Arriba por la Vida Estudio: a randomized controlled trial promoting standing behavior to reduce sitting time among postmenopausal Latinas.

Postmenopausal Hispanic/Latina (N = 254) women with a body mass index (BMI) ≥ 25 kg/m2 were randomized to an intervention to reduce sitting time or a comparison condition for 12 weeks. The standing intervention group received three in-person health-counseling sessions, one home visit, and up to eight motivational interviewing calls. The heart healthy lifestyle comparison group (C) received an equal number of contact hours to discuss healthy aging. The primary outcome was 12-week change in sitting time measured via thigh-worn activPAL. Group differences in outcomes were analyzed using linear mixed-effects models. Participants had a mean age of 65 (6.5) years, preferred Spanish language (89%), BMI of 32.4 (4.8) kg/m2, and sat for an average of 540 (86) minutes/day. Significant between-group differences were observed in reductions of sitting time across the 12-week period [Mdifference (SE): C - 7.5 (9.1), SI - 71.0 (9.8), p < 0.01]. Results demonstrate that coaching models to reduce sitting are feasible and effective.

Effects of intensity, frequency, and time window of exercise on sleep quality among community-dwelling adults aged 65-86 years.

BACKGROUND: Although the effects of exercise training (ET) on sleep problem have been reported, the effects according to the components of exercise, including intensity, frequency, and time window, are unknown. Thus, in this study, we aimed to assess the effects of ET on sleep quality in community-dwelling older adults with sleep problems. METHODS: We evaluated individuals aged ≥65 years whose Pittsburgh sleep quality index was >5 points at baseline. The participants were allocated to either the control group or the ET group and underwent interval walking training (IWT) for 5 months. Information regarding intensity, frequency, and time window of ET were obtained using a waist-worn accelerometer. RESULTS: Overall, 63 participants (24 men [mean ± standard deviation age: 75.1 ± 4.6 years] and 39 women [74.7 ± 5.2 years]) and 65 participants (24 men [75.2 ± 4.0 years] and 41 women [73.6 ± 4.2 years]) were included in the ET and control groups, respectively. The change in Pittsburgh sleep quality index was not significantly different between the two groups for both sexes. In the ET group, women who exercised 3-8 h before bedtime, men who did ET > 8 h before bedtime and more than 1 h after waking up, and men who did ET ≥ 5.05 days/week experienced significant improvements compared to the baseline. CONCLUSIONS: IWT does not significantly improve sleep quality. To obtain improvements in sleep quality, it might be necessary to consider the time window of performing ET for both sexes and ET frequency for men.

The Safe Home Care Intervention Study: Implementation Methods and Effectiveness Evaluation.

Home care (HC) aides experience numerous safety hazards in clients' homes; many hazards also put clients at risk. We hypothesized that safety coaching led by nurse managers (NMs) during their initial HC needs assessment could prompt clients to improve safety conditions in their homes. Following a 2-arm proof-of-concept intervention study design, intervention NMs used motivational interviewing (MI), facilitated by a safety handbook and video, to coach clients on home safety improvements. Control arm NMs performed intake assessments with no changes to usual practices. Intervention effectiveness was assessed by NMs and aides. Three HC agencies and two elder services contributed 35 intervention and 23 control homes. NMs coached 97% of clients and reported that 94% were engaged; 63% implemented improvements. NMs' and aides' assessments were consistent; homes with clients reported by NMs as resistant to safety changes had higher aides' hazard scores. Client coaching can be effective for improving HC safety.

Interventions to improve ethical decision-making skills in nursing students: A systematic review.

BACKGROUND: Interventions to improve ethical decision-making are available in nursing education. Evidence of its effectiveness is essential. OBJECTIVE: This review examined the effectiveness of interventions to improve nursing students' ethical decision-making skills. METHODS: A structured search was performed in Google Scholar, Web of Science, Science Direct, Pubmed, Scopus, Cochrane Library, Elsevier, CINAHL EBSCO, and ULAKBIM. The Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instruments (JBI-MAStARI) was used to assess the quality of studies. ETHICAL CONSIDERATIONS: Ethical approval was not required for this systematic review. FINDINGS: The final review was composed of six studies of published between January 2013 and 2023. Nine different teaching methods applied to students. Although the importance of ethical decision-making skills in solving ethical problems that nurses may encounter at any time is known, it is thought that there is a lack of data in the literature in the last 10 years. The last 10 years were chosen as this aims to provide a review based on the most current, relevant and quality information. The review indicated that all of the teaching methods improved ethical decision-making. CONCLUSION: Different teaching methods can be used in the nursing education curriculum to meet the learning needs of nursing students in ethical decision-making.

