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The RECLAIM adaptive platform trial for the evaluation of treatments for post-COVID condition in the Netherlands: core protocol.1 month agoPost-COVID condition (PCC) encompasses a heterogeneous spectrum of pathological responses to SARS-CoV-2 infection, with unknown individual predispositions. No evidence-based, curative treatments are available. Many patients therefore resort to off-label use of medications originally developed for other indications. However, the efficacy and safety of repurposed drugs in the context of PCC are unknown.
RECLAIM is a phase III, randomised, controlled, adaptive platform trial. The trial population consists of adult patients who have had persistent PCC symptoms, including fatigue and/or post-exertional malaise, 12 or more weeks after the onset of a SARS-CoV-2 infection. Randomisation occurs within trial domains. A trial domain consists of one or multiple investigational products (IPs), each to be compared to one usual care arm, or one or multiple IPs, each to be compared to a matching placebo. Within each trial domain, patients can be enrolled if they are eligible for at least one IP and its control. They are randomised with equal probability to each arm for which they are eligible. Trial product use (if applicable) starts as soon as possible after randomisation for a default duration of 12 weeks. Study procedures are implemented remotely, using video consultations, eConsenting, trial product delivery to participants' homes (if applicable), and online questionnaires at baseline, day 1, and weeks 2, 4, 6, 8, 10, 12, and 24. The primary outcome is health-related quality of life at week 12, assessed by Patient-Reported Outcomes Measurement Information System Profile29 (PROMIS-29) physical health summary scores, and is analysed with a Bayesian analysis of covariance model with adjustment for the baseline value. Secondary outcomes include week 12 PROMIS-29 mental health summary scores and topic domain scores; specific PCC symptoms using other patient-reported outcome measures, safety, and tolerability; and durability of treatment responses at week 24. Participants are allowed to participate in only one trial domain at a time, but can be rerandomised into a different trial domain after completing week 24.
RECLAIM commenced in February 2025 with an open-label domain including two IP arms (metformin and colchicine) and one usual care control arm. A second placebo-controlled domain, comparing minocycline to a matching placebo, was initiated in February 2026.
European Clinical Trials Information System (CTIS) EUCT number 2024-511580-28-02. Registered on 9 October 2024.
gov identifier NCT07280572. Registered on 11 December 2025.Mental HealthCare/Management -
Discrimination experiences and their associations with sociodemographic factors, health and quality of life-a latent class analysis.1 month agoDiscrimination has adverse effects on people's health and quality of life (QoL). This study aimed to identify distinct intersecting patterns of discrimination experiences, examine their associations with social categories and health factors, and assess the impact of perceived discrimination (PD) on health and QoL outcomes beyond specific self-reported reasons for PD.
We utilized data from the Norwegian Counties Public Health Survey (NCPHS) conducted in Agder County in 2023 and employed latent class analysis (LCA) to explore how patterns of discrimination reasons cluster. The selected classes were then further examined to determine how they differed by comparing each class to the reference class with no PD. Lastly, we assessed the estimated marginal means of each class on health and overall QoL using ANCOVA.
The study identified six classes of PD: Massive PD, Gender/Age PD, No PD, Function/Illness PD, Ethnicity/Skin PD, and Political PD. ANCOVA analyses revealed significant differences across self-rated health, mental distress, and QoL. Notably, the Massive PD, Gender/Age PD, and Function/Illness PD groups reported significantly poorer self-rated health and QoL compared to the No PD group. All PD classes scored significantly higher in mental distress than the No PD group, with the Massive PD class exceeding the clinical cut-off, indicating elevated psychological distress.
Our findings reveal persistent health and QoL disparities between individuals experiencing PD and those who do not, despite a robust welfare system. Service providers must consider the interplay of factors such as age, gender, income, and health conditions with PD to ensure fair service delivery.Mental HealthCare/Management -
Clinical characteristics and risk factors of antipsychotic-associated metabolic syndrome in bipolar disorder: a retrospective analysis.1 month agoMental HealthCare/Management
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Understanding the roles and experiences of mental health peer support workers in England: a qualitative interview study.1 month agoMental HealthCare/Management
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Vital-affective symptom connectivity during electroconvulsive therapy distinguishes depression remission outcomes: A cross-lagged panel network study.1 month agoElectroconvulsive therapy (ECT) is effective for depression, but symptom dynamics during treatment remain unclear. Network approaches may clarify symptom relations and identify patterns linked to remission.
Examining symptom dynamics during ECT using temporal network modeling and comparing baseline and temporal symptom networks between remitters and non-remitters.
