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AbstractBackgroundMaterials and methodsResultsConclusionBrief Admission by self-referral (BA) is a crisis-management intervention standardized for individuals with self-harm at risk of suicide. We analyzed its health-economic consequences.BA plus treatment as usual (TAU) was compared with TAU alone in a 12-month randomized controlled trial with 117 participants regarding costs for hospital admissions, coercive measures, emergency care and health outcomes (quality-adjusted life years; QALYs). Participants were followed from 12 months before baseline to up to five years after.Over one year BA was associated with a mean annual cost reduction of 4800 or incremental cost of 4600 euros, depending on bed occupancy assumption. Cost-savings were greatest for individuals with >180 admission days in the year before baseline. In terms of health outcomes BA was associated with a QALY gain of 0.078. Uncertainty analyses indicated a significant QALY gain and ambiguity in costs, resulting in BA either dominating TAU or costing 59 000 euros per gained QALY.BA is likely to produce QALY gains for individuals living with self-harm and suicidality. Cost-effectiveness depends on targeting high-need individuals and comparable bed utilization between BA and other psychiatric admissions. Future research should elaborate the explanatory factors for individual variations in the usage and benefit of BA. [ABSTRACT FROM AUTHOR]

Cancer-related fatigue (CRF) is unrelenting. As neither rest nor sleep ameliorates cognitive, emotional, and physical symptoms, quality of life is diminished. This study examines resistance training (RT) effectiveness on CRF in cancer survivors. The secondary aims were to identify the dose-response relationship of RT frequency, intensity, and volume on CRF in different cancer survivor populations. Systematic searches via numerous databases for RCTs were performed in June 2022. Patient-reported outcome measures (PROM), were analysed, pre-to-post intervention, using a random-effects model. The Physiotherapy Evidence Database (PEDro) scale informed methodological quality assessment. Eight studies were included (cancer survivors: breast (BCS) = 5; endometrial (ECS) = 1; prostate (PCS) = 2). Overall, RT interventions ≥ 6 weeks elicited large significant reductions in CRF for FACIT-F (SMD = 0.932, p = <0.001) and moderate significant reductions in CRF for PFS-R (SMD = −0.622, p = 0.004). Main findings indicate that RT ameliorates CRF, especially in BCS; however, individualised approaches should be advocated. Supervised training elicited the greatest positive outcomes, thus should be a pivotal part of the cancer rehabilitation pathway. Future studies should be adequately powered, undertake discrete analyses of different cancer types, and investigate chronic RT effects. Cancer-related fatigue (CRF) is debilitating and distressing, leading to reduced quality of life and function in cancer survivors. Considerable heterogeneity exists in disease histology and clinical patient presentation. Individualised resistance training (RT) is an effective, safe, and accessible intervention to mitigat:e fatigue levels, thus aid function, most notably in breast cancer survivors [ABSTRACT FROM AUTHOR]

To verify the effectiveness of experimental occupational therapy plus intensive standard rehabilitation compared to intensive standard rehabilitation alone on the reintegration to social activities of complex patients three months after hospital discharge. Patients with a score ≥ 9 on the Rehabilitation Complexity Scale at admission to an intensive rehabilitation ward were randomized to the control or experimental group. Both groups received intensive multidisciplinary rehabilitation aimed at recovering independence in the basic activities of daily life (ADL). The experimental group also received experimental occupational therapy services to address goals identified through the administration of the Canadian Occupational Performance Measure (COPM). Experimental occupational therapy began during the in-hospital phase and continued in the home-based setting. It consisted of teaching strategies, recommending aids, and providing personalized information regarding available community support. Ninety-two individuals with a mean age of 65 years (female 44.6%) were enrolled. The experimental group significantly improved participation measured by the Reintegration to Normal Living Index (mean changes 8.61, 95% CI: 1–16.23, p = 0.027). The performance and satisfaction scores of the COPM, both during hospitalization and after discharge, and independence in ADL also improved. No differences in mood disturbances were found. Early post-discharge occupational therapy integrated with multidisciplinary rehabilitation improves the social participation of complex patients. Future research should investigate the concrete feasibility of implementing this complex intervention cost-effectively and in different contexts. ClinicalTrials.gov Identifier NCT03668938 (first posted date 13/09/2018) Early post-discharge rehabilitation assists patients' transition from hospital to home by improving the management of problems they encounter. In complex patients, occupational therapy initiated during hospitalization and extended to the early post-discharge phase improves social participation, independence in basic and instrumental daily activities, and performance and satisfaction when carrying out relevant occupational activities. The strong partnership between the Occupational Therapist and the patient improves compliance to treatment, enhancing the chances of success of rehabilitation interventions. [ABSTRACT FROM AUTHOR]