Carvacrol prophylaxis improves clinical outcome and dampens apoptotic and pro-inflammatory immune responses upon Campylobacter jejuni infection of human microbiota-associated IL-10-/- mice.

Incidence rates of human Campylobacter jejuni infections are progressively increasing globally. Since the risk for the development of post-infectious autoimmune diseases correlates with the severity of the preceding enteritis and campylobacteriosis treatment usually involves symptomatic measures, it is desirable to apply antibiotic-independent compounds to treat or even prevent disease. Given its health-promoting including anti-inflammatory properties carvacrol constitutes a promising candidate. This prompted us to test the disease-alleviating including immune-modulatory effects of carvacrol prophylaxis in acute murine campylobacteriosis. Therefore, human gut microbiota-associated IL-10-/- mice were orally challenged with synthetic carvacrol starting a week before C. jejuni infection and followed up until day 6 post-infection. Whereas carvacrol prophylaxis did neither affect gastrointestinal pathogen loads, nor the human commensal gut microbiota composition, it improved the clinical outcome of mice, attenuated colonic epithelial cell apoptosis, and dampened pro-inflammatory immune responses not only in the intestinal tract but also in extra-intestinal organs including the liver and the spleen. In conclusion, our preclinical placebo-controlled intervention study provides convincing evidence that oral carvacrol pretreatment constitutes a promising option to mitigate acute campylobacteriosis and in turn, to reduce the risk for post-infectious complications.

Menthol Pretreatment Alleviates Campylobacter jejuni-Induced Enterocolitis in Human Gut Microbiota-Associated IL-10-/- Mice.

Human Campylobacter jejuni infections are of worldwide importance and represent the most commonly reported bacterial enteritis cases in middle- and high-income countries. Since antibiotics are usually not indicated and the severity of campylobacteriosis is directly linked to the risk of developing post-infectious complications, non-toxic antibiotic-independent treatment approaches are highly desirable. Given its health-promoting properties, including anti-microbial and anti-inflammatory activities, we tested the disease-alleviating effects of oral menthol in murine campylobacteriosis. Therefore, human gut microbiota-associated IL-10-/- mice were orally subjected to synthetic menthol starting a week before C. jejuni infection and followed up until day 6 post-infection. Whereas menthol pretreatment did not improve campylobacteriosis symptoms, it resulted in reduced colonic C. jejuni numbers and alleviated both macroscopic and microscopic aspects of C. jejuni infection in pretreated mice vs. controls. Menthol pretreatment dampened the recruitment of macrophages, monocytes, and T lymphocytes to colonic sites of infection, which was accompanied by mitigated intestinal nitric oxide secretion. Furthermore, menthol pretreatment had only marginal effects on the human fecal gut microbiota composition during the C. jejuni infection. In conclusion, the results of this preclinical placebo-controlled intervention study provide evidence that menthol application constitutes a promising way to tackle acute campylobacteriosis, thereby reducing the risk for post-infectious complications.

Effectiveness of Sports Nutrition Education Based on Self-Determination Theory for Male University Rowing Athletes: A Randomized Controlled Trial.

