Sex and Gender Differences in the Outcomes of Vaccination over the Life Course.

Both sex (i.e., biological differences) and gender (i.e., social or cultural influences) impact vaccine acceptance, responses, and outcomes. Clinical data illustrate that among children, young adults, and aged individuals, males and females differ in vaccine-induced immune responses, adverse events, and protection. Although males are more likely to receive vaccines, following vaccination, females typically develop higher antibody responses and report more adverse effects of vaccination than do males. Human, nonhuman animal, and in vitro studies reveal numerous immunological, genetic, hormonal, and environmental factors that differ between males and females and contribute to sex- and gender-specific vaccine responses and outcomes. Herein, we address the impact of sex and gender variables that should be considered in preclinical and clinical studies of vaccines.

Ablation of Transcription Factor IRF4 Promotes Transplant Acceptance by Driving Allogenic CD4+ T Cell Dysfunction.

CD4+ T cells orchestrate immune responses and destruction of allogeneic organ transplants, but how this process is regulated on a transcriptional level remains unclear. Here, we demonstrated that interferon regulatory factor 4 (IRF4) was a key transcriptional determinant controlling T cell responses during transplantation. IRF4 deletion in mice resulted in progressive establishment of CD4+ T cell dysfunction and long-term allograft survival. Mechanistically, IRF4 repressed PD-1, Helios, and other molecules associated with T cell dysfunction. In the absence of IRF4, chromatin accessibility and binding of Helios at PD-1 cis-regulatory elements were increased, resulting in enhanced PD-1 expression and CD4+ T cell dysfunction. The dysfunctional state of Irf4-deficient T cells was initially reversible by PD-1 ligand blockade, but it progressively developed into an irreversible state. Hence, IRF4 controls a core regulatory circuit of CD4+ T cell dysfunction, and targeting IRF4 represents a potential therapeutic strategy for achieving transplant acceptance.

COVID-19 precautionary behaviors and vaccine acceptance among older individuals: The role of close kin.

The family plays a central role in shaping health behaviors of its members through social control and support mechanisms. We investigate whether and to what extent close kin (i.e., partner and children) matter for older people in taking on precautionary behaviors (e.g., wearing a mask) and vaccination during the COVID-19 pandemic in Europe. Drawing on data from the Survey of Health, Ageing and Retirement in Europe (SHARE), we combine its Corona Surveys (June to September 2020 and June to August 2021) with pre-COVID information (October 2019 to March 2020). We find that having close kin (especially a partner) is associated with a higher probability of both adopting precautionary behaviors and accepting a COVID-19 vaccine. Results are robust to controlling for other potential drivers of precautionary behaviors and vaccine acceptance and to accounting for coresidence with kin. Our findings suggest that policymakers and practitioners may differently address kinless individuals when promoting public policy measures.

A cane toad (Rhinella marina) N-methyltransferase converts primary indolethylamines to tertiary psychedelic amines.

Psychedelic indolethylamines have emerged as potential medicines to treat several psychiatric pathologies. Natural sources of these compounds include 'magic mushrooms' (Psilocybe spp.), plants used to prepare ayahuasca, and toads. The skin and parotid glands of certain toads accumulate a variety of specialized metabolites including toxic guanidine alkaloids, lipophilic alkaloids, poisonous steroids, and hallucinogenic indolethylamines such as DMT, 5-methoxy-DMT, and bufotenin. The occurrence of psychedelics has contributed to the ceremonial use of toads, particularly among Mesoamerican peoples. Yet, the biosynthesis of psychedelic alkaloids has not been elucidated. Herein, we report a novel indolethylamine N-methyltransferase (RmNMT) from cane toad (Rhinella marina). The RmNMT sequence was used to identify a related NMT from the common toad, Bufo bufo. Close homologs from various frog species were inactive, suggesting a role for psychedelic indolethylamine biosynthesis in toads. Enzyme kinetic analyses and comparison with functionally similar enzymes showed that recombinant RmNMT was an effective catalyst and not product inhibited. The substrate promiscuity of RmNMT enabled the bioproduction of a variety of substituted indolethylamines at levels sufficient for purification, pharmacological screening, and metabolic stability assays. Since the therapeutic potential of psychedelics has been linked to activity at serotonergic receptors, we evaluated binding of derivatives at 5-HT1A and 5-HT2A receptors. Primary amines exhibited enhanced affinity at the 5-HT1A receptor compared with tertiary amines. With the exception of 6-substituted derivatives, N,N-dimethylation also protected against catabolism by liver microsomes.