Smoking is the single factor with the highest impact on reducing life expectancy of patients with mental illness. Patients experience difficulty in participating in smoking cessation programs but are concerned about the impact of tobacco on their health and finances. Smoking cessation advice via videoconferencing might be an alternative to an ordinary in-person consultation. Randomized controlled trial with follow-up at 6 months. We included patients with diagnoses of schizophrenia and affective disorder from psychiatric outpatient clinics. Intervention 1 involved daily video consultations; intervention 2 was treatment as usual. Seventy patients were included. For both/all groups/interventions, rates of smoking cessation were 45% and predictors for a 50% reduction in smoking were antipsychotic medication load [odds ratio (OR) 0.54; p = 0.045] and number of nicotine patches (OR 1.02; p = 0.06). Predictors for a reduction in the number of cigarettes to < 10 were antipsychotic medication load (OR 0.52; p = 0.04), number of nicotine patches (OR 1.01; p = 0.02) and number of cigarettes at baseline [OR 0.95 (p = 0.09); adjusted OR 0.94 (p = 0.02)]. Patients prevented weight gain during the cessation period. The smoking cessation rate was high. One of the reasons for the high cessation rate was that the intervention was carried out by highly experienced and professionally qualified staff. In addition, we used free nicotine patches to increase the patients' motivation to quit smoking. It is very important that we introduce these results into our clinical work with the patients. [ABSTRACT FROM AUTHOR]

Coping Power (CP) is an evidence-based manualized group therapy targeting child conduct problems at the family level. We examined maternal-internalizing problems (e.g., depressive and anxiety symptoms) as a predictor of treatment response for children with disruptive behavior when comparing group treatment (CP) versus non-standardized individualized treatment. Ninety-three mothers participated. CP was similar or better than individual treatment for families with maternalinternalizing problems. Marginally significant improvements in child conduct problems and inconsistent discipline were found among mothers in CP with internalizing problems. Findings highlight the potential efficacy of CP for child and parenting needs among families with maternal-internalizing problems. [ABSTRACT FROM AUTHOR]

Entertainment-education has been touted as a potent delivery channel for health education campaigns. Yet, there is little evidence of its causal effects. This paper aims to fill the gap in the literature by using a field experiment in India to study two questions on the efficacy of health entertainment-education. First, can health entertainment-education, particularly through films that show role models and draw on emotions, lead to lasting, positive change in health knowledge and behavior? Second, can financial incentives for ex-post health literacy boost the effectiveness of health entertainment-education? The results show that health entertainment-education successfully increased health knowledge (e.g. knowledge about cleanliness and hygiene) by 16 percent. These gains persist almost one year later, although there were no observed impacts on health behaviors. Further, financial incentives do not appear to have any effects. These insights contribute to our knowledge of what works for health education in low-income settings, so that future education campaigns can be crafted with more meaningful impact. [ABSTRACT FROM AUTHOR]