To resolve problems in the dietary life of university athletes, education is essential to enable athletes to change their own dietary behavior. The purpose of this research was to verify the effectiveness of sports nutrition education based on self-determination theory (SDT). The participants were 36 male university rowers. A stratified randomized comparison test was conducted by student year (SDT group and control group). Sports nutrition education was held three times, via an Internet conferencing system. Furthermore, group work over social media was used for the SDT group. Four evaluations were carried out based on anthropometric measurements, a brief self-administered diet history questionnaire (BDHQ), sports nutrition knowledge test (SNK), and treatment self-regulation questionnaire (TSRQ). The results showed no differences between the two groups. However, for the intragroup factor, "Protein", a significant difference was evident in the self-determination theory group (50.0 ± 28.5, 78.6 ± 28.1, 81.0 ± 21.5, p < 0.000, units: %) and improved knowledge (p = 0.002, p = 0.002). And for the BDHQ, the self-determination theory group also showed significant differences and increased their intake of green and yellow vegetables, fruits, and dairy products (159.1 ± 74.2-126.7 ± 70.6, p = 0.009, 306.0 ± 196.2-195.2 ± 146.1, p = 0.020, 257.0 ± 147.0-183.3 ± 167.9, p = 0.040, units: g). In conclusion, sports nutrition education based on SDT improved dietary knowledge and increased food requirements for athletes.

Measles vaccination coverage and immunization status of nurses: An interventional study in Türkiye.

INTRODUCTION: Healthcare workers are more likely to contract measles than the general population. Our study aimed to assess measles vaccination and immunization levels among nurses, examine the influencing factors and implement an intervention program to increase immunization coverage. MATERIALS AND METHODS: Our study was conducted in a university hospital in Türkiye. The study included 1012 nurses. It was an intervention study, continued between 01/11/2021 and 30/10/2023. Measles IgG and vaccination status of the participants were evaluated. Participants with negative measles IgG results who had not been vaccinated against measles or received a single dose of the vaccine were invited to the outpatient clinic to receive two doses. Participants who had received two doses of the measles vaccine and had negative measles IgG results were invited to the outpatient clinic for one dose of the measles vaccine. Nine hundred seventy-eight people participated in our study. The access frequency was 96.6%. RESULTS: Among the participants aged 21-30, 68.4 % were Measles IgG (+). Measles IgG (+) prevalence was higher in women than men (85.3 % vs. 61.0 %). The department with the lowest measles IgG positivity was intensive care (75.8 %). Measles IgG (+) prevalence became higher as the duration of employment increased. The measles seropositivity in total population rose from 83.1 % before the intervention to 94.3 % after, to 91.8 % in the 21-30 age group, and to 90.2 % in male. Sixteen people had never received measles vaccination. Of the 37 participants who had previously received two doses of measles vaccine, 22 received a single dose and after the intervention 16 (72.7 %) were positive. Only 1 person was found to have vaccine refusal during the intervention. CONCLUSION: Expanding the immunization scope in hospitals by screening for measles antibodies among healthcare personnel and vaccinating those who are seronegative can be considered an effective public health strategy.

Coaching Home Care Clients to Prepare Their Homes for Safe Care Visits: A Mixed-Methods Study to Evaluate a Nurse-Led Educational Intervention Process.

Assuring home care (HC) workers' safety is challenging because the work environment is a private home. This paper presents the process evaluation for a proof-of-concept safety intervention study to assess whether nurse-led safety coaching, using motivational interviewing and a safety handbook, could enable HC clients to improve safety in their homes. The process evaluation objectives were to (i) document the intervention's implementation progress and (ii) assess the intervention's dose delivery, dose reception, and fidelity. Five agencies employing liaisons (n = 5) and nurse managers (NMs, n = 8) implemented this study's intervention and control arms. NMs assigned to the intervention arm (n = 6) coached 34 clients. Process evaluation metrics were assessed with mixed-methods data from (i) surveys completed by NMs during the intervention, (ii) postintervention audio-recorded and transcribed interviews (n = 6) with NMs and liaisons, and (iii) study progress tracking tools. The delivered dose efficiency was 85%, measured by the distribution of safety handbook copies to clients. About 94% of clients (n = 32) were considered "engaged" or "maybe engaged" during the safety coaching. Most coached clients (n = 30) were reachable for follow-up by NMs to assess intervention progress. Despite challenges, the intervention was implemented with good fidelity. Safety coaching can be applied in many HC contexts in larger populations.

Using a Novel Gameplay Intervention to Target Intrusive Memories After Work-Related Trauma: Iterative Qualitative Analysis of Intensive Care Unit Staff Experiences.

