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Purpose Inflammation in early childhood has been proposed as a clinically recognized risk factor for developing autism spectrum disorder (ASD). Since vitamin D has an anti-inflammatory role, this trial was aimed to evaluate the effects of vitamin D supplementation on TNF-α and IL-37 status and behavioral problems in children with ASD. Methods This parallel double-blind clinical trial study was conducted on 43 ASD children who were randomly allocated into two studied groups the vitamin D drop group received 300 IU/kg daily ( n  = 22) and, the control group ( n  = 21) for 15 weeks. Serum levels of 25(OH) D (ng/ml), and inflammatory indices including tumor necrosis factor-alpha (TNF-α) (ng/ml), and interleukin 37 (IL-37) (ng/ml) were measured at the start and end of the study. Moreover, the Real-Life Rating Scale for Autism (RLRS) questionnaire assessed behavioral symptoms. Results Of the participants, 55.6% in the intervention group and 44.4% in the control group were boys ( P  = 0.24). After 15 weeks of vitamin D supplementation, serum 25(OH) D levels significantly increased ( P  = 0.001), while TNF-α ( P  < 0.001) and IL-37 ( P  = 0.004) levels significantly decreased. The total RLRS score in the intervention group significantly decreased ( P  = 0.005), but no significant changes were observed in its subcategories (e.g., Sensory Motor Behaviors, Social Relationship to People) due to small, non-significant improvements accumulating to affect the total score. Between-group comparisons for RLRS were non-significant ( P  = 0.165). Conclusion The trial highlighted the possible anti-inflammatory role of vitamin D in children with ASD, as well as improving behavioral disorders. Level of evidence Level I- randomized controlled trial. Trial registration IRCT20170827035936N3, https://irct.behdasht.gov.ir/trial/27012 ; registration date: 16/09/2023.

IntroductionAbout 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.Methods and analysisSystematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.Ethics and disseminationThe results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.PROSPERO registration numberCRD42022332039.

Abstract Introduction: Anxiety sensitivity plays a prominent role in the etiology of anxiety disorders. This construct has attracted widespread interest from experts and researchers. The Anxiety Sensitivity Index (ASI-3) is the most common scale for measuring anxiety sensitivity. Objective: To analyze the psychometric properties and factor structure of the ASI-3 in Iranian student samples. Methods: 220 students (135 women, 85 men) from Kermanshah University of Medical Sciences were selected by the convenience sampling method to evaluate the psychometric properties and analyze the factor structure of the ASI-3. The subjects were also asked to complete the Acceptance and Action Questionnaire-II (AAQ-II), Whiteley Index, Intolerance of Uncertainty, and Neuroticism scales. LISREL and SPSS were used to analyze the data. Cronbach's alpha and correlation coefficients were calculated and confirmatory factor analysis was conducted. Results: The results of the confirmatory factor analysis revealed a three-factor structure with physical, cognitive, and social components (comparative fit index = 0.94; normed fit index = 0.91; root mean square error of approximation = 0.09). The ASI-3 had positive and significant correlations with health anxiety (0.59), intolerance of uncertainty (0.29), and neuroticism (0.51). Furthermore, the ASI-3 had a negative and significant correlation with the AAQII (-0.58). Cronbach's alpha coefficients for the whole scale and for the physical, cognitive, and social concerns factors were 0.90, 0.74, 0.79, and 0.78, respectively. The invariance of the index was significant compared to the original English version. Conclusion: In general, the results support the adequacy of the psychometric properties of the Persian version of the ASI-3. Theoretical and applied implications will be discussed. Resumo Introdução: A sensibilidade à ansiedade desempenha um papel proeminente na etiologia dos transtornos de ansiedade. Esse construto tem atraído grande interesse entre especialistas e pesquisadores. O Anxiety Sensitivity Index (ASI-3; em português, Escala de Sensibilidade à Ansiedade) é a medida mais utilizada para medir sensibilidade à ansiedade. Objetivo: Analisar as propriedades psicométricas e a estrutura fatorial do ASI-3 em estudantes iranianos. Métodos: Para avaliar as propriedades psicométricas e analisar a estrutura fatorial do ASI-3, 220 estudantes (135 mulheres, 85 homens) da Kermanshah University of Medical Sciences, Irã, foram selecionados via amostragem por conveniência. Eles foram solicitados a completar os seguintes instrumentos: Acceptance and Action Questionnaire-II (AAQ-II), Whiteley Index, Intolerance of Uncertainty e Neuroticism. Os programas LISREL e SPSS foram utilizados para analisar os dados. Alfa de Cronbach e coeficientes de correlação foram calculados, e foi realizada análise fatorial confirmatória. Resultados: Os resultados da análise fatorial confirmatória revelaram uma estrutura de três fatores, incluindo componentes físicos, cognitivos e sociais [comparative fit index (CFI) = 0,94; normed fit index (NFI) = 0,91; root mean square error of approximation (RMSEA) = 0,09]. O ASI-3 demonstrou correlações positivas e significativas com ansiedade em relação à saúde (0,59), intolerância à incerteza (0,29) e neuroticismo (0,51). Além disso, o ASI-3 teve uma correlação negativa e significativa com o AAQII (-0,58). Os coeficientes alfa de Cronbach para toda a escala e para os fatores preocupação física, cognitiva e social foram 0,90, 0,74, 0,79 e 0,78, respectivamente. A invariância do índice foi significativa em relação à versão original. Conclusão: Em geral, os resultados sugerem que as propriedades psicométricas da versão persa do ASI-3 são adequadas. Implicações teóricas e práticas serão discutidas.

