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.

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).

[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.

HELP@APP: development and evaluation of a self-help app for traumatized Syrian refugees in Germany - a study protocol of a randomized controlled trial.

BACKGROUND: Syrians represent the largest group among refugees in Germany. Many of them were exposed to sequential traumatizing events including war, escape and post-migration stressors, which significantly increase the risk to develop symptoms of posttraumatic stress and other mental disorders. However, there is a lack of adequate treatment options for traumatized refugees in Germany. Moreover, their access to psychosocial care is often restricted due to legal regulation, language barriers, and unclear cost coverage. We therefore aim to develop a low-threshold supportive self-help app for Syrian refugees with posttraumatic stress symptoms. By conducting a randomized controlled trial, we further aim to evaluate the apps' efficacy, usability, acceptance, and economic health benefit/cost-effectiveness. METHODS: We will develop a modular, interactive self-help app in Arabic, which will be grounded on cognitive-behavioral models for the treatment of posttraumatic stress. Subsequently, screened positive (i.e., Syrian refugees, 18-65 years old, mild to moderate posttraumatic stress symptomatology as quantified by the Posttraumatic Stress Diagnostic Scale for DSM-5/PDS-5) participants (ideally up to n = 234) will be randomly allocated to an intervention (IG) and control group (CG), respectively. Participants in the IG will gain access to the self-help app for one month, while participants in the CG will receive psychoeducational reading material in form of a comprehensive brochure on traumatization and posttraumatic stress. Measurements are scheduled before the intervention (T0), directly after the intervention (T1, one month later) and three months after the intervention (T2). Using linear mixed effect models, we will investigate change in posttraumatic symptomatology. We will also test for changes in secondary outcomes such as depression, anxiety, and quality of life. Moreover, we will inspect the usability and user acceptance of the app. To evaluate the app in terms of its economic health benefit, the incremental cost-effectiveness ratio will be calculated. DISCUSSION: We plan to make the app freely available to the general public after evaluation. Thus, the app can help to add-on to routine care, which currently lacks sufficient and appropriate treatment options for Syrian refugees. TRIAL REGISTRATION: German Clinical Trials Register/Deutsches Register Klinischer Studien (DRKS). Registration ID: DRKS00013782 . Registered: 06th of July 2018.

[Strategies to Recruit Refugees for Intervention Studies: Lessons Learned from the "Sanadak" Trial]. / Strategien zur Rekrutierung von Geflüchteten für Interventionsstudien: Erkenntnisse aus dem "Sanadak"-Trial.

OBJECTIVE: Recruitment of so called rare populations, including refugees, for participation in research studies is challenging. We aim to share our lessons learned regarding recruitment strategies used in the "Sanadak" trial, a randomized controlled trial for the evaluation of a self-help app for Syrian refugees with posttraumatic stress. METHODS: We conducted an interim evaluation of our recruitment strategies. A quantitative analysis addressed how potential study participants first learned about "Sanadak" and in which way they made first contact with us. A qualitative part included problem-centered interviews with our Syrian study nurses (n=3) regarding the success of various recruitment strategies and perceived barriers. RESULTS: Data were available for the recruitment of 140 Syrian refugees. Almost half of the sample (44%) was recruited via personal contact, about another third (36%) by means of study promotion (e. g. Facebook ads), and about a fifth (19%) through multipliers. Typical barriers were concerns regarding data protection, anonymity and stigmatization. DISCUSSION: Snowball sampling was an effective recruitment strategy in our trial. This is also the most acknowledged recruitment strategy for rare populations. In addition, other strategies were useful to increase sample variance. The interim evaluation helped to direct efforts towards effective recruitment strategies and to identify and address barriers. CONCLUSION: Multi-strategic recruitment with a focus on snowball sampling, multiple options to make contact with the study team, and having culturally sensitive members in the study team contributed towards successful recruitment in the "Sanadak"-trial.

[Clinical trial of a stepped and collaborative care model for mental illnesses and comorbidities in the Hamburg Network for Health Services Research]. / Erprobung eines integrierten und gestuften Behandlungsmodells für psychische Störungen und Komorbiditäten im Hamburger Netzwerk für Versorgungsforschung.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

Cost-effectiveness Analysis of a Stepped, Collaborative and Coordinated Health Care Network for Patients with Somatoform Disorders (Sofu-Net).