AbstractObjectiveDesign and methodsResultsConclusionTo examine the effects of an empowerment-based interprofessional lifestyle intervention program among people at risk of type 2 diabetes on knowledge, skills, and confidence in self-management, health, psychological well-being, and lifestyle characteristics, and to explore the participants’ perceptions of participating in the intervention.In line with the Medical Research Council complex interventions research methods framework, we conducted a randomized controlled trial with embedded qualitative interviews in primary healthcare clinics in Norway between 2019–2021. Of the patients at risk (The Finnish Diabetes Risk Score Calculator (FINDRISC) ≥15 or Body Mass Index (BMI) ≥30) 142 accepted the invitation, and 14 participants from the intervention group participated in individual interviews after the 12-month follow-up. Our primary outcome was the Patient Activation Measure (PAM-13). Secondary outcomes were EQ-5D-5L, EQ-VAS, WHO-Overall health, WHO-Overall QOL, weight, height, waist circumference, and regularity of physical activity. We used thematic analysis to analyse the qualitative data.There was no clinically relevant differences of neither the primary nor the secondary endpoints between intervention and control group. As to the qualitative data, we identified two distinct features: ‘Meaningful perspectives on lifestyle changes’ and ‘Lifestyle change is not a linear process due to challenges faced along the way’ putting ownership of their choices in life into picture.The negative results of the RCT stand in contrast to the findings given by the participants voices, perceiving the intervention as a key eye opener placing their health challenges in perspective. How to interpret these seemingly conflicting findings of participants being seen, heard, and understood, helping them to take more conscious ownership of their choices in life, and at the same time demonstrating no improvements in symptoms or measures, is a dilemma that needs further exploration. We should be careful to implement interventions that do not demonstrate any effects on the quantitative outcomes. [ABSTRACT FROM AUTHOR]

AbstractBackground and objective: Cognitive–behavioral therapy (CBT) for somatoform disorders (SFDs) is understudied in China. Western findings may not be applicable to Chinese culture. This preliminary study evaluated the efficacy of CBT for patients in China, relative to treatment-as-usual (TAU). Methods: Seventy patients with SFDs randomly received either combined CBT and TAU (CBT + TAU), or TAU alone between January 2018 to May 2019. The CBT + TAU group received 12 weekly individual 50-minute CBT sessions. Participants were blindly assessed at 4 timepoints (baseline, week 6, end of treatment: week 12; 12 weeks post-treatment: week 24) using the following outcome measures: SQSS (Self-screening Questionnaire for Somatic Symptoms); PHQ-15 (Patient-Health-Questionnaire-15) and the WI (Whiteley Index); GAD-7 (General Anxiety Disorder-7); HAMD-17 (Hamilton Depression Rating Scale-17); Family Burden Interview Schedule (FBIS); Sheehan Disability Scale (SDS); and the Short Form of Quality-of-Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). The primary endpoint was the difference between the SQSS total score at week 24 and the baseline. A mixed model for repeated measures was used to analyze inter- and intra-group changes from the baseline. Results: At week 24, The least-squares mean (LSM) change of the total score on the SQSS was −18.87 points and −9.69 points, respectively in the CBT + TAU group and in the TAU group (LSM difference, −9.18 points; 95% confidence interval, −15.72 to −2.64; P = 0.0068). At week 24, the LSM changes from baseline in the WI, HAMD, PHQ15, FBIS and SDS total scores were significantly different between the two groups, however, there was no significant difference in the Q-LES-Q-SF. The SQSS of group effect sizes were 0.63 at 24 weeks. The dropout rates of the CBT + TAU and TAU groups were comparable (22.9% and 19.3%). Conclusions: These preliminary findings suggest that CBT may be helpful for improving the symptoms of patients with SFDs in China. [ABSTRACT FROM AUTHOR]

Observational research suggests higher red and processed meat intakes predict greater risks of developing or dying from cardiovascular diseases (CVD) and type 2 diabetes mellitus (T2DM), but this research limits causal inference. This systematic review of reviews utilizes both observational and experimental research findings to infer causality of these relations. Reviews from four databases were screened by two researchers. Reviews included unprocessed red meat (URM), processed meat (PM), or mixed URM + PM intake, and reported CVD or T2DM outcomes. Twenty-nine reviews were included, and causality was inferred using Bradford Hill's Criteria. Observational assessments of CVD outcomes and all meat types consistently reported weak associations while, T2DM outcomes and PM and Mixed URM + PM assessments consistently reported strong associations. Experimental assessments of Mixed URM + PM on CVD and T2DM risk factors were predominately not significant which lacked coherence with observational findings. For all meat types and outcomes, temporality and plausible mechanisms were established, but specificity and analogous relationships do not support causality. Evidence was insufficient for URM and T2DM. More experimental research is needed to strengthen these inferences. These results suggest that red and processed meat intakes are not likely causally related to CVD but there is potential for a causal relationship with T2DM. [ABSTRACT FROM AUTHOR]