The Perceived Usability of Virtual Visits Among Black Adults' Receiving Oncology Care: A Qualitative Analysis.

BACKGROUND: With the COVID-19 pandemic came rapid uptake in virtual oncology care. During this, sociodemographic inequities in access to virtual visits (VVs) have become apparent. To better understand these issues, we conducted a qualitative study to describe the perceived usability and acceptability of VVs among Black adults diagnosed with cancer. METHODS: Adults who self-identified as Black and had a diagnosis of prostate, multiple myeloma, or head and neck cancer were recruited from 2 academic medical centers, and their community affiliates to participate in a semi-structured interview, regardless of prior VV experience. A patient and family advisory board was formed to inform all components of the study. Interviews were conducted between September 2, 2021 and February 23, 2022. Transcripts were organized topically, and themes and subthemes were determined through iterative and interpretive immersion/crystallization cycles. RESULTS: Of the 49 adults interviewed, 29 (59%) had participated in at least one VV. Three overarching themes were derived: (1) VVs felt comfortable and convenient in the right contexts; (2) the technology required for VVs with video presented new challenges, which were often resolved by an audio-only telephone call; and (3) participants reported preferring in-person visits, citing concerns regarding gaps in nonverbal communication, trusting providers, and distractions during VV. CONCLUSION: While VVs were reported to be acceptable in specific circumstances, Black adults reported preferring in-person care, in part due to a perceived lack of interpersonal connectedness. Nonetheless, retaining reimbursement for audio-only options for VVs is essential to ensure equitable access for those with less technology savvy and/or limited device/internet capabilities.

Patient-reported quality of life and acceptance of the extravascular implantable cardioverter-defibrillator: Results from pivotal study.

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.

Sex-Differential and Non-specific Effects of Vaccines Over the Life Course.

Biological sex and age have profound effects on immune responses throughout the lifespan and impact vaccine acceptance, responses, and outcomes. Mounting evidence from epidemiological, clinical, and animal model studies show that males and females respond differentially to vaccination throughout the lifespan. Within age groups, females tend to produce greater vaccine-induced immune responses than males, with sex differences apparent across all age groups, but are most pronounced among reproductive aged individuals. Females report more adverse effects following vaccination than males. Females, especially among children under 5 years of age, also experience more non-specific effects of vaccination. Despite these known sex- and age-specific differences in vaccine-induced immune responses and outcomes, sex and age are often ignored in vaccine research. Herein, we review the known sex differences in the immunogenicity, effectiveness, reactogenicity, and non-specific effects of vaccination over the lifespan. Ways in which these data can be leveraged to improve vaccine research are described.

Neural mechanisms of acceptance-commitment therapy for obsessive-compulsive disorder: a resting-state and task-based fMRI study.

BACKGROUND: There is growing evidence for the use of acceptance-commitment therapy (ACT) for the treatment of obsessive-compulsive disorder (OCD). However, few fully implemented ACT have been conducted on the neural mechanisms underlying its effect on OCD. Thus, this study aimed to elucidate the neural correlates of ACT in patients with OCD using task-based and resting-state functional magnetic resonance imaging (fMRI). METHODS: Patients with OCD were randomly assigned to the ACT (n = 21) or the wait-list control group (n = 21). An 8-week group-format ACT program was provided to the ACT group. All participants underwent an fMRI scan and psychological measurements before and after 8 weeks. RESULTS: Patients with OCD showed significantly increased activation in the bilateral insula and superior temporal gyri (STG), induced by the thought-action fusion task after ACT intervention. Further psycho-physiological interaction analyses with these regions as seeds revealed that the left insular-left inferior frontal gyrus (IFG) connectivity was strengthened in the ACT group after treatment. Increased resting-state functional connectivity was also found in the posterior cingulate cortex (PCC), precuneus, and lingual gyrus after ACT intervention Most of these regions showed significant correlations with ACT process measures while only the right insula was correlated with the obsessive-compulsive symptom measure. CONCLUSIONS: These findings suggest that the therapeutic effect of ACT on OCD may involve the salience and interoception processes (i.e. insula), multisensory integration (i.e. STG), language (i.e. IFG), and self-referential processes (i.e. PCC and precuneus). These areas or their interactions could be important for understanding how ACT works psychologically.

