the Recovering Quality of Life questionnaires (ReQoL-20 and ReQoL-10). The aim of this study was to assess the psychometric properties of the German version of the ReQoL measures in patients with anxiety, obsessive-compulsive, stress-related, and somatoform disorders and in patients with disorders of adult personality and behavior. This study was based on a sub-sample of patients that were included in a randomized controlled trial evaluating an evidence-based, stepped and coordinated care service model for mental disorders (RECOVER). The internal consistency was assessed using Cronbach's Alpha and the test-retest reliability was assessed by the intra-class correlation coefficient (ICC). Concurrent validity was assessed by Pearson's Correlation Coefficient and the known-group validity was assessed using the Cohen's d. The internal consistency of the ReQoL-20 and ReQoL-10 was excellent and good with Cronbach's alpha of α = 0.91 and α = 0.83 for all items. The test-retest reliability of the ReQoL measures was moderate with ICC of r = 0.72 to 0.74. The concurrent validity of the ReQoL measures with the Global Severity Index was overall high with a correlation coefficient of r = -0.70. In conclusion, for patients with anxiety, obsessive-compulsive, stress-related, somatoform and personality disorders, the German version of the ReQoL measures is valid and reliable for the assessment of HrQoL and the recovery process.

Interdisciplinary, internet-based trans health care (i²TransHealth): study protocol for a randomised controlled trial.

INTRODUCTION: Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants' place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers' perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network? METHODS AND ANALYSIS: In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth. ETHICS AND DISSEMINATION: Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications. TRIAL REGISTRATION NUMBER: NCT04290286. PROTOCOL VERSION: 22 December 2021 (V.1.0).

[Occupational Participation of Syrian Refugees with Posttraumatic Stress in Germany]. / Berufliche Teilhabe von syrischen Geflüchteten mit posttraumatischer Stress-Symptomatik in Deutschland.

OBJECTIVE: Description of employment situation and search for determinants of employment depending on symptom severity in refugees with posttraumatic stress. METHODS: Standardized interviews with 133 Syrian refugees (18 to 65 years) living in Germany with posttraumatic stress symptoms and exploratory data analysis. RESULTS: 27.1 % of the participants were employed; including 13.9 % women and 86.1 % men (p = 0.001). Links between mental health and employment can be shown (posttraumatic stress p = 0.039, depressiveness p = 0.020, somatisation p = 0.026). With regard to social support and type of trauma, as well as residence status and duration of residence, there were no differences between refugees with and without employment. CONCLUSION: The current analysis on the employment situation of a circumscribed group of Syrian refugees focuses on the importance of psychological symptom burden.

Health-related quality of life of individuals sharing a household with persons with dementia.

INTRODUCTION: Previous research has found a negative effect of dementia on the health-related quality of life (HrQoL) of persons with dementia (PWD) and their primary informal caregivers. However, the impact of dementia on HrQoL of other individuals sharing a household with PWD has not been investigated to date. The current study therefore aimed to determine differences in the HrQoL between those sharing a household with PWD and those not living with PWD. In addition, factors related to the HrQoL of those sharing a household with PWD were evaluated. METHODS: The analyses were based on data from the German Socio-Economic Panel, using the SF-12 to measure HrQoL. Mixed-effects models were calculated to compare the HrQoL of those sharing a household with PWD and persons not living with PWD, as well as to determine factors related to the HrQoL of those sharing a household with PWD. Bootstrapping was used where residuals were not normally distributed. RESULTS: Mixed-effect models showed a significantly lower HrQoL among those sharing a household with PWD, compared to those not living with PWD. Number of diseases, number of persons in the household, marital status and educational level were significantly related to HrQoL among those sharing a household with PWD. DISCUSSION: The HrQoL of those sharing a household with PWD was reduced compared to persons not living with PWD. Further, those living with PWD in small households, or those with multi-morbidities had a lower HrQoL. Further research focusing on HrQoL in the social environment of PWD is needed.

Health Care Services Utilization of Persons with Direct, Indirect and without Migration Background in Germany: A Longitudinal Study Based on the German Socio-Economic Panel (SOEP).

