Intervention Trial Research Articles

Lessons Learned from a Community-led, Pilot Teletherapy Group for Older Women Living with Depression and HIV.

Older women with HIV face challenges to their quality of life, including neurocognitive decline, early-onset menopause, and chronic health issues. Chief among these concerns is depression, the most common psychiatric comorbidity among people living with HIV, with rates twice as high among women as men. However, tailored interventions among older women living with HIV and depression are lacking. Following the ADAPT-ITT framework to adapt existing interventions for cultural relevance among groups of people living with HIV, the study team revised an evidence-based intervention, the 'Stress Management and Relaxation Training/Expressive Supportive Therapy Women's Project (SMART/EST),' for online implementation. Working with two community stakeholders, the study team conducted focus groups, theater testing, and manual adaptation. This resulted in the development of e-SMART/EST, an online teletherapy group co-facilitated by a Licensed Psychologist and a credentialed Peer Counselor. The adapted, eight-session weekly intervention was tested with an exploratory pilot sample of eight older women (55 years and older) with HIV and depression. Participants rated the acceptability, feasibility, and appropriateness of the intervention, as well as symptoms of depression and HIV-related quality of life before and after the group. The e-SMART/EST Women's Project demonstrated high acceptability, feasibility, and appropriateness. Engagement was high, as women attended an average of 6.8 sessions. In qualitative interviews, participants reported peer co-facilitation, culturally relevant themes (e.g., HIV-related minority stress, critical consciousness, grief, and sex and pleasure), mindfulness techniques, and cohesion with other women as main favorable elements of the intervention. Barriers to online implementation included technological issues, distractions due to remote participation, and hindered emotional attunement compared with in-person group therapy. Findings support further research to test similar interventions in full-scale trials with older women living with depression and HIV.

Association between in vitro susceptibility and clinical outcomes in fungal keratitis.

The purpose of this study was to assess the association between antifungal susceptibility as measured by minimum inhibitory concentration (MIC) and clinical outcomes in fungal keratitis. This pre-specified secondary analysis of the Mycotic Ulcer Treatment Trial II (MUTT II) involved patients with filamentous fungal keratitis presenting to Aravind Eye Hospitals in South India. Antifungal susceptibility testing for natamycin and voriconazole was performed on all samples with positive fungal culture results according to Clinical and Laboratory Standards Institute Guidelines. The relationship between MIC and clinical outcomes of best-corrected visual acuity, infiltrate or scar size, corneal perforation, need for therapeutic penetrating keratoplasty, and time to re-epithelialization were assessed. We obtained MIC values from 141 patients with fungal keratitis. The most commonly cultured organisms were Aspergillus (46.81%, n = 66) and Fusarium (44.68%, n = 63) species. Overall, there was no association between antifungal MICs and clinical outcomes. Subgroup analysis revealed that among Fusarium-positive cases, higher voriconazole MIC was correlated with worse three-month best-corrected visual acuity (p = 0.03), increased need for therapeutic penetrating keratoplasty (p = 0.04), and time to re-epithelialization (p = 0.03). No significant correlations were found among Aspergillus-positive cases. There were no significant correlations found between natamycin MIC and clinical outcomes among organism subgroups. Decreased susceptibility to voriconazole was associated with increased odds of requiring a therapeutic penetrating keratoplasty in Fusarium-positive cases. Susceptibility to natamycin was not associated with any of the measured outcomes.

A randomized controlled trial of a housing intervention to reduce endocrine disrupting chemical exposures in children

A randomized controlled trial of a housing intervention to reduce endocrine disrupting chemical exposures in children

A randomized controlled trial of a brief self-directed secular REACH Forgiveness intervention with Indonesian Christians: Does religiousness matter?

A randomized controlled trial of a brief self-directed secular REACH Forgiveness intervention with Indonesian Christians: Does religiousness matter?

Current development of molecular classifications of gastric cancer based on omics (Review).

