title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Internalization | The LMM with baseline internalization as a covariate, randomized group as a between-subjects factor, study phase (T2 and T3) as a within-subjects factor, three 2-way interactions, and one 3-way interaction found a nonsignificant effect of group (The preplanned ANCOVAs showed a significant effect of randomized group on ... | PMC10131926 | ||
Skin Shade Dissatisfaction | The complete LMM conducted on skin shade dissatisfaction showed a nonsignificant effect of group (The preplanned ANCOVAs showed a significant effect of randomized group on skin shade dissatisfaction at T2 (The post hoc repeated measures ANOVAs showed no significant effect of time in the control group (Trait skin shade ... | PMC10131926 | ||
Negative Mood | The LMM with baseline negative mood as a covariate, randomized group as a 2-level between-subjects factor, study phase (T2 and T3) as a 2-level repeated measures factor, three 2-way interactions, and one 3-way interaction showed a nonsignificant effect of group (The preplanned ANCOVAs confirmed the previous results, fi... | PMC10131926 | ||
Positive Mood | The LMM conducted on positive mood showed a nonsignificant effect of group (The preplanned ANCOVAs confirmed these results, finding a nonsignificant effect of randomized group on positive mood at both T2 ( | PMC10131926 | ||
Dose-Response Analyses | REGRESSION | Dose-response effects on trait outcomes at T2 and T3 in the intervention group were examined by running multiple regression analyses with Helmert-coded engagement scores (ie, the number of videos watched) as independent variables. The analyses showed no dose-response for all trait outcomes at any time point: body satis... | PMC10131926 | |
State Outcomes | PMC10131926 | |||
State Mood | Six dependent sample Cumulative analyses showed a significant interaction effect (The repeated measures ANOVA on prevideo scores was significant (Plotted means for state mood in the intervention group with prevideo and postvideo means for each video. | PMC10131926 | ||
Exploratory Analyses | On the basis of these findings, exploratory analyses were conducted to test whether the observed delayed effect on trait body satisfaction could be mediated by the immediate effect that the intervention had on internalization. Such a finding would provide support for the relationship between these variables as defined ... | PMC10131926 | ||
Discussion | PMC10131926 | |||
Intervention Effectiveness on Trait Outcomes | CURB | Scalable, cost-effective, and evidence-based interventions to curb body dissatisfaction are necessary and in demand among adolescent girls and young Indonesian women [In this study, we found Interestingly, the impact of In addition to the role that internalization played as a mediator of body satisfaction, our hypothes... | PMC10131926 | |
Dose-Response Effects | Intervention adherence was excellent, with intervention participants having watched an average of 5 out of the 6 videos and completed, on average, 14 of the 18 activities. These adherence results are much higher than those often observed in web-based psychological interventions [ | PMC10131926 | ||
Intervention Effectiveness on State Outcomes | Overall, the effectiveness of Gain score comparisons within cumulative analyses showed that state-based improvements in body satisfaction were particularly strong for videos 1 (setting the scene), 3 (targeting appearance-based comparisons), 5 (targeting self-body talk), and 6 (concluding the story), and for state mood,... | PMC10131926 | ||
Strengths | Notable strengths of our study include excellent participant retention and intervention adherence, which are unusual for eHealth intervention trials [ | PMC10131926 | ||
Limitations | There are a few key areas that future research could explore. First, funding constraints prevented us from evaluating the independent impact of the intervention’s videos versus the combined impact of videos and activities. This is an area for future research. Second, although social comparisons are a potentially import... | PMC10131926 | ||
Conclusions | PCD | This parallel randomized controlled trial showed that This study was funded by a research grant from the Dove Self-Esteem Project (Unilever). The funder had no role in the data analysis, decision to publish, or manuscript preparation.We would like to especially thank Laura Baines (Girl Effect) and Samantha Jackson (Per... | PMC10131926 | |
Abbreviations | analysis of covarianceBody Esteem Scale for Adolescents and Adultslog likelihoodlower- and middle-income countrylinear mixed modelPositive and Negative Affect Schedule for Childrenparticipant identification numberSociocultural Attitudes Towards Appearance Questionnairetime 1, baselinetime 2, 1 day after the interventio... | PMC10131926 | ||