There is ambiguous evidence with regard to the inequalities in health care services utilization (HCSU) among migrants and non-migrants in Germany. The aim of this study was to analyze the utilization of doctors and hospitalization of persons with direct and indirect migration background as well as those without in Germany. This study was based on data of the German Socio-Economic Panel using the adult sample of the years 2013 to 2019. HCSU was measured by self-reported utilization of doctors and hospitalization. Associations between HCSU and migration background were examined using multilevel mixed-effects logistic regression and zero-truncated multilevel mixed-effects generalized linear models. The odds ratios of utilization of doctors and hospitalization for persons with direct migration background compared with persons without migration background were 0.73 (p < 0.001) and 0.79 (p = 0.002), respectively. A direct migration background was associated with a 6% lower number of doctoral visits within three months compared with no migration background (p = 0.023). Persons with direct migration background still have a lower HCSU than persons without migration background in Germany. Access to health care needs to be ensured and health policy-makers are called upon to keep focus on the issue of inequalities in HCSU between migrants and non-migrants in Germany.

Predictors of psychological distress in Syrian refugees with posttraumatic stress in Germany.

Syria has been the main country of citizenship of refugees in Germany since 2013. Syrians face numerous human rights violations in their country that can be accompanied by the experience of potentially traumatic events, loss and displacement. Along the migration process, refugees are exposed to various factors that can have an impact on mental health. The aim of this study is to investigate sociodemographic, war- and flight-related as well as post-migration factors as predictors of posttraumatic stress, depression, somatization and anxiety in Syrian refugees with posttraumatic stress symptoms based in Germany. Data were based on the baseline sample of the "Sanadak" randomized-controlled trial. A total of 133 adult Syrian refugees participated in the study. A questionnaire covered sociodemographic and flight-related questions as well as standardized instruments for symptoms of PTSD (PDS-5), depression (PHQ-9), somatization (PHQ-15), anxiety (GAD-7), generalized self-efficacy (GSE), religiousness (Z-Scale), social support (ESSI) and mental health stigma (SSMIS-SF). Linear regression models were executed to predict mental health outcomes. Sociodemographic predictors (i.e., female sex, higher education) and flight-related predicting factors (i.e., variability of traumatic events) have a negative impact on mental health in Syrian refugees with posttraumatic stress symptoms in Germany. Mental health stigma predicts worse mental health outcomes. Post-migration factors have a major impact on mental health, such as low income, lack of social support, low life satisfaction or a strongly felt connection to Syria. Somatization is an important manifestation of mental distress in Syrian refugees with posttraumatic stress symptoms. Our study showed a range of factors predicting the mental health of Syrian refugees with posttraumatic stress symptoms. Measures to foster mental health could be securing financial security, promoting gender equality and tailored psychosocial programs addressing mental health stigma, loss and social support networks.

Mental Health Self-Stigma of Syrian Refugees With Posttraumatic Stress Symptoms: Investigating Sociodemographic and Psychopathological Correlates.

Background: The high prevalence of mental disorders related to posttraumatic stress among Syrian refugees is often in contrast with their low utilization of mental health care in the host countries. Mental health self-stigma, i.e., internalized stigma of having a mental disorder, could prevent individuals from seeking mental health care. Therefore, we aimed to provide evidence on different aspects of mental health self-stigmatization among adult Syrian refugees with posttraumatic stress symptoms residing in Germany. Moreover, we investigated associations with sociodemographic and psychopathological variables in order to identify those at higher risk of self-stigmatization. Material and Methods: Overall, 133 participants with mild to moderate posttraumatic stress symptoms were recruited in the metropolitan areas of Leipzig, Dresden and Halle, Germany, using a multimodal approach. Mental health self-stigma was assessed using the Self-Stigma of Mental Illness Scale - Short Form (SSMIS-SF), consisting of four subscales (Stereotype awareness, Stereotype agreement, Application to self , Harm to self-esteem), each scoring from 5 (low) to 45 (high) points. Linear regression analysis was used to test associations of sociodemographic and psychopathological variables with self-stigma subscales. Results: On average, self-stigma ratings ranged from 16.5 (SD = 6.6) points on Application to self to 28.3 (SD = 7.5) points on Stereotype awareness. Results showed higher scores on Application to self for individuals who were younger (t = 2.65, p = 0.009) and single (F = 5.70, p = 0.004). Regression analyses yielded statistically significant associations between having multiple comorbidities and a higher Application to self stigma (ß = 0.18, p = 0.044), controlling for sociodemographic covariates. Discussion: Mental health self-stigma was increased among Syrian refugees in Germany. Correlates of increased self-stigma could inform efforts to improve access to mental health care among Syrian refugees with mental ill-health. Longitudinal studies following an intersectional approach by concurrently examining multiple forms of public and internalized stigma could provide helpful insights for developing tailored stigma reduction efforts in this context.