BACKGROUND: Many intensive care unit (ICU) staff experience intrusive memories following work-related traumatic events, which can lead to long-term mental health outcomes and impact work functioning. There is a need for interventions that target intrusive memories in this population; however, factors such as mental health stigma and difficulty in fitting interventions into busy schedules can pose barriers. The Brief Gameplay Intervention For National Health Service Intensive Care Unit Staff Affected By COVID-19 Trauma (GAINS) study tested a brief, digital imagery-competing task intervention (including computer gameplay) with the aim of reducing the recurrence of intrusive memories, which holds promise for overcoming some of these barriers. OBJECTIVE: This substudy aims to explore barriers and facilitators to the uptake and practical use of the intervention by ICU staff, along with its acceptability, and iteratively explore the impact of intervention optimizations to further refine the intervention. METHODS: The GAINS study is a randomized controlled trial comparing access to a brief digital imagery-competing task intervention for 4 weeks with usual care followed by delayed access to the intervention. The participants were ICU staff who worked during the COVID-19 pandemic and experienced intrusive memories. All participants were sent a questionnaire at 4 weeks to gather data about intervention acceptability. Nested within the randomized controlled trial, a subset of 16 participants was interviewed, and data were analyzed using thematic analysis drawing from a framework approach. RESULTS: Both quantitative and qualitative data indicated high acceptability of the intervention. Intervention use data show that, on average, staff were able to target approximately 73% (3.64/4.88) of their intrusive memories and engaged with the Tetris component for the full 20 minutes per session. Overall, on the acceptability questionnaire, staff found the intervention easy to use, helpful, and highly acceptable. The interviews generated four themes: approach to the intervention, positives of the intervention, negatives of the intervention, and improvements and optimizations. Findings highlighted barriers that ICU staff experienced: stigma, feeling weak for seeking help, not wanting colleagues to know they were struggling, and skepticism. However, they provided suggestions on how barriers could be overcome and discussed the advantages of the intervention when compared with other treatments. Although participants described many positive aspects of the intervention, such as being easy to use, enjoyable, and leading to a reduction in the frequency or intensity of intrusive memories, they also raised practical issues for implementation. CONCLUSIONS: The intervention has the potential to overcome stigma and reduce the frequency of intrusive memories after traumatic events among ICU staff. Further refinement is needed to improve the adoption and reach of this intervention. A limitation is that we could not interview the National Health Service staff who were unable or unwilling to take part in the trial.

Prophylactic Oral Application of Activated Charcoal Mitigates Acute Campylobacteriosis in Human Gut Microbiota-Associated IL-10-/- Mice.

The incidence of human Campylobacter jejuni infections is increasing worldwide. It is highly desirable to prevent campylobacteriosis in individuals at risk for severe disease with antibiotics-independent non-toxic compounds. Activated charcoal (AC) has long been used as an anti-diarrheal remedy. Here, we tested the disease-mitigating effects of oral AC versus placebo in human gut microbiota-associated (hma) IL-10-/- mice starting a week prior to C. jejuni infection. On day 6 post-infection, the gastrointestinal C. jejuni loads were comparable in both infected cohorts, whereas campylobacteriosis symptoms such as wasting and bloody diarrhea were mitigated upon AC prophylaxis. Furthermore, AC application resulted in less pronounced C. jejuni-induced colonic epithelial cell apoptosis and in dampened innate and adaptive immune cell responses in the colon that were accompanied by basal concentrations of pro-inflammatory mediators including IL-6, TNF-α, IFN-γ, and nitric oxide measured in colonic explants from AC treated mice on day 6 post-infection. Furthermore, C. jejuni infection resulted in distinct fecal microbiota shift towards higher enterobacterial numbers and lower loads of obligate anaerobic species in hma mice that were AC-independent. In conclusion, our pre-clinical placebo-controlled intervention study provides evidence that prophylactic oral AC application mitigates acute murine campylobacteriosis.

Oral treatment of human gut microbiota associated IL-10-/- mice suffering from acute campylobacteriosis with carvacrol, deferoxamine, deoxycholic acid, and 2-fucosyl-lactose.