Background | TNBC | TRIPLE-NEGATIVE BREAST CANCER | Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of stages II and III triple-negative breast cancer (TNBC). This study aims to evaluate if the addition of carboplatin to NACT is associated with an increase in the pathological complete response (pCR) rates in TNBC. | PMC10504209 |
Methods | TNBC | We conducted an open-label phase II randomized clinical trial in a single center in Brazil. Patients with stage II and III TNBC were randomized to receive standard NACT with or without carboplatin. All the patients received doxorubicin (60 mg/m | PMC10504209 | |
Results | tumors, Germline BRCA status | DISEASE, TUMORS | Between 2017 and 2021, 146 patients were randomized, 73 on each arm. The median age was 45 years. Most patients (66.4%) had locally advanced stage III disease, 67.1% had T3/T4 tumors, and 56.2% had clinically positive axillary lymph nodes. Germline BRCA status was available for all patients, and 19.9% had pathogenic | PMC10504209 |
Conclusion | TNBC | The addition of carboplatin to standard NACT in stages II and III TNBC was associated with a non-statistically significant numerical increase in the pCR rate. Follow-up for survival outcomes and translational research initiatives are ongoing. | PMC10504209 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s10549-023-07011-0. | PMC10504209 | ||
Keywords | PMC10504209 | |||
Introduction | TNBC, tumor, death, breast cancer | TRIPLE-NEGATIVE BREAST CANCER, TUMOR, BREAST CANCER, DISEASE, DYSFUNCTION | Triple-negative breast cancer (TNBC) is a subtype that accounts for approximately 15–20% of all breast cancer diagnoses. Clinically defined as lacking ER, PR, and HER2 expression, TNBC is characterized by an aggressive natural history and worse survival outcomes compared with other breast cancer subtypes [Neoadjuvant c... | PMC10504209 |
Methods | Cancer | CANCER | NACATRINE is an open-label phase II randomized trial conducted in a single center in Brazil. The study was conducted in compliance with the guidelines of the Declaration of Helsinki, International Conference on Harmonization and Good Clinical Practice. All patients gave informed consent for using tissue and biomarker e... | PMC10504209 |
Patient population | TNBC | Key eligibility criteria included patients more than 18 years old, with ECOG PS 0 or 1, adequate organ function with newly diagnosed stage II–III TNBC (ER < 1%, PR < 1%, and HER2 negative according to ASCO/CAP Guidelines [ | PMC10504209 | |
Randomization and stratification | All eligible patients were randomized in a 1:1 ratio to receive standard NACT with or without carboplatin. Treatment was allocated by computerized local randomization using the REDCAP (Research Electronic Data Capture) software. Randomization was stratified according to | PMC10504209 | ||
Procedures | neutropenia, toxicity, toxicities, clinically node-negative disease, anemia, Cancer | ADVERSE EVENT, METASTASIS, NEUTROPENIA, FEBRILE NEUTROPENIA, ADVERSE EVENT, THROMBOCYTOPENIA, DISEASE, ANEMIA, SENTINEL NODE, BLOOD, CANCER | All women were screened at baseline for distant metastasis with chest and abdomen tomography and bone scintigraphy. Blood samples were collected from all women at baseline to define BRCA1 and BRCA2 mutational status and storage at the BioBank of Barretos Cancer Hospital [According to the investigator's choice, a sentin... | PMC10504209 |
Outcomes | tumor | TUMOR | The primary endpoint was the pathologic complete response (pCR) rate. pCR was defined as no invasive tumor in the breast and lymph nodes (ypT0ypN0) and followed international guidelines [Additionally, biological samples were collected during the study to conduct molecular and clinical analyses to assess the presence of... | PMC10504209 |
Statistical analysis | We hypothesized that the carboplatin-containing neoadjuvant regimen could increase the pCR rate from 20 to 35% compared with the non-carboplatin neoadjuvant-containing regimen. Safety data were summarized descriptively for all patients who received at least one dose of study treatment. TEAEs leading to treatment interr... | PMC10504209 | ||
Role of the funding source | The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. | PMC10504209 | ||
Discussion | neutropenia, toxicity, TNBC, hereditary mutations, tumors | RECURRENCE, NEUTROPENIA, DNA STRAND BREAK, DISEASE, ADVERSE EFFECTS, TUMORS | In the NACATRINE study, a phase II randomized clinical trial conducted at a single center in Brazil, the addition of carboplatin to an anthracycline and taxane-based NACT regimen was associated with a numerical but not statistically significant increase in the pCR rate. Survival data are immature and, so far, do not sh... | PMC10504209 |