Health Care Services Utilization and Health-Related Quality of Life of Syrian Refugees with Post-Traumatic Stress Symptoms in Germany (the Sanadak Trial).

Refugees who have fled from the ongoing civil war in Syria that arrived in Germany often develop post-traumatic stress symptoms (PTSS). The aim of this study was to determine health care services utilization (HCSU), health care costs and health-related quality of life (HrQoL) of Syrian refugees with mild to moderate PTSS without current treatment in Germany. The study was based on the baseline sample of a randomized controlled trial of a self-help app for Syrian refugees with PTSS (n = 133). HCSU and HrQoL based on the EQ-5D-5L and its visual analogue scale (EQ-VAS) were assessed with standardized interviews. Annual health care costs were calculated using extrapolated four-month HCSU and standardized unit costs. Associations between health care costs, HrQoL and PTSS severity were examined using generalized linear models. Overall, 85.0% of the sample utilized health care services within four months. The mean total annual health care costs were EUR 1920 per person. PTSS severity was not associated with health care costs. The EQ-5D-5L index score and the EQ-VAS score was 0.82 and 73.6, respectively. For Syrian refugees with higher PTSS severity, the EQ-5D-5L index score was lower (-0.17; p < 0.001). The HCSU and the resulting health care costs of Syrian refugees with mild to moderate PTSS without current treatment are low and those with a higher PTSS severity had a lower HrQoL.

Health-Related Quality of Life of Persons with Direct, Indirect and No Migration Background in Germany: A Cross-Sectional Study Based on the German Socio-Economic Panel (SOEP).

Global migration towards and within Europe remains high, shaping the structure of populations. Approximately 24% of the total German population had a migration background in 2017. The aim of the study was to analyze the association between migration background and health-related quality of life (HrQoL) in Germany. The analyses were based on 2014 and 2016 data of the German Socio-Economic Panel. Differences in sociodemographic characteristics between migrant and non-migrant samples were equal by employment of the entropy balancing weights. HrQoL was measured using the physical (PCS) and mental (MCS) component summary scores of the SF-12v2. Associations between PCS and MCS scores and migration background were examined using Student's t-test. The mean PCS and MCS scores of persons with migration background (n = 8533) were 51.5 and 50.9, respectively. Persons with direct migration background had a lower PCS score (-0.55, p < 0.001) and a higher MCS score (+1.08, p < 0.001) than persons without migration background. Persons with direct migration background differed with respect to both physical and mental HrQoL from persons without migration background in the German population. Differences in HrQoL for persons with indirect migration background had p = 0.305 and p = 0.072, respectively. Causalities behind the association between direct migration background and HrQoL are to be determined.

Traumatized Syrian Refugees with Ambiguous Loss: Predictors of Mental Distress.