Cognitive behavioral interventions for depression and anxiety in adults with neurological disorders: a systematic review and meta-analysis.

We examined the efficacy of cognitive and behavioral interventions for improving symptoms of depression and anxiety in adults with neurological disorders. A pre-registered systematic search of Cochrane Central Register of Controlled Trials, MEDLINE, PsycINFO, Embase, and Neurobite was performed from inception to May 2024. Randomized controlled trials (RCTs) which examined the efficacy of cognitive and behavioral interventions in treating depression and/or anxiety among adults with neurological disorders were included. Estimates were pooled using a random-effects meta-analysis. Subgroup analyses and meta-regression were performed on categorical and continuous moderators, respectively. Main outcomes were pre- and post-intervention depression and anxiety symptom scores, as reported using standardized measures. Fifty-four RCTs involving 5372 participants with 11 neurological disorders (including multiple sclerosis, epilepsy, stroke) were included. The overall effect of interventions yielded significant improvements in both depression (57 arms, Hedges' g = 0.45, 95% confidence interval [CI] 0.35-0.54) and anxiety symptoms (29 arms, g = 0.38, 95% CI 0.29-0.48), compared to controls. Efficacy was greater in studies which employed a minimum baseline symptom severity inclusion criterion for both outcomes, and greater in trials using inactive controls for depression only. There was also evidence of differential efficacy of interventions across the neurological disorder types and the outcome measure used. Risk of bias, intervention delivery mode, intervention tailoring for neurological disorders, sample size, and study year did not moderate effects. Cognitive and behavioral interventions yield small-to-moderate improvements in symptoms of both depression and anxiety in adults with a range of neurological disorders.

Public perception of folate-biofortified genetically modified lettuce varieties in Brazil.

Lettuce is one of the most widely consumed vegetables in the world, commonly eaten fresh in salads, sandwiches, wraps, and as a garnish in various dishes. Consequently, it is a very promising vehicle to deliver vitamins, such as folate (vitamin B9), to a specific population using biofortified varieties generated by conventional or molecular breeding. A new genetically modified lettuce was generated with increased folate content. However, some issues related to public perception regarding this technology should still be evaluated. The aim of this study was to analyze whether consumers are willing to accept a folate-biofortified GM lettuce that could become available to the Brazilian market. A questionnaire involving several issues regarding lettuce consumption was answered by 2,391 people from almost all Brazilian states. When informed that the folic acid biofortified lettuce is a transgenic plant, 46.1% of respondents stated that they would eat it and 30.5% stated that it would be a possibility. This study demonstrated that if there is any explanation regarding the advantage in relation to the use of biotechnology, like enrichment with folic acid, the number of people who accept it increases.

Testing the monitor and acceptance theory: the role of training-induced changes in monitoring- and acceptance-related capacities after attention-based, socio-emotional, or socio-cognitive mental training in reducing cortisol stress reactivity.