Conclusion | TNBC | The addition of carboplatin to standard NACT in stages II and III TNBC was associated with a non-statistically significant numerical increase in the pCR rate of 13.7%, consistent with other similar clinical trials. Follow-up for survival outcomes and translational research initiatives are ongoing. Given the consistent ... | PMC10504209 | |
Acknowledgements | Cancer | RECRUITMENT, CANCER | The authors would like to thank the BioBank of the Barretos Cancer Hospital for the technical support in handling biological samples from the patients, the Researcher Support Center (NAP) for the support with the recruitment of clinical trial participants, and the Barretos Cancer Hospital Research Incentive Program (PA... | PMC10504209 |
Author contributions | DCL | CPS | ASBC recruited the patients and participated in the study design. ACOL participated in the study design. DCL recruited the patients. CEP recruited patients and participated in the study design, preparation, and critical reading of the manuscript. MMCZ recruited the patients. AJAF participated in the manuscript preparat... | PMC10504209 |
Funding | This clinical trial received funding from the Department of Science and Technology—DECIT, Brazilian Ministry of Health (Grant No. 879848/2018). | PMC10504209 | ||
Data availability | The data generated in this study are available upon request from the corresponding author. | PMC10504209 | ||
Declarations | PMC10504209 | |||
Conflict of interest | The authors declare no potential conflicts of interest. | PMC10504209 | ||
References | PMC10504209 | |||
Background | GASTROINTESTINAL DISORDERS | Oral microbial therapy has been studied as an intervention for a range of gastrointestinal disorders. Though research suggests that microbial exposure may affect the gastrointestinal system, motility, and host immunity in a pediatric population, data have been inconsistent, with most prior studies being in neither a ra... | PMC10313516 | |
Methods | Sixty-four children (3–17 years of age) were randomized to receive a synbiotic ( | PMC10313516 | ||
Results | Treatment increased ( | PMC10313516 | ||
Conclusions | These findings suggest the potential for (i) multi-species-synbiotic interventions to improve digestive health in a pediatric population and (ii) bioinformatics-based methods to predict response to microbial interventions in children. | PMC10313516 | ||
Impact |
Synbiotic microbial treatment improved the number of spontaneous weekly bowel movements in children compared to placebo.Intervention induced an increased abundance of bifidobacteria in children, compared to placebo.All administered probiotic species were enriched in the gut microbiome of the intervention group compare... | PMC10313516 | ||
Background | nine-strain, constipation | Recent advances in microbiome tools (e.g., culturing, bioinformatics) have enabled a deeper understanding of microbial ecology and the gut microbiome’s role in human health. Gastrointestinal microbes exert functional influence on the host through a range of metabolic and immunological mechanisms, and the host shapes re... | PMC10313516 | |
Methods | PMC10313516 | |||
Study design and primary objective | The clinical trial was IRB-approved, multicenter, randomized, double-blind, and placebo-controlled with two parallel arms (ClinicalTrials.gov identifier NCT04534036). Following a run-in period of 14 days, subjects were randomly assigned to an intervention and placebo arm for a duration of 84 days. “Constipated” was def... | PMC10313516 | ||
Randomization and patient selection | A standardized treatment effect of 0.6 in Bristol Stool Form Scale change was estimated. Based on this anticipated treatment effect, a sample size of 43 per arm was needed to achieve 85% power. This number was increased to >100 to account for attrition. In total, 121 healthy male/female subjects were assessed for eligi... | PMC10313516 | ||
Randomized, placebo-controlled clinical design. | ADVERSE EVENTS | CONSORT diagram indicating clinical trial design and execution.Cohort characteristics.Allocation, randomization, blocking, and blinding were executed by a Contract Research Organization. 1:1 randomization was done via a computer-generated sequence (with the expectation of normal age distribution in the active and place... | PMC10313516 | |
Intervention | The interventional composition consisted of 6.2 g of mixed-chain length prebiotic substrates suspended in a single sachet with nine microbial strains (>10 | PMC10313516 | ||
Statistical analysis of clinical data | ADVERSE REACTIONS, REGRESSION | Analyses of clinical outcomes were performed using SASIn relation to WBM frequency, we considered two sub-cohorts as presenting with clinically relevant bowel movement patterns at baseline, defined as children with <4 WBMs and children with <5 WBMs. This second cohort is a superset of the first. In other words, the pop... | PMC10313516 | |