Gastric cancer (GC) is a complex and heterogeneous disease with significant phenotypic and genetic variation. Traditional classification systems rely mainly on the evaluation of clinical pathological features and conventional biomarkers and might not capture the diverse clinical processes of individual GCs. The latest discoveries in omics technologies such as next‑generation sequencing, proteomics and metabolomics have provided crucial insights into potential genetic alterations and biological events in GC. Clustering strategies for identifying subtypes of GC might offer new tools for improving GC treatment and clinical trial outcomes by enabling the development of therapies tailored to specific subtypes. However, the feasibility and therapeutic significance of implementing molecular classifications of GC in clinical practice need to addressed. The present review examines the current molecular classifications, delineates the prevailing landscape of clinically relevant molecular features, analyzes their correlations with traditional GC classifications, and discusses potential clinical applications.

Effects of multi-component parenting and parental mental health interventions on early childhood development and parent outcomes: a systematic review and meta-analysis

Interventions supporting parents of young children often target parenting or parental mental health separately. Multi-component parenting and parental mental health interventions have the potential to improve parenting practices, mental health, and early childhood development. We aimed to examine their impact on child and parent outcomes. In this systematic review and meta-analysis, we searched MEDLINE, Embase, Web of Science Core Collection, APA PsycINFO, CINAHL Complete, the Cochrane Central Register of Controlled Trials, and the Global Health Database from inception to Jan 23, 2024. Eligible studies were randomised controlled trials of interventions explicitly targeting parenting behaviours and parental mental health antenatally or in children's first 3 years of life. Screening, extraction, and quality assessment were done independently by two authors. Primary outcomes were cognitive and social-emotional functioning in children and depressive symptoms in parents, meta-analysed as standardised mean differences (SMDs), relative to control. This study is registered with PROSPERO, CRD42022302848. We found 5843 records. After screening 2636 (45·1%) titles and abstracts, we manually identified and screened three additional articles and excluded 2177 records. After screening 462 full-length articles, 25 articles, representing a sample size of 8520 children and caregivers, were included. At baseline, mean caregiver age was 27·7 years (SD 5·9) and mean child age (excluding those enrolled during pregnancy) was 14·4 months (8·0). Interventions lasted a mean of 14 months (SD 11) and used a mean of 3·7 behaviour change techniques (2·0). Most interventions dedicated more time to parenting behaviours than to parental mental health. We found significant intervention effects on children's cognitive (SMD 0·19 [95% CI 0·04 to 0·34]; I2=69%) and social-emotional (0·26 [0·17 to 0·34]; I2=47%) outcomes but not on depressive symptoms in female caregivers (-0·18 [-0·36 to 0·002]; I2=86%) relative to control conditions. Risk of bias across studies was moderate, and we found heterogeneity across results. Multi-component parenting and mental health interventions had a positive effect on child cognitive and social-emotional outcomes, but not on depressive symptoms in parents, suggesting that other factors might contribute to positive ECD outcomes. Interventions might lack adequate focus on mental health to make a discernible impact, highlighting a need for future studies to differentiate and assess contributions of parenting and mental health components to understand independent and collective effects on family outcomes. Canadian Institutes of Health Research.

Sex-specific Prediction of Cardiogenic Shock After Acute Coronary Syndromes: The SEX-SHOCK Score.

and aims: Cardiogenic shock (CS) remains the primary cause of in-hospital death after acute coronary syndromes (ACS), with its plateauing mortality rates approaching 50%. To test novel interventions, personalized risk prediction is essential. The ORBI (Observatoire Régional Breton sur l'Infarctus) score represents the first-of-its-kind risk score to predict in-hospital CS in ACS patients undergoing percutaneous coronary intervention (PCI). However, its sex-specific performance remains unknown, and refined risk prediction strategies are warranted. This multinational study included a total of 53 537 ACS patients without CS on admission undergoing PCI. Following sex-specific evaluation of ORBI, regression and machine-learning models were used for variable selection and risk prediction. By combining best-performing models with highest-ranked predictors, SEX-SHOCK was developed, and internally and externally validated. The ORBI score showed lower discriminative performance for the prediction of CS in females than males in Swiss (AUC [95% CI]: 0.78 [0.76-0.81] vs. 0.81 [0.79-0.83]; p=0.048) and French ACS patients (0.77 [0.74-0.81] vs. 0.84 [0.81-0.86]; p=0.002). The newly developed SEX-SHOCK score, now incorporating ST-segment elevation, creatinine, C-reactive protein, and left ventricular ejection fraction, outperformed ORBI in both sexes (females: 0.81 [0.78-0.83]; males: 0.83 [0.82-0.85]; p<0.001), which prevailed following internal and external validation in RICO (females: 0.82 [0.79-0.85]; males: 0.88 [0.86-0.89]; p<0.001) and SPUM-ACS (females: 0.83 [0.77-0.90], p=0.004; males: 0.83 [0.80-0.87], p=0.001). The ORBI score showed modest sex-specific performance. The novel SEX-SHOCK score provides superior performance in females and males across the entire spectrum of ACS, thus providing a basis for future interventional trials and contemporary ACS management.