Mindfulness-based interventions have become a popular means to reduce stress. However, the specific mechanisms driving observed stress reduction remain understudied. The Monitor and Acceptance Theory suggests that the cultivation of monitoring and acceptance skills are necessary moderators of practice-induced stress reduction. In the context of the ReSource Project, a large healthy adult sample underwent three 3-month mental training modules targeting either attentional (Presence module), socio-affective (Affect module) or socio-cognitive skills (Perspective module). In the current study, the development of a range of inter-individual differences in mindfulness-, interoception- and compassion-related traits - which mapped to either monitoring or acceptance categories - was tracked. The relationship of these training-induced changes with cortisol stress reactivity after the three distinct 3-month training modules was explored. We found that stress sensitivity was particularly modulated by a differential adaptivity of one cultivated attentional capacity - Attention regulation - which predicted higher cortisol reactivity after mere attention training (Presence) but was associated with lower stress-induced cortisol release after additional socio-affective and socio-cognitive practice (Affect and Perspective). However, this effect did not survive multiple comparisons correction, and analyses were limited by the sample size available. We conclude that our study provides preliminary support of the Monitor and Acceptance Theory, lending weight to the advantage of primary attentional increases in order to fully harness the beneficial effects of socio-affective training, ultimately leading to stress reduction. Although training-induced increases in acceptance were not directly shown to contribute to lowering cortisol stress reactivity, the data suggest an additional benefit of socio-affective and socio-cognitive training that is not directly captured within the current analyses. Our study corroborates the importance of going beyond the training of attention monitoring to foster stress resilience, and highlights that mental training relies on the co-development of several interacting processes to successfully attenuate stress. Further exploring the overarching concept of acceptance in future research may prove beneficial to the theoretical framework of MAT, and in understanding the processes by which stress reduction occurs.

Maternal disapproval of friends in response to child conduct problems damages the peer status of pre- and early adolescents.

BACKGROUND: Herein, we consider the hypothesis that mothers harm peer relations when they respond to child conduct problems by expressing disapproval of friends, which exacerbates the behavior problems they were presumably attempting to deter. METHODS: A community sample of Lithuanian adolescents (292 boys and 270 girls, aged 9-14 years) completed surveys three times during an academic year. Classmate nominations indexed peer status (acceptance and rejection), self-reports described perceived maternal disapproval of friends, and peer nominations and self-reports separately gauged conduct problems. RESULTS: Over the course of a school year: (a) conduct problems were associated with subsequent increases in perceived maternal friend disapproval; (b) perceived maternal friend disapproval was associated with subsequent decreases in peer status; and (c) low peer status was associated with subsequent increases in conduct problems. Full longitudinal, random-intercept cross-lagged panel mediation models confirmed that mothers who disapproved of friends were sources of peer difficulties that culminated in conduct problems and intermediaries whose response to child conduct problems damaged peer relations. Findings were stronger for peer rejection than for peer acceptance, suggesting that peers actively dislike those with mothers who intervene in peer relationships. CONCLUSIONS: Maternal disapproval of friends in response to child conduct problems damages the child's standing among peers, which then exacerbates behavior problems. This consequential cascade underscores the need for parent education about the potential deleterious consequences of well-intentioned interference in peer relations. Practitioners should be prepared to offer constructive, alternative solutions when youth present behavior problems.

Psychological inflexibility as a predictor associated with insomnia.

Psychological flexibility has recently attracted the attention of researchers in the field of sleep disorders; therefore, in the study, psychological flexibility was evaluated as a predictor or factor related to the presence/severity of insomnia. We included 2218 individuals selected from the randomized-control trial for behavioural therapy for insomnia and cross-sectional studies, including 1797 individuals with insomnia and 421 controls without insomnia. All participants completed the DSM-5-based insomnia diagnosis interview, Insomnia Severity Index, Hospital Anxiety and Depression Scale, and Acceptance Action Questionnaire-II. Linear regression and multinomial logistic regression models were used. Sex, education, occupation, marital status, anxiety, depression and psychological inflexibility were possible predictors or factors associated with the severity of insomnia. Multivariate linear regression analysis demonstrated that sex (𝛽 = 0.88; t = 2.80; p = 0.005), depression (𝛽 = 0.41; t = 10.7; p < 0.001), anxiety (𝛽 = 0.58; t = 14.1; p < 0.001) and psychological inflexibility (𝛽 = 0.09; t = 5.07; p < 0.001) were predictors of insomnia. The results of the multinomial logistic regression demonstrate that, in comparison to the absence of insomnia, insomnia at all levels (mild, moderate and severe) was associated with sex, anxiety and depression. Psychological inflexibility was only associated with severe insomnia (odds ratio = 1.04). These findings are important from a public health perspective because behavioural strategies designed to treat insomnia with a focus on psychological flexibility are low-cost and may help improve sleep quality in adults with insomnia, which also influences mental health.