Metagenomic sequencing | HT | Fecal samples were extracted by Diversigen with PowerSoil Pro (Qiagen) automated for high throughput on the QiaCube HT (Qiagen), using Powerbead Pro Plates (Qiagen) with 0.5 and 0.1 mm ceramic beads. Samples were quantified with Quant-iT PicoGreen dsDNA Assay (Invitrogen). Libraries were prepared with a procedure adapt... | PMC10313516 | |
Diversity and microbiome feature abundance quantification | All shotgun metagenomic sequencing was quality-controlled prior to analysis. We executed all quality control with a combination of bbtoolsAnnotation of microbial taxa, pathways, and gene family abundances was performed using MetaPhlAn3 and HUMAnN3 running the default settings.Shannon and Simpson diversity were computed... | PMC10313516 | ||
Quantification and comparisons of bifidogenic and probiotic strain abundance | We next aimed to compute the relative abundances of particular strains of interest in our active versus treatment metagenomes at baseline and endpoint. Specifically, these organisms were (i) microbial strains administered in the active formulation, and, (ii) all members of the We used a portion of Anvi’o’s metapangenom... | PMC10313516 | ||
Metagenome association study (MAS) on microbiome feature abundances | bloating, pain | REGRESSION, REGRESSIONS | We executed a MAS between microbial feature (i.e., taxon/pathway) abundance and responder status, treatment, bloating, pain, and weekly/change in bowel movements. We looked at associations between these clinical variables and microbial feature abundances at baseline/endpoint where relevant (e.g., we did not compute the... | PMC10313516 |
Results | PMC10313516 | |||
Synbiotic use increases weekly bowel movements in constipated children compared to placebo | non-constipated | We aimed to estimate the increase in WBMs across the entire cohort, including both constipated and non-constipated individuals. We recruited 121 individuals, 30 of which were excluded prior to the study beginning (see Methods). A total of 64 (33 active and 31 placebo) returned for the day 84 timepoint (Fig. Response ra... | PMC10313516 | |
Increased abundance of the administered probiotic species in the treatment arm | constipation | We next aimed to investigate microbiome changes as a function of treatment and response to treatment. We received stool samples from 52 individuals at both the baseline and day 84 timepoints. We carried out shotgun sequencing on these samples in an effort to estimate their microbiome composition as a function of treatm... | PMC10313516 | |
Limited features are significantly altered in treatment or constipation-associated phenotypes in this study | bloating, pain | REGRESSION | Via a discovery-driven MAS, we aimed to determine if the abundance of specific taxonomies or pathways was altered at baseline versus the endpoint as a function of treatment, bloating, pain, and WBMs. Adjusting for age and baseline WBMs, we used logistic regression to evaluate the association between baseline abundance ... | PMC10313516 |
Response rate to probiotic treatment is contingent upon species richness | REGRESSION | We next computed alpha diversity using Shannon, Simpson, and taxonomic richness metrics at the phylum, class, order, family, genus, and species levels for all samples. This was done using Wilcoxon tests to compare variation in each of these three metrics between baseline and endpoint for non-responders and responders a... | PMC10313516 | |
Discussion | constipation | ADVERSE EFFECTS, DISEASE | This placebo-controlled, randomized clinical trial demonstrated that a novel synbiotic formulation increased weekly WBMs in children who had low-frequency WBMs at baseline. We additionally characterized the microbiome in individuals who received and responded to treatment versus those who did not, identifying microbial... | PMC10313516 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41390-022-02289-0. | PMC10313516 | ||
Author contributions | B.T.T. led bioinformatic analysis and manuscript drafting without involvement in trial design. C.E.M. and R.D. designed the bioinformatic strategy and participated in data analysis and manuscript drafting. B.P.C. contributed to the manuscript review from a functional assessment and clinical perspective. J.V. contribute... | PMC10313516 | ||
Funding | This work was funded by Seed Health (SH). SH funding contributed towards study design, microbiome sequencing, bioinformatics, and manuscript preparation. | PMC10313516 | ||
Data availability | All software used in this project is available at | PMC10313516 | ||
