Despite the high prevalence of chronic low back pain (cLBP), its underlying mechanisms remain poorly understood. Addressing modifiable psychosocial resources and health behaviours such as physical activity offers a promising avenue for reducing the impact of cLBP. Furthermore, although the relationship between physical activity and pain is theorised as a within-person process, previous research has primarily focused on between-person differences. In this article, we present the protocol for the prospective observational study PRIA (Psychologie und Rückengesundheit im Alltag), which is part of a larger interdisciplinary research consortium investigating preventive, diagnostic and therapeutic aspects of cLBP. Drawing on theories from health and pain psychology, the outlined study examines the interplay between different dimensions of cLBP and back health, physical activity and their psychosocial determinants within individuals in their everyday lives.
This prospective longitudinal study combines online questionnaires with ecological momentary assessment of health behaviours, cognitions, affect, social support and pain using a smartphone-based app (movisensXS) and continuous measurement of physical activity by accelerometry (movisens Move 4). Parameters will be recorded at baseline (T0), daily for the following 14 days (five times per day at 09:00, 12:00, 15:00, 18:00 and 21:00, resulting in up to 70 measurement occasions), 3 and 6 months later (T1 and T2). A total of 230 participants (115 individuals with cLBP and 115 without cLBP) aged 18–64 years will be enrolled. The associations between cLBP and the measured parameters will be examined using multilevel models.
The university’s ethics committee at the MSB Medical School Berlin approved the study on 8 March 2021 (approval number MSB-2021/59, amendment approved on 10 November 2023, amendment number MSB-2023/145). Ethical approval for the FOR 5177 initial screening was granted by Charité – Universitätsmedizin Berlin (EA1/058/21). All participants provided written informed consent. The results of this research will be published in peer-reviewed international journals, presented at national and international conferences, and reported to the German Research Foundation.
DRKS00032978.
Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.
The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.
Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.
CRD420251003208 (preregistered on 10 March 2025).
Forcibly displaced children and adolescents in the WHO European Region have high mental health needs, yet few manage to access mental health services and even fewer receive high-quality care. Addressing this gap is crucial, as inadequate mental health support has profound and lasting negative effects on individuals, families and communities. This scoping review aims to identify and synthesise the available evidence on the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region.
Quantitative, qualitative and mixed-method studies that examine barriers and facilitators of quality mental healthcare for forcibly displaced children and adolescents in the WHO European Region will be included. Eligible participants include forcibly displaced children and adolescents, mental healthcare providers, policymakers and humanitarian actors in the mental health and psychosocial support field. We will adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews) guidelines. A comprehensive search of databases, including Embase, Medline, PsycINFO, Scopus and Web of Science, will be conducted. We will systematically search for relevant studies published between January 2004 and December 2024. At least two reviewers will independently screen titles, abstracts and full texts. Data extraction will involve systematically charting relevant information from included studies. We will use the WHO Quality Standards for Child and Adolescent Mental Health Services as an analytical lens to map the evidence. Our study will provide a comprehensive overview of the barriers and facilitators to quality mental healthcare for forcibly displaced children and adolescents, and identify knowledge gaps and areas for potential quality improvement.
Ethical approval will not be required since this study will retrieve data from already published research and no new data will be collected. The results of this study will be published in a peer-reviewed journal and presented at international conferences in order to disseminate to academic and non-academic stakeholders such as non-governmental organisations, government bodies and community organisations involved in mental healthcare for forcibly displaced persons.
Fostering well-being and positive mental states are major aims of many strategies for the promotion of public mental health. Such strategies become increasingly important since many people worldwide suffer from psychological distress and mental disorders, resulting in substantial individual and societal costs. Within the last years, there is a shift from strategies solely focusing on the reduction of mental distress to those also aiming at the promotion of positive mental states. Correlates, that is, psychosocial resources, of positive mental states may represent a starting point for those interventions. To date, a comprehensive systematic review on those correlates is still missing as well as knowledge on culture-related differences.
A systematic review and meta-analysis on the longitudinal link between psychosocial resources (eg, income, optimism, social support and community coherence) and hedonic and eudaimonic positive mental states (eg, life satisfaction, happiness and forward-looking attitude) will be conducted. Using Hofstede’s dimensions of culture and global metrics of Education, Industrialisation, Richness and Democratic values (EIRDness), we will examine culture-related moderators of these associations. The systematic review will be conducted following standards of the Cochrane Collaboration and will be reported in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyse guidelines. Literature searches for primary studies will be carried out across four databases (APA PsycNet, Embase, Scopus and the Web of Science Core Collection), including all publications up to 27 January 2025. Screening at the level of titles and abstracts will be performed with the help of artificial intelligence software (ASReview). Study quality will be assessed using an adapted version of the Newcastle Ottawa Scale. We will employ multilevel meta-analyses of correlation coefficients, with cultural variables being examined as moderators.
This systematic review does not require ethics approval, as it solely uses previously published data. Materials and data used for this review will be shared via open repositories (https://osf.io/2xkhs/). Results will be published in an international, peer-reviewed journal and presented at conferences including plain language summaries.
To investigate the psychosocial impact of the COVID-19 pandemic on children with chronic health conditions (CHC) and their legal guardians (LG) living in Germany.
Qualitative interview study based on the transcripts of semistructured individual telephone interviews.