50600 Inclusion of Race/Ethnicity Consideration in Scalp Seborrheic Dermatitis Shampoo Treatment Trials: A Systematic Review

50600 Inclusion of Race/Ethnicity Consideration in Scalp Seborrheic Dermatitis Shampoo Treatment Trials: A Systematic Review

Public perspective on potential treatment intervention harm in clinical trials-terminology and communication.

Randomised controlled trials (RCTs) are typically designed to determine beneficial intervention effects. In addition, an important aspect of every trial is to collect data on any potential harmful effects, with the aim of ensuring that the benefit-risk balance is appropriate. The language used by trialists to describe these potential harmful effects is inconsistent. In pharmacological trials, researchers collect adverse events; when a causal relationship is suspected adverse events are further classified as adverse reactions. Academic researchers have moved to collectively refer to these as harm outcomes; the pharmaceutical industry refer to these events as safety outcomes. In trials of complex interventions, phrases such as unintended consequences or effects are used. With the inconsistent use of terminology by researchers and the potential benefits to be gained from harmonising communications, we sought public opinion on terminology used to describe harmful effects and how these outcomes are communicated in the scientific literature, as well as in public facing material on medications. We held two in-person public involvement meetings with public partners, in London and Aberdeen in 2023. Both meetings followed a pre-specified format. We provided a background to the topic including the information researchers collect on potential harms in clinical trials and shared examples on how this information gets presented in practice. We then discussed public partners' perspectives on terminology used and communication of intervention harm in academic journals and in public facing materials. A summary of these discussions and the main topics raised by public partners are presented. Public partners endorsed the use of different terms for different situations, preferring the use of 'side-effect' across all contexts and reserving the use of 'harm' to indicate more severe events. Generally, public partners were happy with the type of information presented in public facing materials but discussions revealed that presentation of information on public NHS websites led to misconceptions about harm. This work provides a starting point on preferred terminology by patients and the public to describe potential harmful intervention effects. Whilst researchers have tried to seek agreement, public partners endorsed use of different terms for different situations. We highlight some key areas for improvement in public facing materials that are necessary to avoid miscommunication and incorrect perception of harm.

Comparison of Two Controlled Trials Designed to Reduce Aggressive Behavior in China

Objective: This report describes the outcomes of two controlled trials of a social information-processing intervention, the Let's Be Friends (LBF) program, which was designed to reduce aggressive behavior in primary school children in rural China. Method: A blocked clusters design with random sampling was used in each trial. Combining the two trials and adjusting for differences between the studies, we estimated outcomes across all treated ( n = 698) and control ( n = 710) group children; additionally, we compared Trial 1 treated children with Trial 2 treated children. Results: Across the combined studies, significant differences on children's social skills and behavior favored the LBF condition. However, the outcomes for Trial 2 demonstrated less robust behavioral effects, suggesting that the program was weakened by pandemic-related implementation and measurement challenges. Conclusion: The LBF appears to strengthen the social competence of children in rural China. However, conducting school-based interventions during environmental disruptions requires alternative delivery and measurement strategies.

Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial

IntroductionThere is a lack of evidence to support the effectiveness of prolonged β-blocker therapy after stabilisation of patients with acute myocardial infarction (AMI) without heart failure (HF) or left ventricular...

Socio-cognitive facilitators of ART-adherence among predominantly black sexual and gender minoritized persons living with HIV in Atlanta, Georgia: a latent profile analysis.