Competing interests | FOUNDER, APC, BLOOM | B.T.T. and G.S. led data analysis and were not involved in study design or trial execution. R.D. is a co-founder and CEO of Seed Health (SH) and Luca Biologics. J.V., A.F., E.A.M., C.E.M., and J.F.P. are members of the SH Scientific board. SH Scientific board members and employees hold equity positions in SH unless ot... | PMC10313516 | |
Consent for publication | Patient consent was required and received for this clinical trial and publication. | PMC10313516 | ||
References | PMC10313516 | |||
Background | migraine, Migraine, migraine-related | DISABLING DISEASE, MIGRAINE, IRON DEPOSITION, MIGRAINE | Migraine is one of the world’s most prevalent and disabling diseases. Despite huge advances in neuroimaging research, more valuable neuroimaging markers are still urgently needed to provide important insights into the brain mechanisms that underlie migraine symptoms. We therefore aim to investigate the regional iron de... | PMC10080952 |
Methods | migraine, Headache, Migraine, CM | MIGRAINE, MIGRAINE, IRON DEPOSITION | A total of 200 migraineurs (56 chronic migraine [CM], 144 episodic migraine [EM]) and 41 matched controls were recruited. All subjects underwent MRI and clinical variables including frequency/duration of migraine, intensity of migraine, 6-item Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS), and Pi... | PMC10080952 |
Results | CM | DISEASE PROGRESSION, IRON DEPOSITION | Increased iron deposition in the putamen, caudate, and nucleus accumbens (NAC) was observed in migraineurs more than controls. Meanwhile, patients with CM had a significantly higher volume of iron deposits compared to EM in multiple subcortical nuclei, especially in NAC. Volume of iron in NAC can be used to distinguish... | PMC10080952 |
Conclusions | migraine, migraine-related dysfunctions | MIGRAINE, IRON DEPOSITION | These findings provide evidence that iron deposition in NAC may be a biomarker for migraine chronicity and migraine-related dysfunctions, thus may help to understand the underlying vascular and neural mechanisms of migraine. | PMC10080952 |
Trial registration | ClinicalTrials.gov, number NCT04939922. | PMC10080952 | ||
Keywords | PMC10080952 | |||
Background
| migraine, Migraine, CM | DISORDER, DISEASE COURSE, PATHOPHYSIOLOGY, MIGRAINE, MIGRAINE, IRON DEPOSITION | Migraine is a highly prevalent disorder that imposes an enormous socioeconomic burden. While patients with chronic migraine (CM) only account for 1.4–2.2% of the general population globally [The pathophysiology of migraine involves both vascular and neural mechanisms [Using non-invasive techniques such as T2-weighted a... | PMC10080952 |
Methods | PMC10080952 | |||
Participants | migraine, obesity, CM | INFECTIOUS DISEASES, OBESITY, HEADACHE DISORDERS, HYPERCHOLESTEROLEMIA, SYSTEMIC DISEASE, CORONARY DISEASE, DIABETES MELLITUS, MIGRAINE, HIGH BLOOD PRESSURE | This study was approved by the local Institutional Review Board, and written informed consents were obtained from all participants. From September 2021 to January 2023, individuals diagnosed with EM or CM according to the International Classification of Headache Disorders, 3rd edition criteria were selected.Patients we... | PMC10080952 |
Clinical assessment | Headache, migraine-related functional disability, headache pain, migraine, Migraine | MIGRAINE, MIGRAINE | All subjects underwent a medical interview including demographic data (age, sex) and personal family histories. For migraineurs, disease duration (measured in years from first symptoms), frequency of migraine attacks per month, migraine days per month, and peak headache pain intensity (measured by visual analog scale (... | PMC10080952 |
Image Acquisition | All the MR images were acquired using a United Imaging MR790 3.0 T scanner (Shanghai, China). T1 weighted images were acquired with a 3D fast spoiled gradient-echo sequence; the parameters were: TR = 6.9 ms, TE = 2.9 ms, flip angle = 9°, inversion time = 1000 ms, field of view = 256 × 240 mm, voxel size = 1 × 1 × 1 mm | PMC10080952 | ||
Image processing | The QSM images were reconstructed from GRE data using the SEPIA (SuscEptibility mapping PIpeline tool for phAse images) toolbox [The magnitude image, in the same space as the QSM image, was used for registration and was obtained by summing the squares of magnitude images among different TEs. 3D T1, T2, and magnitude im... | PMC10080952 | ||
Statistical analysis | migraine, CM | MIGRAINE, DISEASE | Sex was recorded as binary variables. Age, disease duration, migraine attacks per month, disease duration, migraine days per month, VAS, HIT-6, MIDAS, and PSQI were recorded as continuous variables, and one-sample Kolmogorov–Smirnov test was used to check the normality of all continuous variables. Demographics and clin... | PMC10080952 |