Refugees from war zones often have missing significant others. A loss without confirmation is described as an ambiguous loss. This physical absence with simultaneous mental persistence can be accompanied by economic, social or legal problems, boundary ambiguity (i.e., uncertainty about who belongs to the family system), and can have a negative impact on mental health. The aim of this study was to identify sociodemographic and loss-related predictors for prolonged grief, anxiety, depression, post-traumatic stress disorder (PTSD) and somatization in treatment-seeking Syrian refugees with post-traumatic stress symptoms in Germany experiencing ambiguous loss. For the present study, data were based on the treatment-seeking baseline sample of the "Sanadak" randomized-controlled trial, analyzing a subsample of 47 Syrian refugees with post-traumatic stress symptoms in Germany experiencing ambiguous loss. Sociodemographic and loss-related questions were applied, along with standardized instruments for symptoms of prolonged grief (ICG), anxiety (GAD-7), depression (PHQ-9), PTSD (PDS-5) and somatization (PHQ-15). Linear regression models were used to predict mental health outcomes. Having lost a close family member and higher boundary ambiguity showed a statistically significant association with higher severity in prolonged grief. The overall model for somatization reached statistical significance, while no predictor independently did. Boundary ambiguity showed a statistically significant positive association with depression, while the overall model showed no statistically significant associations. Boundary ambiguity and missing family members seemed to be important predictors for prolonged grief. These findings support the importance of reunification programs and suggest an inclusion of the topic into psychosocial support structures, e.g., including psychoeducational elements on boundary ambiguity in support groups for traumatized individuals and families experiencing ambiguous loss. Further research is needed for a more detailed understanding of the impact of ambiguous loss on refugee populations.

Using a brief web-based 5A intervention to improve weight management in primary care: results of a cluster-randomized controlled trial.

BACKGROUND: The primary health care setting is considered a major starting point in successful obesity management. However, research indicates insufficient quality of weight counseling in primary care. Aim of the present study was to implement and evaluate a 5A online tutorial aimed at improving weight management and provider-patient-interaction in primary health care. The online tutorial is a stand-alone low-threshold minimal e-health intervention for general practitioners based on the 5As guidance for obesity management by the Canadian Obesity Network. METHODS: In a cluster-randomized controlled trial, 50 primary care practices included 160 patients aged 18 to 60 years with obesity (BMI ≥ 30). The intervention practices had continuous access to the 5A online tutorial for the general practitioner. Patients of control practices were treated as usual. Primary outcome was the patients' perspective of the doctor-patient-interaction regarding obesity management, assessed with the Patient Assessment of Chronic Illness Care before and after (6/12 months) the training. Treatment effects over time (intention-to-treat) were evaluated using mixed-effects linear regression models. RESULTS: More than half of the physicians (57%) wished for more training offers on obesity counseling. The 5A online tutorial was completed by 76% of the physicians in the intervention practices. Results of the mixed-effects regression analysis showed no treatment effect at 6 months and 12 months' follow-up for the PACIC 5A sum score. Patients with obesity in the intervention group scored lower on self-stigma and readiness for weight management compared to participants in the control group at 6 months' follow-up. However, there were no significant group differences for weight, quality of life, readiness to engage in weight management, self-stigma and depression at 12 months' follow-up. CONCLUSION: To our knowledge, the present study provides the first long-term results for a 5A-based intervention in the context of the German primary care setting. The results suggest that a stand-alone low-threshold minimal e-health intervention for general practitioners does not improve weight management in the long term. To improve weight management in primary care, more comprehensive strategies are needed. However, due to recruitment difficulties the final sample was smaller than intended. This may have contributed to the null results. TRIAL REGISTRATION: The study has been registered at the German Clinical Trials Register (Identifier: DRKS00009241 , Registered 3 February 2016).

Correction: A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial.

[This corrects the article DOI: 10.2196/24807.].

A Self-Help App for Syrian Refugees With Posttraumatic Stress (Sanadak): Randomized Controlled Trial.