Factors Influencing Knowledge and Acceptance of Nonavalent Human Papillomavirus Vaccine Among University Population in Southern China: A Cross-Sectional Study.

BACKGROUND: Vaccine hesitancy among young Chinese remains a challenge, contributing to low vaccination rates for the nonavalent Human Papillomavirus (HPV) vaccine. This study evaluated the knowledge and acceptance of this vaccine among students at a southern Chinese university and identified factors influencing these outcomes. METHODS: This cross-sectional, anonymous questionnaire survey was conducted from April to November 2023 at a multi-campus university in southern China. The questionnaire was comprised of three sections: the first collected demographic data; the second evaluated students' knowledge of the nonavalent HPV vaccine on a scale from 0 to 15, with cut-off points at 5 and 10 delineating low, medium, and high knowledge levels, respectively; the third section assessed vaccine acceptance on a scale from 8 to 40, using scores above the 50th percentile as the benchmark for positive acceptance. RESULTS: Among the participants, 18% demonstrated low-level, 40.20% medium-level, and 41.70% high-level knowledge of the nonavalent HPV vaccine. Notably, 71.95% of respondents showed positive acceptance, whereas 28.05% expressed negative acceptance. Male students and those with lower economic conditions (monthly living expenses below 1000 RMB, P = 0.004; 1000-1499 RMB, P = 0.012) exhibited lower knowledge levels. As for acceptance, female students and those with higher monthly living expenses (1000-1499 RMB, P = 0.007; 1500-1999 RMB, P = 0.002; over 2000 RMB, P = 0.002) demonstrated greater vaccine acceptance. A positive correlation was noted between the level of knowledge and vaccine acceptance (rs = 0.256, P < 0.001). CONCLUSIONS: Gender and economic status are significantly associated with nonavalent HPV vaccine knowledge and acceptance among university students. These findings highlight the potential impact of targeted educational initiatives, especially for economically disadvantaged male students, in enhancing vaccine uptake rates.

Many young people in China are hesitant to get the nine - valent HPV vaccine, which protects against certain types of viruses that can cause cancer. This study looked at how much students at a university in southern China know about the nine - valent HPV vaccine and whether they are willing to get vaccinated. We asked students to fill out a survey between April and November 2023 to gather this information. The survey showed that knowledge about this vaccine varied: about 18% of the students knew very little, 40% had a moderate understanding, and roughly 42% knew a lot about this vaccine. Interestingly, more than 70% of the students were open to getting the vaccine, but about 28% were not. We found that male students and those with less money generally knew less about the vaccine and were more likely to not accept it. There was also a clear link between how much students knew about the vaccine and their willingness to get vaccinated. This suggests that teaching students more about this vaccine, especially boys and those from poorer backgrounds, could encourage more of them to get vaccinated. This is important because increasing vaccine rates can help prevent diseases spread by the virus.

Advancements in food science for Phenylketonuria (PKU) management: a comprehensive review.

This review systematically explores the pivotal role of food science and technology as a support for Phenylketonuria (PKU) dietary management. It delves into the genetic and metabolic underpinnings of PKU, highlighting the crucial need for stringent dietary regulation to manage phenylalanine levels and mitigate neurological complications. Through bibliometric analysis and current product evaluations, it identifies trends in PKU food research, emphasizing recent innovations in food formulations such as glycomacropeptide (GMP) supplements and higher appealing low-phenylalanine food products. Furthermore, it accentuates the sensory and consumer aspects of PKU dietary solutions, underscoring the importance of palatability for adherence. Notably, the review introduces 3D food printing as an emerging technology for creating personalized, nutrient-optimized, and sensory-appealing foods for PKU patients, offering a new horizon in dietary management. This comprehensive assessment underscores the dynamic interplay between nutritional science, food technology, and sensory evaluation in improving the quality of life for individuals with PKU.