  Objective: Cognitive-behavioral interventions have been used as effective approaches for the treatment and prevention of depression and anxiety. However, to date, no anxiety and depression prevention guidelines package has been developed for Iranian adolescents. Thus, the purpose of this study was to develop transdiagnostic prevention program of anxiety and depression for Iranian adolescents and to assess the effectiveness of this program in a sample of adolescents. Method: Based on evidence-based literatures on CBT interventions, transdiagnostic prevention program was developed and its content and face validity was assessed and established by three clinical psychologies (Ph.D.) and a psychiatrist (child and adolescent postdoctoral). Then, in a semi-experimental design, 62 students were recruited from a school in Tehran by purposive sampling method and were randomly assigned in to experimental (n = 40) and control (n = 22) groups. They participated in 8 sessions of intervention based on the developed program. Revised Child Anxiety and Depression Scale (RCADS)- Child Version and Parent Version- were used to gather the data before, after, and 3 months after intervention. Results: Results of ANCOVA, controlling for the effect of pretest score, showed no significant differences (P>0.05) between experimental and control groups in SAD, panic, MDD, separation anxiety, GAD, OCD, total anxiety, and total anxiety-depression for parent and child in pretest and posttest. Conclusion: Transdiagnostic prevention package for anxiety and depression had no significant effect on reducing anxiety and depression of adolescents. Using an inappropriate measure, difficulties with timing of assessment, and lower severity of pre-intervention anxiety and depression due to universal prevention and sample recruited, might have affected the present findings. Discussion would be clearer and more complete by analyzing follow-up results and education performance in the future.

Children with autism spectrum disorders (ASD) have lower serum vitamin D and higher serotonin and interleukin (IL)-6 levels compared with healthy children. The aim of this study was to evaluate the effect of vitamin D on core symptoms and serum levels of serotonin and IL-6 in these children. This parallel randomized double-blind, placebo-controlled trial was conducted with 43 children with ASD (7 girls and 36 boys; 8.91 ± 2.87 y of age). Children were randomly allocated to receive either vitamin D drop (300 IU/kg up to a maximum of 6000 IU daily) or placebo for 15 wk. Serum levels of 25-hydroxyvitamin (OH)D, IL-6, and serotonin were measured at baseline and at the end of the trial. Also, the severity of autism and the social and individual maturity of the children were measured by the Childhood Autism Rating Scale (CARS), the Autism Treatment Assessment Checklist (ATEC), and Aberrant Behavior Checklist-Community (ABC-C) questionnaires before and after intervention. Randomization and allocation to groups were done using computer-generated numbers. More than 86% of patients had vitamin D deficiency at the beginning of the study. Serum levels of 25(OH)D increased significantly in the vitamin D group (P = 0.001). The clinical symptoms of autism measured by CARS and ATEC scales were alleviated significantly (P = 0.021 and P = 0.020, respectively); however, the serum levels of serotonin and IL-6 and the scale of ABC-C remained without a significant change. These findings suggest that vitamin D supplementation may improve ASD symptoms; however, more studies with longer duration are indispensable to confirm our results. •In this randomized controlled trial, 86% of patients with autism had the serum 25-hydroxyvitamin D deficiency.•After vitamin D supplementation, the serum 25-hydroxyvitamin D increased.•Clinical symptoms of autism (Childhood Autism Rating Scale and Autism Treatment Evaluation Checklist) were alleviated.•The serum serotonin and interleukin-6 remained without a significant change.