Food-borne Campylobacter jejuni infections constitute serious threats to human health worldwide. Since antibiotic treatment is usually not indicated in infected immune-competent patients, antibiotic-independent treatment approaches are needed to tackle campylobacteriosis. To address this, we orally applied carvacrol, deferoxamine, deoxycholate, and 2-fucosyl-lactose either alone or all in combination to human microbiota-associated IL-10-/- mice from day 2 until day 6 following oral C. jejuni infection. Neither treatment regimen affected C. jejuni loads in the colon, whereas carvacrol lowered the pathogen numbers in the ileum on day 6 post-infection (p.i.). The carvacrol and combination treatment regimens resulted in alleviated diarrheal symptoms, less distinct histopathological and apoptotic epithelial cell responses in the colon, as well as diminished numbers of colonic neutrophils and T lymphocytes on day 6 p.i., whereas the latter cells were also decreased upon deferoxamine, deoxycholate, or 2-fucosyl-lactose application. Remarkably, the carvacrol, deferoxamine, and combination treatment regimens dampened ex-vivo IFN-γ secretion in the colon, the kidneys, and even in the serum to basal concentrations on day 6 p.i. In conclusion, carvacrol alone and its combination with deferoxamine, deoxycholate, and 2-fucosyl-lactose constitute promising antibiotics-independent treatment options to fight acute campylobacteriosis.

A hybrid effectiveness-implementation trial of application-based tiered care (Mom's Good Mood) in treating perinatal anxiety within a primary health care system in China.

INTRODUCTION: Perinatal anxiety (PNA) is a major public health concern. METHODS: A hybrid effectiveness-implementation trial was conducted in two antenatal clinics in Hefei, China, to assess the effectiveness and cost-effectiveness of application-based tiered care (Mom's Good Mood, MGM) in treating PNA and to understand how well it fits into routine practices. Pregnant women who scored at least 5 points on the 7-Item Generalised Anxiety Disorder Scale (GAD-7) scale were successively assigned to the control group or the intervention group, which were given the usual care and MGM on usual care, respectively. At 6 months post partum, anxiety, depression and life satisfaction were assessed. Intention-to-treat analysis and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework were adopted. RESULTS: A total of 214 women were assigned to the control group and 341 to the intervention group. The mean changes in GAD-7 scores (Least-squares means, LSM, -1.42, 95% CI -2.18 to -0.66) and the risk of anxiety (adjusted odds ratio, aOR 0.30, 95% CI 0.18 to 0.51) were decreased, and the anxiety remission rate (aOR 2.72, 95% CI 1.69 to 4.40) were improved in the intervention group. Similar findings were observed regarding the change in Edinburgh Postnatal Depression Scale scores (LS -1.92, 95% CI -2.85 to -0.99), depression remission rate (aOR 2.24, 95% CI 1.39 to 3.63) and the risk of depression (aOR 0.57, 95% CI 0.33 to 0.98). MGM only costs ¥1.88 (US$0.27) per pregnant woman to boost the postpartum anxiety remission rate by 1% and was revealed to have a high reach rate of 78.3%, an adoption rate of 51.3%-80.8%. CONCLUSION: MGM is a cost-effective and accessible tool in coping with PNA. TRIAL REGISTRATION NUMBER: ChiCTR2100053419.

Effects of Consuming Beverages Sweetened with Fructose, Glucose, High-Fructose Corn Syrup, Sucrose, or Aspartame on OGTT-Derived Indices of Insulin Sensitivity in Young Adults.