The Integrated Change Model describes several social and cognitive factors (e.g., health attitudes, social support, self-efficacy) that can affect medication adherence. Guided by this model, we sought to identify profiles of socio-cognitive facilitators of ART (antiretroviral therapy) adherence among diversely minoritized persons living with HIV enrolled in a behavioral intervention trial in Atlanta, Georgia (N = 477). To do this, we performed latent profile analysis on baseline responses to scales assessing 6 indicators of interest: HIV-care self-efficacy, social support, TasP (treatment-as-prevention) beliefs, trust in healthcare providers, perceived need for ART, and trust in ART. We regressed emergent profiles on internalized, enacted, and microaggressive HIV stigma and compared prospective 30-day ART adherence and several cross-sectional HIV outcomes across profiles. Mean age was 29 years; 83% of participants were non-Hispanic Black, 53% were gay/homosexual-identifying, and 12% were gender expansive. Three profiles emerged: "Constrained/Capable" (6%), featuring high self-efficacy but low-moderate provider trust, social support, TasP beliefs, ART trust, and ART need; "Conflicted" (13%), featuring high TasP beliefs, provider trust, and ART need but moderate self-efficacy, ART trust, and social support; and "Motivated" (81%), featuring high levels of all indicators. Greater internalized, enacted, and microaggressive stigma were positively associated with "Conflicted" relative to "Motivated" profile membership. ART-nonadherence, unsuppressed viral load, and viral load unawareness were more likely for the "Conflicted" relative to the "Motivated" profile. Personalized HIV care tailored to such profiles may improve ART adherence and related outcomes for minoritized persons living with HIV.

Qualitative evaluation of the SHARING Choices trial of primary care advance care planning for adults with and without dementia.

Primary care can be an important setting for communication and advance care planning (ACP), including for those with dementia and their families. The study objective was to explore experiences with a pragmatic trial of a communication and ACP intervention, SHARING Choices, in primary care for older adults with and without dementia. We conducted qualitative interviews using tailored semi-structured guides with three groups: ACP facilitators who conducted the intervention; clinicians, managers, and administrators from sites randomized to the intervention; and patients and families who met with ACP facilitators. We used thematic analysis to identify and synthesize emergent themes based on key Consolidated Framework for Implementation Research concepts and Proctor's Implementation Outcomes, triangulating the three groups' perspectives. We identified five key themes. For acceptability, perceptions of the intervention were mostly positive, although some components were not generally implemented. For adoption, respondents perceived that ACP facilitators mainly focused on conducting ACP, although facilitators often did not implement the ADRD and family engagement aspects with the ACP. For relational connections, ACP facilitator-practice and clinician communication and engagement were key to how the intervention was implemented. For adaptability, ACP facilitators and health systems adapted how the ACP facilitation component was implemented to local preferences and over time, given the pragmatic nature of the trial. And, for sustainability, ACP facilitators and clinicians/managers/facilitators were positive that the intervention should be continued but noted barriers to its sustainability. Patients and families generally did not recall the intervention. ACP facilitators and clinicians, managers, and administrators had positive perceptions of the ACP facilitator component of the intervention in this pragmatic trial with adaptation to local preferences. However, engaging those with dementia and families was more challenging in the implementation of this intervention.

ASO Visual Abstract: The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals-A Pilot Single-Arm Educational Intervention Trial.

ASO Visual Abstract: The Impact of a Breast Cancer Risk Assessment on the Decision for Gender-Affirming Chest Masculinization Surgery in Transgender and Gender-Diverse Individuals-A Pilot Single-Arm Educational Intervention Trial.

Quantitative Comparisons of Progressive Supranuclear Palsy Rating Scale Versions Using Item Response Theory.