Community acceptance of a novel malaria intervention, Attractive Targeted Sugar Baits, in the Zambia phase III trial.

BACKGROUND: Community acceptance is an important criterion to assess in community trials, particularly for new tools that require high coverage and use by a target population. Installed on exterior walls of household structures, the attractive targeted sugar bait (ATSB) is a new vector control tool designed to attract and kill mosquitoes. ATSBs were evaluated in Western Zambia during a two-year cluster randomized controlled trial to assess the efficacy of ATSBs in reducing malaria transmission. Community acceptance of ATSBs was critical for successful trial implementation. METHODS: A community engagement strategy outlined activities and key messages to promote acceptance. Annual cross-sectional surveys, conducted during the peak transmission period, assessed households for presence of ATSBs as well as perceived benefits, concerns, and willingness to use ATSBs. Sixteen focus group discussions and 16 in-depth interviews, conducted at the end of each ATSB station deployment period, obtained a range of perceptions and household experiences with ATSB stations, as well as ITN use in the context of ATSB deployment. RESULTS: Methods used during the study to promote acceptance and continued use of ATSBs were effective in achieving greater than 90% coverage, a high (greater than 70%) level of perceived benefits, and fewer than 10% of households reporting safety concerns. Common facilitators of acceptance included the desire for protection against malaria and reduction of mosquitoes, trust in health initiatives, and understanding of the product. Common barriers to acceptance included misconceptions of product impact on mosquitoes, continued cases of malaria, association with satanism, and damage to household structures. DISCUSSION: Future use of the ATSB intervention will likely require activities that foster community acceptance before, during, and after the intervention is introduced. Additional research may be needed to understand the impact of different levels of community engagement on ATSB station coverage, ATSB station perception, and ITN use. CONCLUSION: There was high acceptance of ATSB stations during the trial in Western Zambia. Continuous and intense community engagement efforts contributed to sustained ATSB coverage and trust in the product. Acceptance of ATSBs during programmatic delivery requires further research.

Examining the impact of androgen deprivation therapy, masculine self-esteem, and psychological flexibility on distress and quality of life in men with prostate cancer.

OBJECTIVE: Studies suggest that androgen deprivation therapy (ADT) exacerbates psychological and quality of life (QoL) issues associated with prostate cancer (PCa). However, quantitative research examining underlying psychosocial mechanisms for this is limited. We examined the association of PCa symptoms with distress and QoL in ADT-treated and ADT-naïve patients, and the influence of masculine self-esteem and psychological flexibility (PF) on these relationships. METHODS: Secondary analysis of a quantitative, cross-sectional survey of 286 PCa patients. Independent samples t-tests, moderation, and conditional process analysis were used to assess relationships between predictor, mediator, moderator, and outcome variables. RESULTS: ADT was associated with greater PCa symptomology, lower masculine self-esteem, and lower QoL. Moderation analysis showed that ADT potentiated adverse impacts of PCa symptomology on distress and QoL. High PF attenuated these relationships, though less so for ADT-treated participants. Conditional process analysis showed that masculine self-esteem mediated the predictive effect of symptoms on distress across treatments. However, ADT did not moderate this indirect effect, nor was moderation conditional on PF. CONCLUSION: PF appears to: (1) attenuate psychological distress in ADT patients; and (2) improve distress, QoL, and masculine self-esteem in ADT-naïve patients. Interventions targeting PF may thus be a viable adjunct to established approaches. However, their effects may be comparatively limited in ADT patients, who may benefit from more intensive and tailored treatment.

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. METHODS: This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. RESULTS: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). CONCLUSIONS: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. TRIAL REGISTRATION: ISRCTN12027752.

A randomized clinical trial: Efficacy of group-based acceptance and commitment therapy program for breast cancer patients with high fear of progression.