(1) Background: Clinical results on the effects of excess sugar consumption on insulin sensitivity are conflicting, possibly due to differences in sugar type and the insulin sensitivity index (ISI) assessed. Therefore, we compared the effects of consuming four different sugars on insulin sensitivity indices derived from oral glucose tolerance tests (OGTT). (2) Methods: Young adults consumed fructose-, glucose-, high-fructose corn syrup (HFCS)-, sucrose-, or aspartame-sweetened beverages (SB) for 2 weeks. Participants underwent OGTT before and at the end of the intervention. Fasting glucose and insulin, Homeostatic Model Assessment-Insulin Resistance (HOMA-IR), glucose and insulin area under the curve, Surrogate Hepatic Insulin Resistance Index, Matsuda ISI, Predicted M ISI, and Stumvoll Index were assessed. Outcomes were analyzed to determine: (1) effects of the five SB; (2) effects of the proportions of fructose and glucose in all SB. (3) Results: Fructose-SB and the fructose component in mixed sugars negatively affected outcomes that assess hepatic insulin sensitivity, while glucose did not. The effects of glucose-SB and the glucose component in mixed sugar on muscle insulin sensitivity were more negative than those of fructose. (4) Conclusion: the effects of consuming sugar-SB on insulin sensitivity varied depending on type of sugar and ISI index because outcomes assessing hepatic insulin sensitivity were negatively affected by fructose, and outcomes assessing muscle insulin sensitivity were more negatively affected by glucose.

Remote Delivery of the Cuidándome Telehealth Intervention for Self-Management of Depression and Anxiety Among Latina Immigrant Women: Randomized Controlled Trial.

BACKGROUND: Growing evidence suggests that Latina immigrant survivors of adverse childhood experiences (ACEs) are at increased risk for developing and remaining with either depression or anxiety or both symptoms. This study examined the feasibility and acceptability of a telehealth intervention-Cuidándome (quee-DAN-doh-meh, "taking care of myself"). Cuidándome is a 10-week, patient-centered, trauma-informed intervention delivered by a trained facilitator that promotes self-management of depression and anxiety symptoms through improved problem-solving skills and strategies. OBJECTIVE: The aim of this study was to examine the feasibility and acceptability of Cuidándome delivered remotely (via Zoom) with Latina immigrant ACE survivors with either depression or anxiety or both symptoms. We also estimated the effect sizes associated with the intervention on decreasing depression and anxiety symptoms and improving social problem-solving styles. METHODS: We evaluated Cuidándome using a randomized controlled trial design. Latina immigrants (N=47) who had experienced at least 1 ACE and had at least mild depression or anxiety symptoms were randomized to Cuidándome or a comparison group delivered by trained facilitators. We assessed for changes in depression and anxiety symptoms as well as social problem-solving styles at baseline, post intervention, and 3- and 6-month follow-up. RESULTS: Analyses indicated significant decreases over time within both Cuidándome and comparison groups for depression and anxiety symptoms and maladaptive problem-solving. The intervention effect was largest for anxiety; at 6-month follow-up, Cuidándome participants had significantly lower anxiety scores than the comparison group. In addition, we observed a greater average point reduction in depression symptoms at 6 months among Cuidándome participants (5.7 points) than in the comparison group (3.7 points). CONCLUSIONS: A mental health program delivered via Zoom by a trained facilitator was feasible and acceptable to Latina immigrant women and can be beneficial for reducing anxiety and depression symptoms. More research is needed to assess the effectiveness of Cuidándome among a powered sample size of Latina immigrants. TRIAL REGISTRATION: ISRCTN Registry ISRCTN16668518; https://www.isrctn.com/ISRCTN16668518.

Design an Intervention Study.

Randomized controlled trials are commonly designed to compare the effectiveness of treatments in rheumatoid arthritis (RA). In a clinical trial (intervention study), researchers apply interventions or preventive services to patients and examine outcomes. Clinical trial design consists of the following categories: choice of intervention and control, selection of patients, informed consent, baseline measurement, bank specimens, randomized allocation and blinding, and outcome measurements. Here, we discuss the design of clinical trials for RA.

The impact of the COVID-19 pandemic on early termination of ophthalmology clinical trials: A cross-sectional analysis of ClinicalTrials.gov.