BACKGROUND: Syrian refugees residing in Germany often develop posttraumatic stress as a result of the Syrian civil war, their escape, and postmigration stressors. At the same time, there is a lack of adequate treatment options. The smartphone-based app Sanadak was developed to provide cognitive behavioral therapy-based self-help in the Arabic language for Syrian refugees with posttraumatic stress. OBJECTIVE: The aim of this study was to evaluate the effectiveness and cost-effectiveness of the app. METHODS: In a randomized controlled trial, eligible individuals were randomly allocated to the intervention group (IG; app use) or control group (CG; psychoeducational reading material). Data were collected during structured face-to-face interviews at 3 assessments (preintervention/baseline, postintervention/after 4 weeks, follow-up/after 4 months). Using adjusted mixed-effects linear regression models, changes in posttraumatic stress and secondary outcomes were investigated as intention-to-treat (ITT) and per-protocol (PP) analysis. Cost-effectiveness was evaluated based on adjusted mean total costs, quality-adjusted life years (QALYs), and cost-effectiveness acceptability curves using the net benefit approach. RESULTS: Of 170 screened individuals (aged 18 to 65 years), 133 were eligible and randomized to the IG (n=65) and CG (n=68). Although there was a pre-post reduction in posttraumatic stress, ITT showed no significant differences between the IG and CG after 4 weeks (Posttraumatic Diagnostic Scale for DSM-5, Diff -0.90, 95% CI -0.24 to 0.47; P=.52) and after 4 months (Diff -0.39, 95% CI -3.24 to 2.46; P=.79). The same was true for PP. Regarding secondary outcomes, ITT indicated a treatment effect for self-stigma: after 4 weeks (Self-Stigma of Mental Illness Scale/SSMIS-stereotype agreement: d=0.86, 95% CI 0.46 to 1.25; stereotype application: d=0.60, 95% CI 0.22 to 0.99) and after 4 months (d=0.52, 95% CI 0.12 to 0.92; d=0.50, 95% CI 0.10 to 0.90), the IG showed significantly lower values in self-stigma than the CG. ITT showed no significant group differences in total costs and QALYs. The probability of cost-effectiveness was 81% for a willingness-to-pay of €0 per additional QALY but decreased with increasing willingness-to-pay. CONCLUSIONS: Sanadak was not more effective in reducing mild to moderate posttraumatic stress in Syrian refugees than the control condition nor was it likely to be cost-effective. Therefore, Sanadak is not suitable as a standalone treatment. However, as the app usability was very good, no harms detected, and stigma significantly reduced, Sanadak has potential as a bridging aid within a stepped and collaborative care approach. TRIAL REGISTRATION: German Clinical Trials Register DRKS00013782; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013782. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-019-2110-y.

[Recovering Quality of Life: German Translation of a Questionnaire to assess the Quality of Life of People with Mental Disorders]. / Recovering Quality of Life: Deutsche Übersetzung eines Fragebogens zur Erfassung der gesundheitsbezogenen Lebensqualität von Menschen mit psychischen Erkrankungen.

AIM OF THE STUDY: The aim of this study was to translate the self-reported questionnaire "Recovering Quality of Life (ReQoL)" to measure the health-related quality of life of people with mental disorders into German. METHODS: The questionnaire was translated into German independently by 2 qualified translators. Discrepancies in meaning and terminology were checked by reviewing a back translation against the original English version. The German translation of the questionnaire was pretested in 5 patients with mental disorders. RESULTS: The translation of several English phrasings of the questionnaire into German was difficult, mainly due to lingual and cultural differences. By expert discussion of the translation and the pretest in patients with mental disorders, appropriate phrasings were found. CONCLUSION: A German version of the self-reported ReQoL questionnaire is available to measure the health-related quality of life of people with mental disorders.

Recruitment and Baseline Characteristics of Participants in the "Sanadak" Trial: A Self-Help App for Syrian Refugees with Post-traumatic Stress.

Many Syrian refugees residing in Germany have been exposed to traumatizing events, while treatment options are scarce. Therefore, the self-help app "Sanadak" was developed to target post-traumatic stress in Syrian refugees. We aimed to inspect the recruitment and baseline characteristics of the participants in the trial, which is conducted to evaluate the app. Analyses were based on the recruitment sample (n = 170) and the trial sample (n = 133). Data were collected during structured face-to-face interviews in the Arabic language. Targeted outcomes included post-traumatic stress (primary; Post-traumatic Diagnostic Scale for DSM-5/PDS-5) and depressive symptoms, anxiety, resilience, among others (secondary). Recruited individuals were M = 32.8 (SD = 11.2, range = 18-65) years old; 38.8% were women. The average PDS-5 score was 23.6 (SD = 13.2) regarding trauma exposure, which was most frequently related to experiencing military- or combat-related events (32.9%). Moreover, 46.5% had major depression and 51.8% showed low resilience. Anxiety was present in 40.6% of the trial participants. Psychological distress was high in Syrian refugees residing in Germany, enrolled in a trial targeting post-traumatic stress. This underlines the need for intervention. Our results provide important figures on the mental health of a not well-studied population group in Germany.