BACKGROUND: Somatoform disorders are highly prevalent mental disorders causing impairment and large economic burden. In order to improve the diagnosis and management of affected patients, a health care network for somatoform disorders (Sofu-Net) was implemented in primary care. AIMS OF THE STUDY: The aim of the study was to determine the cost-effectiveness of a stepped, collaborative and coordinated health care network for somatoform and functional disorders (Sofu-Net) compared with regular primary care physician (PCP) practices in German primary care from a societal perspective. METHODS: This study was part of a 6-month controlled, prospective, non-randomized, observer-blinded cluster cohort trial. Participants were recruited from 33 PCP practices in Hamburg, Germany. The health care network was a collaboration of PCPs, psychotherapists, inpatient clinics and a specialized outpatient clinic. Participants in the control group received usual care. A cost-effectiveness analysis, using treatment response as measure of effectiveness, was performed. Uncertainty in cost-effectiveness was analyzed using cost-effectiveness acceptability curves. RESULTS: In total, n=218 patients (n=119 patients in the intervention group and n=99 patients in the control group) were included in the study. At 6 months, patients within the Sofu-Net group did not differ significantly from the control group with regard to costs (533; standard error 941) and treatment response (--10.3%). For Sofu-Net, the probability of being cost-effective at a willingness-to-pay (WTP) of 10,000 per additional response to treatment was only 31%. DISCUSSION: Sofu-Net is unlikely to be cost-effective. Even for high WTP, the probability of cost-effectiveness was low. The results were robust to variation of costs included in the analysis as well as when only complete cases were included in the analysis. The most important limitations of the study were that randomization could not be established at patient level and at practice level and that the study design did not allow measurement of costs at baseline. CONCLUSION: Patients with severe somatic symptoms did not benefit from the health care network. Sofu-Net might have reduced costs in patients with moderate somatic symptoms. IMPLICATIONS FOR FURTHER RESEARCH: Owing to the limitations and due to a short follow-up of this study, further cost-effectiveness analyses with high methodological quality and a follow-up of at least one year are needed in order to produce results that are more reliable.

Mapping the Beck Depression Inventory to the EQ-5D-3L in Patients with Depressive Disorders.

BACKGROUND: For cost-utility analyses, data on health state utilities, as provided by the EQ-5D-3L, is needed but not always available. This study specified mapping algorithms from the Beck Depression Inventory (BDI) index to the EQ-5D-3L index adjusted for specific socio-demographic variables for patients with depressive disorders. AIMS OF THE STUDY: The objective of this study was to specify mapping algorithms from the BDI index to the preference-based EQ-5D index for patients with depressive disorders, adjusting for specific socio-demographic variables. METHODS: A sample of 1,074 consecutive patients with depressive disorders from a psychotherapeutic outpatient clinic was included in the study. Standardized clinical interviews were applied to establish reliable diagnoses. For the prediction of the EQ-5D-3L index from the BDI index and selected patient socio-demographic characteristics, ordinary least squares regression with robust standard errors was used. Model prediction properties were tested using the root mean squared error and repeated random sub-sampling cross-validation. RESULTS: The BDI index predicted the EQ-5D-3L index with a significant proportion of variance explained. The highest model goodness of fit was estimated for models with the BDI index and age as independent variables. The root mean squared error of the predicted EQ-5D-3L index in the validation samples was 0.23 for all models. DISCUSSION: The mean observed EQ-5D-3L index values and the mean predicted EQ-5D-3L index values seemed not to differ between models. However, a reduction of variability using cross-validation led to those (rather) accurate mean predicted values. One limitation of this study was the restricted generalizability. Moreover, some uncertainty was introduced in model predictive performance by usage of a dependent estimation sample for validation. IMPLICATIONS FOR FURTHER RESEARCH: The specified mapping algorithms from the BDI index to the EQ-5D-3L index for patients with depressive disorders are acceptable as approximation in cost-utility analyses. A further validation in independent samples is necessary to obtain more confidence in their performance.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.