Progressive supranuclear palsy (PSP) is a neurodegenerative, late-onset disease that is challenging in terms of assessment. The Progressive Supranuclear Palsy Rating Scale (PSPRS), a 28-item clinician-reported scale, is the most established clinical outcome assessment method. Recently, the U.S. Food and Drug Administration (FDA) has proposed a subscale of 10 items as an alternative to full PSPRS. To quantitatively evaluate and compare the properties of full PSPRS and the FDA subscale using item response theory. To develop a progression model of the disease and assess relative merits of study designs and analysis options. Data of 979 patients from four interventional trials and two registries were available for analysis. Our investigation was divided into: (1) estimating informativeness of the 28 items; (2) estimating disease progression; and (3) comparing the scales, trial designs, and analysis options with respect to power to detect a clinically relevant treatment effect. PSPRS item scores had a low pairwise correlation (r = 0.17 ± 0.14) and the items irritability, sleep difficulty, and postural tremor were uncorrelated with the other items. The FDA-selected items displayed higher correlation (r = 0.35 ± 0.14) and were the basis for a longitudinal item response model including disease progression. Trial simulations indicated that identification of a disease-modifying treatment effect required less than half the study size if the analysis was based on longitudinal item information compared with total scores at end-of-treatment. A longitudinal item response model based on the FDA-selected PSPRS items is a promising tool in evaluating treatments for PSP. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Response styles to positive affect during a positive psychology intervention for veterans with PTSD and moral injury: Preliminary results from a moral elevation intervention pilot trial.

Veterans with posttraumatic stress disorder (PTSD) or moral injury are at risk of maladaptive response styles to positive emotions, such as emotional numbing. A potential pathway to target problematic responses to positive affect is a positive psychology intervention that elicits moral elevation-feeling inspired after witnessing someone perform a virtuous act. This study aims to examine responses to positive affect in a pilot trial of a web-based moral elevation intervention titled, MOVED: Moral Elevation Online Intervention for Veterans Experiencing Distress Related to PTSD and Moral Injury. Method: Veterans who reported moral injury distress and probable PTSD were randomized into an intervention or control condition (n = 48). We examined repeated measures data during the trial and focused on three subscales of the Response to Positive Affect Questionnaire: rumination on positive mood and somatic experiences (emotion-focus), rumination on positive aspects of the self and pursuit of relevant goals (self-focus), and efforts to dampen positive moods (dampening). Three multilevel models were fitted with time and condition as predictors and subscale scores as outcomes. Qualitative data reported at intervention sessions was also reviewed and coded based on the three subscales. Veterans in the MOVED condition reported more positive rumination than the control condition for both emotion-focus (b = 2.70, p = .023) and self-focus styles (b = 2.90, p = .003). There was no group difference in the dampening style. Qualitative responses after elevation-eliciting exercises and session-based goals were most frequently coded as including emotion-focused positive rumination, followed by dampening, then self-focused rumination. These results provide preliminary evidence that a moral elevation intervention might contribute to positive responses to positive affect in a sample predisposed to emotional numbing. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Acceptance and commitment therapy versus progressive relaxation training for misophonia: Randomized controlled trial protocol, interventions, and audiological assessments

BackgroundMisophonia is a disorder characterized by an intense emotional reaction to specific sounds, often leading to significant distress and impairment in daily functioning. Acceptance and commitment therapy (ACT) is a promising psychotherapy for treating misophonia, but has only been previously tested in case studies. This paper presents a protocol for the first randomized controlled trial (RCT) assessing the efficacy and feasibility of ACT supplemented by audiological interventions for misophonia versus progressive relaxation training (PRT). MethodsThe outlined protocol is a RCT with 60 adults with misophonia. After undergoing a comprehensive psychological and audiological evaluation, participants were randomly assigned to ACT (n = 30) or PRT (n = 30). All participants completed clinician-administered and self-report assessments at baseline, post-intervention, 3-month follow-up, and 6-month follow-up. The primary outcome was misophonia severity and impairment measured via clinical interview. Secondary outcomes included disgust, anger, sensory sensitivities, well-being, distress, and psychological flexibility. DiscussionThis paper outlines the rationale of using ACT supplemented by audiological methods for misophonia with the novel therapeutic target of enhancing psychological flexibility. The results of this randomized controlled trial will help determine if ACT is an efficacious and acceptable treatment for misophonia. This trial will also help clarify active psychological mechanisms of misophonia, and assess whether this combination of psychological and audiological services can effectively help individuals with misophonia.

Discrimination of primary and chronic cytomegalovirus infection based on humoral immune profiles in pregnancy.