Objective: To study the effect of the COVID-19 pandemic on the early termination of ophthalmology clinical trials. Methods: On June 10, 2022, we searched ClinicalTrials.gov and identified clinical trials pertaining to eye diseases. We included trials last updated between January 1, 2020 and June 8, 2022, as ones possibly impacted by the pandemic. We selected all interventional trials in any stage and country that were "recruiting," "active, not recruiting," "enrolling by invitation," "suspended," "terminated," "completed," or "withdrawn" and excluded trials that had been completed or discontinued before 2020, had incomplete data, trials in which the eye was not the primary focus of the trial (e.g., Chediak-Higashi syndrome, myasthenia gravis). The following trial-level characteristics were collected: location, trial status, enrollment count, ocular condition, sponsors, intervention purpose, trial phase (I-IV), randomization, number of arms, and reasons for discontinuation. In addition to calculating descriptive statistics, we assessed whether trial characteristics differed between ophthalmology clinical trials canceled due to COVID-19 and those canceled for other reasons. Results: Following the screening, 2280/12,679 (18%) ophthalmology clinical trials were retained. Of these, 142 (6.2%) were discontinued between January 1, 2020 and June 8, 2022. Moreover, 34 out of 142 (23.9%) ophthalmology clinical trials were discontinued due to COVID-19. These trials were more likely to be sponsored by academic medical centers (26/34, 76.5% vs 57/108, 52.8%, p = 0.03) and were not assigned to a specific study phase, indicating they were not investigational new drugs (22/34, 64.7% vs 46/108 42.6%, p = 0.003). Conclusions: COVID-19-related trial discontinuations were more likely to be reported by academic medical centers and associated with trials investigating fully approved drugs, medical devices, procedures, diagnostic imaging, and behavioral changes. Further investigation of these characteristics may lead to a more robust and resilient understanding of the causes of early termination of these clinical trials.

The Role of Daily Steps in the Treatment of Major Depressive Disorder: Secondary Analysis of a Randomized Controlled Trial of a 6-Month Internet-Based, Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth.

BACKGROUND: Current evidence supports physical activity (PA) as an adjunctive treatment for major depressive disorder (MDD). Few studies, however, have examined the relationship between objectively measured PA and MDD treatment outcomes using prospective data. OBJECTIVE: This study is a secondary analysis of data from a 24-week internet-based, mindfulness-based cognitive behavioral therapy program for MDD. The purpose of this analysis was twofold: (1) to examine average daily step counts in relation to MDD symptom improvement, and whether pain moderated this relationship; and (2) to examine whether changes in step activity (ie, step trajectories) during treatment were associated with baseline symptoms and symptom improvement. METHODS: Patients from the Centre for Addiction and Mental Health were part of a randomized controlled trial evaluating the effects of internet-based, mindfulness-based cognitive behavioral therapy for young adults (aged 18-30 years old) with MDD. Data from 20 participants who had completed the intervention were analyzed. PA, in the form of objectively measured steps, was measured using the Fitbit-HR Charge 2 (Fitbit Inc), and self-reported depression severity was measured with the Beck Depression Inventory-II (BDI-II). Linear regression analysis was used to test PA's relationship with depression improvement and the moderating effect of pain severity and pain interference. Growth curve and multivariable regression models were used to test longitudinal associations. RESULTS: Participants walked an average of 8269 steps per day, and each additional +1000-step difference between participants was significantly associated with a 2.66-point greater improvement (reduction) in BDI-II, controlling for anxiety, pain interference, and adherence to Fitbit monitoring (P=.02). Pain severity appeared to moderate (reduce) the positive effect of average daily steps on BDI-II improvement (P=.03). Higher baseline depression and anxiety symptoms predicted less positive step trajectories throughout treatment (Ps≤.001), and more positive step trajectories early in the trial predicted greater MDD improvement at the end of the trial (Ps<.04). However, step trajectories across the full duration of the trial did not significantly predict MDD improvement (Ps=.40). CONCLUSIONS: This study used objective measurements to demonstrate positive associations between PA and depression improvement in the context of cognitive behavioral treatment. Pain appeared to moderate this relationship, and baseline symptoms of anxiety and depression predicted PA trajectories. The findings inform future interventions for major depression. Future research with larger samples should consider additional moderators of PA-related treatment success and the extent to which outcomes are related to PA change in multimodal interventions. TRIAL REGISTRATION: Clinical Trials.gov NCT03406052; https://www.clinicaltrials.gov/ct2/show/NCT03406052. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11591.