Using the Dutch ECT Consortium (N = 857, unipolar/bipolar depression), we examined seven harmonized symptoms from the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Åsberg Depression Rating Scale (MADRS) over the first five weeks of treatment. We estimated baseline networks using partial correlations and temporal networks using Cross-Lagged Panel Network analysis, which quantified each symptom's in-prediction and out-prediction. Between remitters (N = 413) and non-remitters (N = 379), baseline networks were compared using the Network Comparison Test, while temporal networks were compared via network density, Jaccard overlap, and edge correlations.
In the full sample (65.2% female, mean age 61.3 ± 15.5 years), suicidal thoughts exerted the strongest influence on other symptoms (i.e., highest out-prediction). Baseline networks did not differ by outcome, but temporal networks did: remitters showed greater density than non-remitters (χ2 = 8.20, p < 0.01), with low overlap in edges (Jaccard = 0.25), and non-significant edge-weight correlations (r = 0.16; p = 0.46) between groups. Remitters displayed integrated affective-vital symptom connections, while non-remitters showed fragmented subnetworks.
Reductions in suicidal thoughts preceded broader symptom improvements, suggesting this symptom warrants monitoring. Remitters showed coordinated symptom reduction where affective and vital symptoms reinforced each other, while non-remitters showed independent reduction. These findings provide insights into symptom dynamics during ECT.Mental HealthCare/Management -
"Close to the teacher, believe in the teaching": the advantageous effect of interpersonal emotion regulation and the role of teacher-student closeness.1 month agoInteraction is a key element in sustaining the development of human society. The Social Baseline Theory suggests that individuals can regulate emotions through social interactions, thereby promoting physical and mental wellbeing.
This study focuses on the interaction between graduate students and their supervisors within the educational ecosystem, exploring the advantages of interpersonal emotion regulation and the role of teacher-student closeness.
Study 1 recruited 9 university teachers and 58 graduate students, and Study 2 62 of each, with behavioral experiments implemented in both.
The results indicate that, whether employing cognitive reappraisal or expressive suppression strategies, the effectiveness of interpersonal emotion regulation is significantly superior to that of self-emotion regulation. Moreover, higher levels of teacher-student closeness enhance the positive effects of interpersonal emotion regulation on graduate students.
These findings highlight the advantage of interpersonal emotion regulation in teacher-student interactions and emphasize the critical role of high closeness. This study not only provides empirical support for understanding the effectiveness of interpersonal emotion regulation in teacher-student interactions but also offers important theoretical foundations and practical implications for constructing a mental health support system for graduate students.Mental HealthPolicy -
Feasibility, acceptability and initial efficacy of a community-based mental health literacy program delivered by civil society organizations among adults in Kenya: A quasi-experimental study.1 month agoMental health literacy (MHL) strategies are crucial for mental health promotion and prevention. This study aimed to determine the acceptability, feasibility, appropriateness and initial efficacy of an adapted MHL program in a community sample of adults in Kenya. This was a quasi-experimental pre-post study conducted from July 2023 through July 2024. The MHL program contained nine modules delivered over 3 days. Participants were assessed at baseline and immediately after the program. The primary outcomes were mental health knowledge and participants' attitudes on mental health/illness. Secondary outcomes included depressive symptoms, anxiety symptoms, self-perceived social support, self-perceived wellbeing, MHL program acceptability, feasibility and appropriateness. Relative to baseline, we observed statistically significant improvement in mental health knowledge and attitude on mental health/illness postintervention. We also observed significant improvements in all secondary outcomes. The MHL program also emerged as contextually appropriate, acceptable and feasible. The adapted MHL program is acceptable and appropriate and can feasibly be delivered by trained non-specialist facilitators. Also, the MHL program has the potential to increase participants' MHL and attitudes and reduce symptoms of common mental disorders and promote self-perceived wellbeing. Future research should explore how improvements can be sustained over the long term.Mental HealthAdvocacy
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Cancer Control in Refugee and Asylum Seeker Populations: A Scoping Review.1 month agoDisplaced individuals face significant health care access challenges, particularly for noncommunicable diseases. For these individuals, cancer control remains a severely neglected aspect of health care. This scoping review aims to synthesize and evaluate the current state of knowledge on equity within the cancer care continuum for refugee and asylum seeker populations worldwide.
A systematic search of PubMed and Embase was conducted for peer-reviewed articles published between 2000 and 2024, focusing on refugee and asylum seeker populations and cancer. Eligible studies addressed at least one stage of the cancer care continuum (prevention, detection, diagnosis, treatment, end-of-life care or survivorship) and included perspectives or outcomes of patients, caregivers, or providers. Data were extracted and mapped by study setting, population, cancer continuum stage, and type of barriers or interventions identified.
