[Screening to Assess Psychosocial Follow-up Needs in Pediatric Oncology (NPO-11) for Self- and Parent-Report]. / Screening zur Einschätzung des psychosozialen Nachsorgebedarfs in der pädiatrischen Onkologie (NPO-11) für Selbst- und Elternbericht.

BACKGROUND: Children diagnosed with cancer are at increased risk for the development of psychosocial problems. Currently, no qualitative and quantitative tests are available to measure their need for psychosocial follow-up care. The NPO-11 screening was developed to tackle this issue. PATIENTS AND METHODS: 11 dichotomous items were generated to measure self- and parent-reported fear of progression, sadness, avolition, self-esteem problems, school and vocational problems, somatic complaints, emotional withdrawal, social disintegration, pseudo-maturity, parent-child conflicts, and parental conflicts. Data from N=101 parent-child dyads were obtained to validate the NPO-11. RESULTS: Self- and parent-reported items showed few missing values and response frequencies without floor or ceiling effects. Inter-rater reliability was fair to moderate. Factor analysis confirmed a single-factor model and therefore an overall NPO-11 sum score. Self- and parent-reported sum scores had sufficient to good reliability and large correlations with health-related quality of life. CONCLUSION: The NPO-11 is a screening for psychosocial needs in pediatric follow-up care with good psychometric properties. It may help to plan diagnostics and interventions for patients transitioning from in-patient to out-patient treatment.

Factors Associated With Treatment Response in an Internet-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement.

Internet-based psychological interventions have proven effective in the treatment of prolonged grief disorder (PGD). Yet, some patients do not benefit from treatment in a clinically significant way. We aimed to examine predictors of symptom reduction in an Internet-based intervention for PGD after cancer bereavement, in order to identify possible treatment mechanisms and discern directions for future intervention design. A secondary analysis of data from a randomized wait-list controlled trial on an Internet-based intervention for PGD after cancer bereavement was conducted. Multiple regression models were used (1) to test for the influence of pretreatment PGD, working alliance, avoidance and gender on PGD symptom reduction; and (2) to explore further predictors of treatment success with a best subset selection protocol. The regression models explained 18% (Model 1) and 34% (Model 2) of variance in symptom reduction. Participants with more favorable symptom change had more severe pretreatment PGD scores and better working alliance. Those with lower social support and less posttraumatic growth experienced more PGD symptom change. In conclusion, therapeutic alliance is an important factor that should be monitored and fostered. Findings regarding social support and posttraumatic growth need further replication and clarification.

Therapist-Assisted Web-Based Intervention for Prolonged Grief Disorder After Cancer Bereavement: Randomized Controlled Trial.

BACKGROUND: Bereavement due to cancer increases the risk of prolonged grief disorder. However, specialized treatment options for prolonged grief after a loss due to illness are still scarce. OBJECTIVE: The aim of this study is to extend previous findings by evaluating a web-based cognitive behavioral intervention with asynchronous therapist support, consisting of structured writing tasks adapted specifically for prolonged grief after cancer bereavement. METHODS: The intervention was evaluated in a purely web-based randomized waitlist-controlled trial. Open-access recruitment of participants was conducted on the web. Prolonged grief (Inventory of Complicated Grief), depression, anxiety, posttraumatic stress, posttraumatic growth, somatization, sleep quality, and mental and physical health were assessed on the web via validated self-report measures. RESULTS: A total of 87 participants were randomized into the intervention group (IG; 44/87, 51%) or the waitlist control group (43/87, 49%). Of the participants, 7% (6/87) dropped out of the study (5/44, 11%, in the IG). Of the 39 completers in the IG, 37 (95%) completed all intervention tasks. The intervention reduced symptoms of prolonged grief (intention-to-treat: P<.001; η2=0.34; Cohen d=0.80) to a clinically significant extent. It had favorable effects on depression, anxiety, posttraumatic stress, posttraumatic growth, and overall mental health but not on somatization, sleep quality, or physical health. CONCLUSIONS: The web-based intervention for prolonged grief after cancer bereavement is effective in reducing symptoms of prolonged grief disorder and accompanying syndromes in a timely, easily realizable manner and addresses specific challenges of bereavement to illness. Considering web-based approaches in future mental health care policy and practice can reduce health care gaps for those who are bereaved to cancer. TRIAL REGISTRATION: German Clinical Trial Register U1111-1186-6255; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011001.

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.

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.

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.

Syrian refugees in Germany: Perspectives on mental health and coping strategies.

OBJECTIVE: Syrians have been the largest group among asylum seekers in Germany since 2014. Refugees are exposed to various risks along the migration process, indicating the need for adequate psychosocial support. Following the advice of the United Nations High Commissioner for Refugees to consult the target group, this is the first study qualitatively investigating the perspectives on mental health and coping strategies of Syrian refugees in Germany. METHODS: A qualitative design with semi-structured focus group discussions was applied. Three focus groups with a total of N = 20 participants were conducted. Focus group discussions were analyzed using content-structuring content analysis. RESULTS: Hopelessness, fear, and worries were reported most frequently as emotional consequences of war, fleeing, and resettlement, along with cognitive, physical, social, and behavioral consequences. Among the reported consequences, symptoms of PTSD were identified. Contrary to depression and schizophrenia, PTSD was not explicitly mentioned. Possibilities of coping and support referred to meeting basic needs (e.g., mental health care), fostering participation and personal coping, with the social network stated as most important source of support. Barriers of accessing mental health and psychosocial support (MHPSS) services included poor information, stigma, and language difficulties. CONCLUSION: In contrast to earlier research, Syrian refugees reported numerous emotional symptoms as well as mental disorders as consequences of war, fleeing, and resettlement, indicating awareness of mental health sequelae. However, PTSD was not reported as possible consequence. The findings indicate the need for adequate psychoeducation, matching the participants' wish for improved information on mental health to reduce barriers accessing MHPSS.