Results | PMC10080952 | |||
Regional comparisons of iron-related metric between groups | Significantly higher QSM value was observed in Pu (Iron content (measured by QSM value) distributions in the putamen, caudate, and nucleus accumbens among three groups. * indicates the significant difference ( | PMC10080952 | ||
ROC analysis of the QSM value | After calculation of receiver operating characteristic curves (Fig. Receiver operating characteristic (ROC) curves for iron deposits in nucleus accumbens (NAC). | PMC10080952 | ||
Relationship between iron-related metric and clinical variables | Headache, Migraine | DISEASE, MIGRAINE | In migraineurs, the QSM values of NAC were significantly associated with longer disease duration (Correlation between iron deposits in nucleus accumbens (NAC) and clinical variables in migraineurs. HIT-6, The 6-item Headache Impact Test; MIDAS, Migraine Disability Assessment; PSQI, Pittsburgh Sleep Quality Index | PMC10080952 |
Discussion | neuroinflammation, central pain, migraine-related functional disability, pain, CM, headache-related disability, migraine | MIGRAINE, DISEASE, IRON DEPOSITION | Our study demonstrated that migraineurs had increased iron deposition in Pu, Ca, and NAC than healthy controls. Meanwhile, patients with CM had a significantly higher volume of iron deposits in multiple subcortical brain nuclei including Pu, Ca, NAC, SNc, PBP, and HN compared to EM. Volume of iron in NAC can be used to... | PMC10080952 |
Limitations | depression | Despite the novelty of the current study, this prospective study is still prone to several limitations. One important limitation is the fact that our results are based on cross-sectional observation, longitudinal data are needed to justify a such conclusion. Second, the current study included patients across a wide age... | PMC10080952 | |
Conclusions | migraine, disability, migraine-related disability, CM | PATHOPHYSIOLOGY, DISEASE, MIGRAINE, IRON DEPOSITION | In conclusion, we have successfully demonstrated that there is an increased iron deposition in multiple subcortical nuclei, especially NAC, in patients with CM, and the regional iron accumulation level in NAC could be used to distinguish CM patients from EM. More importantly, the increased iron deposition in NAC was as... | PMC10080952 |
Acknowledgements | We thank all migraineurs and their families who were involved in this study. | PMC10080952 | ||
Authors’ contributions | RECRUITMENT | XXP and LKM designed the study. XXP wrote the first draft of the manuscript. XXP, ZMT, and WX collected the clinical and MRI data. ZFL, HJH, and CHR assisted with patient recruitment. LX, LKC, ZQZ, GXJ, HPY, ZMM, and LKM assisted with the research design. All authors contributed to the final manuscript. All authors rea... | PMC10080952 | |
Funding | This study was supported by the National Natural Science Foundation of China (Grant No. 82001766). | PMC10080952 | ||
Availability of data and materials | The data that support the findings of this study are not publicly available due to privacy or ethical restrictions. Data are however available from the corresponding authors upon reasonable request and with permission after the completion of the study. | PMC10080952 | ||
Declarations | PMC10080952 | |||
Ethics approval and consent to participate | The experimental protocol was established, according to the ethical guidelines of the Helsinki Declaration and was approved by the Human Ethics Committee of Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine (IRB2021001248). Written informed consent was obtained ... | PMC10080952 | ||
Consent for publication | Not applicable. | PMC10080952 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10080952 | ||
References | PMC10080952 | |||
Background | depression, anxiety | Repetitive negative thinking (RNT) is a key transdiagnostic mechanism underpinning depression and anxiety. Using “just-in-time adaptive interventions” via smartphones may disrupt RNT in real time, providing targeted and personalized intervention. | PMC10753417 | |
Objective | depression, anxiety | This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical outcomes and mechanisms of Mello—a fully automated, personalized, transdiagnostic, and mechanistic smartphone intervention targeting RNT in young people with depression and anxiety. | PMC10753417 | |
Methods | heightened depression, anxiety | Participants with heightened depression, anxiety, and RNT were recruited via social media and randomized to receive Mello or a nonactive control over a 6-week intervention period. Assessments were completed via Zoom sessions at baseline and at 3 and 6 weeks after baseline. | PMC10753417 |
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