Of 372 screened articles, 111 met inclusion criteria. The majority of research focused on cancer prevention, detection, and diagnosis. Common themes included low cancer awareness, reduced screening uptake, delayed diagnoses, treatment interruptions, and poor survival outcomes. Financial, social, and systemic barriers such as cost, stigma, language barriers, and inconsistent policies were frequently reported. Effective interventions included culturally tailored education, refugee-specific health clinics, use of interpreters, sex-concordant providers, and community engagement.
Refugees and asylum seekers face persistent and multifaceted inequities in cancer care, shaped by both individual and systemic factors. Although some high-performing models and interventions exist, large gaps remain in research and service delivery. The findings emphasize the urgent need for an integrated strategy that incorporates the comprehensive cancer care needs of refugees and asylum seekers into national and international health policies.Non-Communicable DiseasesCancerAccessCare/Management -
Joint modeling of alcohol and tobacco use among adults in Uganda.1 month agoAlcohol and tobacco use are leading modifiable risk factors for non-communicable diseases (NCDs) worldwide. In sub-Saharan Africa, including Uganda, these behaviors are increasingly common but often analyzed separately, limiting understanding of their shared determinants. This study used nationally representative data from the 2014 Uganda WHO STEPS survey to examine individual and joint predictors of current alcohol and tobacco use among adults aged 18-69. Using separate and joint logistic regression models, we assessed associations with demographic, socioeconomic, and health-related factors, applying a shared random effect in the joint model to account for within-individual correlation. The joint model provided better fit (AIC = 6850.13) than the combined separate models (AIC = 6890.73), suggesting a shared latent structure influences both outcomes. Female sex and higher educational attainment were consistently associated with lower odds of substance use, while older age and being separated, divorced, or widowed were linked to higher odds. Smoking-specific interactions showed stronger effects in older and underweight individuals and regional differences were more pronounced for smoking than alcohol. These findings highlight the presence of shared and distinct determinants underlying alcohol and tobacco use in Uganda. While the results suggest potential value in considering these behaviors jointly, further research is needed to evaluate whether integrated intervention strategies are effective in reducing co-occurring substance use.Non-Communicable DiseasesAccessAdvocacy
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Tele-emotion regulation therapy versus tele-guided imagery therapy on sexual performance anxiety in endometrial and ovarian cancer: a randomized clinical trial.1 month agoAdvancements in cancer treatment have led to increasing life expectancy. Few studies have been conducted on sexual anxiety in women affected by gynecologic cancers who suffer from physical (pain, drugs, & surgery) and psychological (shame, fear, & anxiety) consequences. This study aimed to compare Emotion Regulation Therapy (ERT) versus Guided Imagery Therapy (GIT) on sexual anxiety in these women.
A randomized parallel clinical trial was conducted on 64 eligible women who were randomly assigned into either ERT (intervention 1 = 32) or GIT groups (intervention 2 = active control group = 32). Each group received eight 60-min online counseling sessions. The main outcome variable of sexual anxiety was investigated via the Davis questionnaire at baseline, in week 8, and the follow-up in week 12. The secondary outcome variable, i.e., husband's satisfaction with sexual relationship, was measured in weeks 8 and 12.
Intra-group comparison of sexual performance anxiety showed significant decrease in week 12 compared to baseline (ERT: 35.97 ± 5.84, & 61.16 ± 13.84; P = 0.001) (GIT: 35.55 ± 4.79, & 59.84 ± 11.54; P = 0.001), respectively. Inter-group comparison of sexual performance anxiety showed that the scores decreased in both groups in week 12 (ERT: 35.97 ± 5.84 versus GIT: 35.55 ± 4.79) without significant difference (P = 0.297). Intra-group comparison of husband's satisfaction indicated that it was high in both groups without significant difference (ERT week 8: 8.77 ± 1.61, week 12: 9.00 ± 1.41; P = 0.412), (GIT week 8: 8.74 ± 1.00, week 12: 9.16 ± 0.78; P = 0.130), respectively. Inter-group comparison between week 8 (P = 0.297) and week 12 (P = 0.910) showed no significant difference.
Online ERT and GIT were both able to improve sexual anxiety with appropriate partner's satisfaction in these women. Such interventional supports provide more options for better quality of life, especially for women who are unwilling to take psychiatric medications or in other anxiety-provoking situations to reduce anxiety. The application of the findings in the clinical context is related to its usefulness in the integration of care guidelines and treatment plans for these women, as well as by sex therapists, health providers, and health policy-makers.
To conduct the research, the code of ethics: IR.SSU.REC.1401.014 was obtained from the Human Research Ethics Committee of Shahid Sadoughi University dated 05/18/2022; the study protocol was obtained from IRCT dated 06/11/2022 with the registration ID: IRCT20220526054996N1.Non-Communicable DiseasesCardiovascular diseasesCare/ManagementPolicy