[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.

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.

Psychosocial outcomes in cancer-bereaved children and adolescents: A systematic review.

OBJECTIVE: Due to the unique importance of parental and sibling relationships and concurrently existing developmental challenges, the loss of a parent or sibling due to cancer is a highly stressful event for children and adolescents. This is the first systematic review that integrates findings on psychosocial outcomes after parental or sibling cancer bereavement. METHODS: A systematic search of Web of Science, PubMed, PsycINFO, and PubPsych was conducted, last in December 2017. Quantitative studies on psychosocial outcomes of children and adolescents who lost a parent or sibling due to cancer were included. RESULTS: Twenty-four studies (N = 10 parental and N = 14 sibling bereavement), based on 13 projects, were included. Ten projects had cross-sectional designs. Only 2 projects used large, population-based samples and nonbereaved comparison groups. Outcomes were partially measured by single-item questions. Bereaved children and adolescents showed similar levels of depression and anxiety compared with nonbereaved or norms. Severe behavioral problems were found rarely. However, in 2 large, population-based studies, about half of the bereaved individuals reported unresolved grief. Bereaved adolescents had a higher risk for self-injury compared with the general population in one large, population-based study. Communication with health-care professionals, family, and other people; social support; distress during illness; age; gender; and time because loss were associated with psychosocial bereavement outcomes. CONCLUSIONS: Results indicate a high level of adjustment in cancer-bereaved children and adolescents. A modifiable risk factor for adverse psychosocial consequences is poor communication. Prospective designs, representative samples, and validated instruments, eg, for prolonged grief, are suggested for future research.

Help-seeking Following Termination of Pregnancy after Diagnosis of Fetal Anomaly: Women's Intentions and Experiences 1 to 7 Years after the Event.

INTRODUCTION: Diagnosis of fetal anomaly and the difficult circumstances involved in the decision to terminate an affected pregnancy can go along with severe psychological distress. However, little is known about women's help-seeking for emotional problems following an abortion after diagnosis of fetal anomaly. METHODS: 148 women who had been treated for abortion after diagnosis of fetal anomaly at the University Hospital Leipzig responded to self-report questionnaires 1 to 7 years after the event. Main outcomes were help-seeking intentions and actual help-seeking behavior. Logistic regression was used to explore the associations between participants' sociodemographic characteristics and help-seeking intentions. RESULTS: Most women reported that they would seek help from their partner (91.7%), friends/family (82.8%) or the internet (62.2%). With regard to health services, 50.0% of women would seek help from gynecologists and between 43.8 and 47.9% from counseling services and mental health professionals. Intentions to seek help from support groups were lowest (21.7%). Age, income, region, and religion were associated with help-seeking intentions. Among participants with elevated levels of current psychological distress, 23.8% indicated that they had not discussed their emotional problems with a health service ever. CONCLUSION: Gynecologists are among the most preferred health professionals for women to discuss psychological problems in the aftermath of an abortion after diagnosis of fetal anomaly. They should be actively involved in screening, diagnostic assessment, and referral of affected women.

Internet-based grief therapy for bereaved individuals after loss due to Haematological cancer: study protocol of a randomized controlled trial.

BACKGROUND: Approximately 10% of the individuals experiencing the death of a loved one develop prolonged grief disorder (PGD) after bereavement. Family members of haematological cancer patients might be particularly burdened since their loss experience is preceded by a very strenuous time of disease and aggressive treatment. However, support needs of relatives of cancer patients often remain unmet, also after the death of the patient. Therapeutic possibilities are enhanced by providing easily available and accessible Internet-based therapies. This study will adapt and evaluate an Internet-based grief therapy for bereaved individuals after the loss of a significant other due to haematological cancer. METHODS: The efficacy of the Internet-based grief therapy is evaluated in a randomized controlled trial with a wait-list control group. Inclusion criteria are bereavement due to hematological cancer and meeting the diagnostic criteria for PGD. Exclusion criteria are severe depression, suicidality, dissociative tendency, psychosis, posttraumatic stress disorder, substance use disorder, and current psychotherapeutic or psychopharmacological treatment. The main outcome is PGD severity. Secondary outcomes are depression, anxiety, somatization, posttraumatic stress, quality of life, sleep quality, and posttraumatic growth. Data is collected pre- and posttreatment. Follow-up assessments will be conducted 3, 6, and 12 months after completion of the intervention. The Internet-based grief therapy is assumed to have at least moderate effects regarding PGD and other bereavement-related mental health outcomes. Predictors and moderators of the treatment outcome and PGD will be determined. DISCUSSION: Individuals bereaved due to haematological cancer are at high risk for psychological distress. Tailored treatment for this particularly burdened target group is missing. Our study results will contribute to a closing of this healthcare gap. TRIAL REGISTRATION: German Clinical Trial Register UTN: U1111-1186-6255 . Registered 1 December 2016.