Frequent attenders in primary care (FAs) consume a disproportionate amount of healthcare resources and often have depression, anxiety, chronic health issues, and interpersonal problems. Despite extensive medical care, they remain dissatisfied with the care and report no improvement in quality of life. To pilot a Telephone-based Interpersonal Counseling intervention for Frequent Attenders (TIPC-FA) and assess its feasibility and efficacy in reducing symptoms and healthcare utilization. Top 10% of primary care visitors were randomly assigned to TIPC-FA, Telephone Supportive Contact (Support), or Treatment as Usual (TAU). TIPC-FA and Support groups received six telephone sessions over twelve weeks, while the TAU group was interviewed twice. Multilevel regression tested for changes over time, considering patient and counselor variance. TIPC-FA and Support groups demonstrated reduced depressive symptoms, and the TIPC-FA group showed decreased somatization and anxiety. The TIPC-FA group demonstrated a trend towards less healthcare utilization than the TAU group. This pilot study suggests that IPC via telephone outreach is a feasible approach to treating FAs, achieving a reduction in symptoms not seen in other groups. Promising reduction in healthcare utilization in the TIPC-FA group warrants further exploration in larger-scale trials. [ABSTRACT FROM AUTHOR]

Mobile health applications (mHealth apps) may lead to health benefits. In recent years, the use of apps in multiple sclerosis (MS) has increased. Apps to train and improve dexterity in MS are scarce. This study investigated the effectiveness of a tablet app-based home-based training to improve dexterity in individuals with MS. In a randomized controlled trial, two standardized 4-week home-based interventions focussing on different aspects of dexterity and upper limb function were compared. Assessments were done at baseline, post-intervention and 12-week follow-up. The primary endpoint was the Arm Function in Multiple Sclerosis Questionnaire, a dexterity-related measure of patient-reported activities of daily living. Secondary endpoints were dexterous function, grip strength and health-related quality of life. Forty-eight individuals were randomly assigned to a tablet app-based program (n = 26) or a control strengthening exercise program (n = 22). No significant differences were found for the primary endpoint (p = 0.35). Some significant differences in favour of the app-group were found in fine coordinated finger movements and strength. No significant differences were found at the 12-week follow-up for all endpoints. Adherence in both groups was above 90%. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. However, app-based training was found to be effective in improving specific dimensions (finger movements and strength), and can easily be applied at home. Therefore, individuals living with MS with impaired dexterity should consider app-based training. Clinicaltrials.gov NCT03369470. This study provides initial evidence for the effectiveness of a home-based app-based program for improving dexterous function in individuals living with multiple sclerosis through the implementation of a tablet app-based dexterity training. App-based training was not superior compared to a control strengthening exercise program concerning the arm- and hand function from the participant's perspective. Patients attending the app-based dexterity program showed some statistically significant improvements in fine coordinated finger movements and strength. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusionThis study aims to comprehensively verify the efficacy of Buyang Huanwu Decoction in improving cognitive function in patients with diabetes.Patients clinically diagnosed with mild cognitive impairment (MCI) assigned to either the placebo group or the Buyang Huanwu Decoction group. After strict screening and exclusions, a total of 156 participants completed the clinical trial, with 76 in the placebo group and 80 in the Buyang Huanwu Decoction group.After treatment, Buyang Huanwu Decoction group showed higher Mini-Mental State Examination and Montreal Cognitive Assessment scores compared to placebo (p < 0.05). Memory and Executive Screening, Boston Naming Test, and Animal Fluency Test scores were also higher in the treatment group (p < 0.05). No significant differences were found in DST and CDT scores (p > 0.05). Trail Making Test scores were lower in the treatment group (p < 0.05). No significant difference was observed between the two groups in terms of complications (p > 0.05).Patients receiving Buyang Huanwu Decoction treatment demonstrated improvement in cognitive function, showing positive effects and providing preliminary evidence for the role of Buyang Huanwu Decoction in improving cognitive function in patients with diabetes. This suggests its potential for clinical application and further promotion. [ABSTRACT FROM AUTHOR]