Most humans have been infected by Cytomegalovirus (CMV) by the time they reach forty years of age. Whereas most of these CMV infections are well controlled by the immune system, congenital infection can lead to serious health effects and death for the fetus and neonate. Most humans have been infected bywith cytomegalovirus (CMV) by the time they reach mid-life without clinical signs of disease. However, in settings in which the immune system is undeveloped or compromised, the virus is not adequately controlled, and consequently presents a major infectious cause of both congenital disease during pregnancy as well as opportunistic infection in children and adults. With clear evidence that risk to the fetus is lower during chronic maternal infection, and varies in association with gestational age at the time of primary maternal infection, further research on humoral immune responses to primary CMV infection during pregnancy is needed. Here, systems serology tools were applied to characterize antibody responses to CMV infection inamong pregnant and non-pregnant women experiencing either primary or chronic infection. Whereas strikingly different antibody profiles were observed depending on infection status, more limited differences were associated with pregnancy status. Beyond known differences in IgM responses that are used clinically for identification of primary infection, distinctions observed in IgA and FcγR- binding antibodiesy responses and among viral antigen specificities accurately predicted infection status in a cross-sectional cohort. Leveraging machine Machine learning, longitudinal samples were also was used to define an immunological clock of CMV infectionthe transition from primary to chronic states and predict time since primary infection with high accuracy. Humoral responses diverged over time in an antigen-specific manner, with IgG3 responses toward tegument decreasing over time as is typical of viral infections, while those directed to pentamer and glycoprotein B were lower during acute and greatest during chronic infection. In sum, this work provides new insights into the antibody response associated with CMV infection status in the context of pregnancy, revealing aspects of humoral immunity that have the potential to improve CMV diagnostics and to support clinical trials of interventions to reduce mother-to-fetus transmission of CMV. Not applicable Funding. CYMAF consortium and National Institutes of Health.

Steroids and Cross-Linking for Ulcer Treatment Trial II: Baseline Characteristics.

The Steroids and Cross-linking for Ulcer Treatment Trial is an NIH-funded international, randomized, double-masked, sham and placebo-controlled clinical trial to determine the benefit of adjunctive corneal cross-linking with riboflavin and/or topical difluprednate in addition to topical antibiotic drops for treatment of smear-positive bacterial ulcers. The purpose of this study was to explore the baseline characteristics for infection of patients enrolled, and the ocular comorbidities of patients screened for inclusion. Of the 2005 patients with smear-positive bacterial ulcers screened, 280 patients were enrolled. Descriptive statistics were used to summarize and characterize the data. Eligible patients in India had baseline factors associated with agricultural work (N = 132; 47%) and manual labor (N = 54; 19%), whereas patients in the United States were associated with contact lens wear (N = 11; 69%) (P <0.001). Nearly, 10% of patients with unilateral infectious keratitis are at risk of bilateral blindness because of preexisting visual disability in their other eye and thus ineligible for inclusion. India had higher rates of exclusionary factors for blindness in the other eye such as cataract (N = 48; 27%) and glaucoma (N = 24; 13) compared with the United States (N = 0; 0%) (P <0.001). While corneal ulceration is an important cause of disability in technologically advanced countries, it occurs more frequently in low and middle-income countries, and the implications on these populations should be considered. These baseline factors can be evaluated to address such health care disparities.

Targeted Treatments for Myasthenia Gravis in Children and Adolescents.

Myasthenia gravis (MG) is an antibody-mediated disorder of the neuromuscular junction affecting children and adults. MG is a treatable condition with most patients requiring immunosuppression for disease control and/or remission. Juvenile myasthenia gravis (JMG) is rare in comparison with adult-onset MG but given the same underlying pathophysiology, treatment strategies are similar to those in adults. Until recently, there were only a few randomised controlled trials (RCTs) for MG treatments in adults and none in children, and management strategies were primarily based on expert consensus. In addition, treatment options for refractory MG cases have been severely limited, resulting in poor long-term quality of life in such patients due to the significant disease burden. Recently, there have been several RCTs focussing on novel therapeutic strategies with potentially promising outcomes, suggesting a change in MG management over the coming years and access to more effective and faster-acting drugs for MG patients. This paper will review current and new MG treatments including efgartigimod, eculizumab, rozanolixizumab, ravulizumab, and zilucoplan, with a focus on juvenile myasthenia gravis.