BACKGROUND: Fear of progression (FOP) is a common and significant concern among cancer patients, encompassing worries about cancer progression during active treatment. Elevated levels of FOP can be dysfunctional. This study aims to assess the efficacy of an Acceptance and Commitment Therapy (ACT)-based intervention on FOP, anxiety sensitivity (AS), and quality of life (QOL) in breast cancer patients. METHODS: A clinical trial was conducted involving 80 stage I-III active-treatment breast cancer patients with a score greater than 34 on the Fear of Progression Questionnaire-Short Form scale. These patients were randomly assigned in a 1:1 ratio to either an intervention group, which received weekly 70-min sessions of 5-ACT-bsed group-therapy, or a control group that received usual treatment. Variables including FOP, AS, QOL, and ACT-related factors were assessed using ASQ, QLQ-C30, Cognitive Fusion Questionnaire, and Acceptance and Action Questionnaire-II at three time points: baseline, post-intervention, and 3-month follow-up. The efficacy of the intervention was evaluated using mixed model analysis across all time-points. RESULTS: The fidelity and acceptability of the ACT-based manual were confirmed using significant methods. A significant reduction in FOP was observed only in the ACT group at post-intervention (P-valueACT < 0.001; Cohen dACT = 1.099). Furthermore, the ACT group demonstrated a more significant reduction in FOP at follow-up. Furthermore, all secondary and ACT-related variables, except for the physical symptoms subscale, showed significant improvement in the ACT group compared to the control group. CONCLUSIONS: Our ACT-based manual showed promise for reducing FOP, AS, and improving QOL, and ACT-related variables in breast cancer patients 3 months following the intervention.

Black Young Adult Superwomen in the Face of Gendered Racial Microaggressions: Contextualizing Challenges With Acceptance and Avoidance and Emotional Eating.

BACKGROUND: Black young adult women (ages 18-35) are at disproportionate risk for obesity and emotional eating. Emotional eating interventions target psychological flexibility, such as reducing experiential avoidance and increasing acceptance of food-related thoughts. Yet Black women face gendered racism, and some endorse roles that reduce psychological flexibility, such as the superwoman schema role. Culturally centered stress and coping has often been overlooked, leading to an incomplete understanding of processes that engender emotional eating and the implications for appropriate and effective interventions for Black young adult women. PURPOSE: We investigated direct and indirect pathways of associations between stress from gendered racial microaggressions to emotional eating through the endorsement of superwoman schema and two aspects of psychological flexibility. METHODS: Black young adult women (N = 504; Mage = 24.72; 75.2% African American; 98.4% cisgender) participated in an online survey wherein they reported demographics, stress from gendered racial microaggressions, superwoman schema, experiential avoidance, acceptance of food-related thoughts, and emotional eating. Path analysis was conducted to examine direct and indirect effects. RESULTS: Results provided evidence for indirect associations between more stress from gendered racial microaggressions and more emotional eating. More stress was associated with greater endorsement of the superwoman schema which was associated with more experiential avoidance and less acceptance of food-related thoughts, which were each associated with more emotional eating. CONCLUSIONS: Endorsement of superwoman schema and concomitant avoidance and less acceptance may be one way that gendered racial stress propels emotional eating. Future research could test intervention components that disrupt this path.

Emotional eating is eating in order to alleviate negative emotions, like those from stress. Black young adult women face particular forms of stress from being mistreated at the intersection of their race and gender. This research was needed to better understand processes that engender emotional eating for Black young adult women so that appropriate and effective interventions can be developed for this group. In this correlational study, Black young adult women (ages 18­35) completed an online survey wherein they answered questions about their experiences, thoughts, and behaviors. The study results indicated that stress from mistreatment due to being a Black woman was associated with endorsing a need to be strong. This need to be strong was associated with avoiding experiences that may lead to negative emotional states and being less accepting of distressing thoughts about food. More avoidance and less acceptance were each associated with more emotional eating. Therefore, if emotional eating or obesity-related interventions already target acceptance and avoidance, but do not reference or contextualize them for Black young adult women­particularly in terms of stress from mistreatment as a Black woman and the need to be strong­such interventions may be less effective.