Data were collected from October to December 2021 and the time frame of reference was January–June 2021 with two interviewers. Discussed aspects were, for example, socioeconomic information, daily life, thoughts and feelings of both children and LG, as well as family communication, unmet needs and possible advantages. Data were analysed using qualitative content analysis. The category system and subsequent coding schemes with anchor examples were based on interviews and the interview guide. It was tested for integrity and feasibility with one interview and finalised. To ensure classification reliability within all 11 interviews, 1 specifically trained rater (who did not participate in the interviewing to separate data collection and analysis) coded all transcripts.
11 LG of children with CHC participating in the ikidS (ich komme in die Schule) study.
The three aspects that were mentioned most often in the interviews were a psychological impact on children, a psychological impact on LG and an impact on the daily routines of LG. The majority of children and LG were burdened, had changed their activities and spent more time together, while having more conflicts. Children did not worry about becoming infected with COVID-19, but were worried about the health of their relatives. It was further reported that children had become more autonomous. LG additionally reported unmet needs such as opportunities for childcare or psychotherapy.
While the changes brought about by the COVID-19 pandemic and their impact were often seen as negative, the LG in our study also perceived some opportunities for personal development both in their children and themselves, underlining that future research on the impact of the COVID-19 pandemic should focus not only on negative consequences but also on opportunities and positive change. Qualitative methods can be used on an exploratory basis to inform quantitative studies, as they are able to delve deeper into the area being examined and provide greater insight into which aspects interviewees focus on.
Multimorbidity is prevalent and associated with complex treatment requirements. In order to assist general practitioners (GPs) addressing these requirements, the web application gp-multitool.de has been designed, which facilitates implementation of the German clinical practice guideline for multimorbidity. We will conduct a cluster-randomised clinical trial evaluating an intervention based on this tool. This protocol summarises methods and discusses ethics and dissemination of this study.
Participating patients are recruited by cooperating GP practices. Inclusion criteria are an age of 65 years or older, enrolment in any disease management programme and multimorbidity operationalised by two additional chronic conditions. To avoid postrandomisation selection bias, practices are randomised as clusters after baseline assessment of all participating patients from the respective practice. In our intervention, patients receive access to different assessments including patient preferences by email, fill out the electronic assessment forms on any device with access to the internet, receive a medication review and discuss the assessment results with their GPs. GPs in the control group do not have access to the digital tool and provide care as usual. The primary outcome is staying at least once for at least one night in hospital during the 12-month observation period. Secondary outcomes are contacts with GPs and outpatient specialists, self-reported health, health-related quality of life, patient satisfaction and GP-reported and patient-reported quality of care. A sample size of 660 patients from 66 GP practices is needed. Data are analysed by mixed effects regression models.
Ethics approval was obtained by the ethics committee of the Medical Association of Hamburg (2022–1 00 786-BO-ff). Study results will be presented on scientific conferences and published in journal articles. In addition, healthcare professionals, patient representatives and the interested public will be informed about study results at a symposium.
The study was registered in clinicaltrials.gov (NCT06831994).
Prostate cancer (PCa) is the second most common cancer in men worldwide and genetic factors and family history significantly increase the risk of PCa. Men at increased risk for PCa often experience higher PCa-specific anxiety and distress. Comprehensive prevention strategies for men with familial or genetic PCa predisposition are lacking. Consequently, the psychological impact, facilitators and barriers for risk-adapted PCa prevention lack comprehensive study. The novel prospective registry and prevention clinic ‘ProFam-Risk’ (prevention clinic for familial PCa risk) at the University Hospital Düsseldorf offers personalised risk assessment and risk-adapted prevention recommendations for men with familial or genetic PCa predisposition. As part of this research project, this study (‘ProFam-Psych’ - risk-adapted prevention clinic for familial and genetic prostate cancer: psychosocial effects; funded by German Cancer Aid) aims to evaluate the longitudinal psychosocial trajectories associated with this novel prevention clinic.
In a longitudinal observational mixed-methods design, psychosocial outcomes will be assessed in participants of the prevention clinic (case group, CAG) and compared with urology patients without increased risk for PCa (control group, COG). Psychosocial outcomes will be collected at four time points in the CAG (T0: baseline; T1: after first visit; T2: after risk stratification consultation; T3: follow-up 6 months after T2) and at two time points in the COG (T0: baseline during inpatient stay; T1: post-inpatient stay). Recruitment started in 2023, and the recruitment target is n=225 participants (CAG) and n=118 participants (COG). Primary endpoint is the longitudinal course of PCa-specific anxiety (Memorial Anxiety Questionnaire for Prostate Cancer) in the CAG. Secondary endpoints include the comparison of T0 and T1 outcomes between the CAG and COG and the assessment of changes in perceived PCa risk and perceived personal control in the CAG. To assess facilitators and barriers to participation in the risk-adapted PCa prevention clinic, a minimum of n=12 semi-structured qualitative interviews will be conducted, with recruitment continuing until data saturation is reached. Qualitative data will be analysed using qualitative content analysis.
Ethics approval from the Medical Faculty of the Heinrich Heine University Düsseldorf was obtained (2023-2551). Results of the main objective and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
DRKS.de, DRKS00032350. Prospectively registered with the German Clinical Trials Register (DRKS) on 14 September 2023.