BackgroundNeuropathic pain is a complicated phenomenon in patients with diabetes. These patients have many problems, especially depression and Sleep disturbance. This study aimed to assess the effectiveness of Acceptance and Commitment Therapy on depression and Sleep disturbance in patients with painful diabetic neuropathy.MethodsThe current paper was conducted according to the clinical trial method with 50 participants. Participants were separated into intervention and control groups randomly. Based on the diagnosis of neurologists, all participants received standard medications to regulate neuropathic pain. The intervention group received ACT for eight sessions. The results were evaluated in the pre-test, post-test, and follow-up. The tools used were the Pittsburgh sleep quality index (PSQI) and Beck’s depression inventory. Statistical analysis includes descriptive statistics, and repeated-measures (ANOVA) conducted by SPSS (version 26) software. Results: Results showed that in the intervention group, the treatment led to improved depressive symptoms (F = 6.81, P < 0.05). Besides, for sleep quality, treatment in all subscales, except for the Hypnotic medicine subscale, significantly improved the intervention group’s situations. It was also observed that the overall quality of sleep in the ACT group showed a more significant improvement (P < 0.05). All the above results remained the same until the end of the follow-up period (P < 0.05).ConclusionACT, as a complementary treatment, can improve the psychiatric symptoms and problems in people with neuropathic pain. Therefore, it is necessary to include psychotherapy services along with medical treatment in outpatient and hospitalization units.Trial registration numberIRCT201802050388630N4. Registered in 02/05/2018.

Introduction Neuropathic pain is a complex phenomenon in patients with diabetes. These patients have many problems, such as psychological problems, high-level pain perception, and pain acceptance. This study aimed to evaluate the effectiveness of acceptance and commitment therapy on pain acceptance and pain perception in patients with painful diabetic neuropathy. Methods This study was performed according to the clinical trial method. The sample size was 50 participants. In this study, participants were divided into interventional and control groups. According to the diagnosis of neurologists, all participants received conventional medications to manage neuropathic pain. The intervention group received acceptance and commitment therapy for eight sessions. The results in the three phases of pre-test, post-test, and follow-up were evaluated. After completing the study, to comply with ethical standards, the control group received psycho-education. The tools used were the McGill Pain Questionnaire (MPQ) and the Chronic Pain Acceptance Questionnaire (CPAQ). Statistical analysis includes mean, standard deviation, and repeated-measures (ANOVA) conducted by SPSS software version 22. Results The results demonstrated that in the post-test and follow-up phases, acceptance and commitment therapy could improve pain acceptance and reduce pain perception in the intervention group compared to the control group ( P  < 0.01). Conclusion The results indicated that acceptance and commitment therapy could be used as a psychological intervention besides pharmacotherapy to improve pain acceptance and reduce pain perception in patients with painful diabetic neuropathy. Clinical Trail Registration This study was registered at the Iranian Registry of Clinical Trials (IRCT20180205038630N4).

Abstract Introduction Gross’s Emotion Regulation Questionnaire is one of the most widely-used and valid questionnaires for assessing emotion regulation strategies. The validity and reliability of the Persian version have not been determined and data on its psychometric properties are not available to Iranian mental health researchers. The purpose of this study was to determine the psychometric properties of the Emotion Regulation Questionnaire in Iranian students. Methodology In this cross-sectional study, 348 students (170 males and 178 females) were selected from Shahid Beheshti University of Medical Science and Tehran University of Medical Science. The following statistical procedures were conducted: correlation coefficients, factor analysis, Cronbach’s alpha, and independent t tests. Results The results showed that men use suppression more than women (T = -2.62, p = 0.009). Cronbach’s alpha coefficients were 0.76 for the cognitive reappraisal sub-scale and 0.72 for the suppression sub-scale (excluding question 9). Six questions related to the cognitive reappraisal factor explained 30.97% of emotion regulation variance, and 3 questions related to the suppression factor explained 22.59% of emotion regulation variance. Overall, these factors explained 53.5% of emotion regulation variance. There were significant correlations between suppression and difficulties in emotion regulation, trait anxiety, and affective control. Furthermore, there was a significant correlation between cognitive reappraisal and the Five-Facet Mindfulness Questionnaire. Conclusion The results indicate that the Persian version of the ERQ is a reliable and valid instrument that can be helpful for development of further important studies of emotional regulation.