Consistent exercise timing as a strategy to increase physical activity: A feasibility study.

Introduction/Purpose: Observational research suggests that consistent exercise timing could be leveraged to promote moderate-to-vigorous physical activity (MVPA) among adults with obesity. However, the feasibility and acceptability of prescribed consistent exercise timing in a free-living setting is unknown. The purpose of this study was to assess the feasibility and acceptability of prescribed consistent exercise timing in a free-living setting among inactive adults with obesity (primary) and to compare MVPA timing prescriptions and characterize exercise barriers/facilitators (secondary). Methods: Using a within-subjects design, inactive adults with obesity (n=15) were randomized in counterbalanced order to three 3-wk exercise timing conditions separated by 2-wk washout periods: 1) consistent morning, 2) consistent evening, and 3) choice timing (control). Feasibility was assessed using prespecified benchmarks. Acceptability and preferred timing were assessed with questionnaires post-intervention. Secondarily, exercise timing and MVPA were assessed via accelerometry and nightly surveys and barriers/facilitators were assessed with nightly surveys. Results: All feasibility benchmarks were achieved (e.g., timing adherence = 69.9% via accelerometry and 87.4% via self-report (target: ≥60%)). Consistent exercise timing was acceptable (mean rating = 3.7 of 5 (target: ≥3.5)). Choice was the most popular prescription. There were medium- to large-sized effects (partial η2 of 0.09-0.16) of condition on MVPA; MVPA was higher during the morning and evening conditions versus choice condition. Facilitators were similar across conditions, while some barriers were time specific. Conclusion: Prescribed exercise timing in a free-living setting appears feasible and acceptable. While choice timing was most preferred, consistent timing appeared most effective for increasing MVPA. Data warrant larger trials to test the efficacy and mechanisms of consistent exercise timing as a translational strategy for promoting MVPA. Pending findings from a fully powered randomized trial, practitioners interested in promoting MVPA among their patients or clients could consider encouraging exercise at a consistent time day-to-day.

Influencia de la musicoterapia en el paciente durante la atención estomatológica

Ser atendido por el estomatólogo es una de las situaciones que genera más miedo y ansiedad en las personas. Se sugiere que la musicoterapia contribuye a reducir estos síntomas. Teniendo en cuenta que muchos pacientes presentan ansiedad y miedo al ser atendidos en el sillón dental y que necesitan un ambiente más agradable, constituye el motivo que condujo a la realización de este trabajo haciendo uso de la musicoterapia con el objetivo de evaluar su influencia en el paciente durante la atención. Se realizó un estudio de intervención, desde marzo a junio del 2022 en el Servicio Estomatológico, Policlínico Tula Aguilera. La muestra, 40 pacientes, fue seleccionada al azar, independientemente de sentir temor o no al tratamiento estomatológico. Las sesiones se dividieron: primera visita (sin música) y segunda visita (con música). Los datos se recogieron en encuesta. Los niveles de miedo disminuyeron con la aplicación de la terapia, por lo cual se constató que la musicoterapia tiene una notable influencia en los pacientes al desaparecer y disminuir el miedo o sensaciones desagradables durante la atención estomatológica. Todos los pacientes manifestaron satisfacción con el uso de la música, durante el servicio.

To be assisted by the odontologist is one of the situations that generates more fear and anxiety in people. It is suggested that the musical-therapy contributes to reduce these symptoms. Keeping in mind that many patients present anxiety and fear when being assisted in the dental armchair and that they need a more pleasant atmosphere, it constitutes the reason that led to the realization of this work making use of the musical-therapy with the objective of evaluating their influence in the patient during the attention. He was carried out an intervention study, from March to June of the 2022 in the Dentistry Service, Clinical Tula Aguilera. The sample, 40 patients, it was selected at random, independently of feeling fear or not to the dentistry treatment. The sessions were divided: first visit (without music) and second visit (with music). The data were picked up in survey. The levels of fear diminished with the application of the therapy, reason why it was verified that the musical-therapy has a notable it influences in the patients when disappearing and to diminish the fear or unpleasant sensations during the dentristry attention. All the patients manifested satisfaction with the music's use, during the service.