AbstractLittle is known about the scope of use-of-force incidents in carceral settings, nor the impact of efforts to control it. Correctional agencies have recently begun adopting body-worn cameras (BWCs) to mitigate such incidents and improve institutional management. We conducted a one-year randomized controlled trial of BWCs among the 12 housing units in the Loudoun County Adult Detention Center in Virginia. We collected data on the 97 response-to-resistance (RTR) events that occurred during our study period, including deputies’ control methods (physical controls, restraints, weapons) and residents’ resistance levels (passive, active, aggressive) during these events. Using negative binomial regression, we found a 40% decrease in RTR events in unit-months with BWCs. We also found 37% and 52% reductions in the use of physical controls by deputies and the occurrence of resident active resistance, respectively. We situate these findings in the correctional context and discuss their implications for policy and future research. [ABSTRACT FROM AUTHOR]

Conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy of individual humanistic-experiential therapies (HEPs) for depression. Database searches (Scopus, Medline, and PsycINFO) identified RCTs comparing any HEP intervention with a treatment-as-usual (TAU) control or active alternative intervention for the treatment of depression. Included studies were assessed using the Risk of Bias 2 tool and narratively synthesized. Post-treatment and follow-up effect sizes were aggregated using random-effects meta-analysis and moderators of treatment effect were explored (PROSPERO: CRD42021240485). Seventeen RCTs, synthesized across four meta-analyzes, indicated HEP depression outcomes were significantly better than TAU controls at post-treatment (g = 0.41, 95% CI [0.18, 0.65], n = 735), but not significantly different at follow-up (g = 0.14, 95% CI [−0.30, 0.58], n = 631). HEP depression outcomes were comparable to active treatments at post-treatment (g = −0.09, 95% CI [−0.26, 0.08], n = 2131), but significantly favored non-HEP alternative interventions at follow-up (g = −0.21, 95% CI [−0.35, −0.07], n = 1196). Relative to usual care, HEPs are effective in the short-term and comparable to non-HEP alternative interventions at post-treatment, but not at follow-up. However, imprecision, inconsistency, and risk of bias concerns were identified as limitations of the evidence included. Future large-scale trials of HEPs with equipoise between comparator conditions are required. [ABSTRACT FROM AUTHOR]

Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. R000038375 UMIN000033926 Individuals with stroke often collide with the paretic side while walking through narrow spaces. Training for walking through a narrow opening from the paretic side improved an individual's ability to avoid obstacles in similar tasks. Moreover, such training could improve patient outcomes/safety because such interventions may temporarily increase attentional focus to the paretic side in specific tasks. [ABSTRACT FROM AUTHOR]

Randomized experiments allow for consistent estimation of the average treatment effect based on the difference in mean outcomes without strong modeling assumptions. Appropriate use of pretreatment covariates can further improve the estimation efficiency. Missingness in covariates is nevertheless common in practice, and raises an important question: should we adjust for covariates subject to missingness, and if so, how? The unadjusted difference in means is always unbiased. The complete-covariate analysis adjusts for all completely observed covariates, and is asymptotically more efficient than the difference in means if at least one completely observed covariate is predictive of the outcome. Then what is the additional gain of adjusting for covariates subject to missingness? To reconcile the conflicting recommendations in the literature, we analyze and compare five strategies for handling missing covariates in randomized experiments under the design-based framework, and recommend the missingness-indicator method, as a known but not so popular strategy in the literature, due to its multiple advantages. First, it removes the dependence of the regression-adjusted estimators on the imputed values for the missing covariates. Second, it does not require modeling the missingness mechanism, and yields consistent estimators even when the missingness mechanism is related to the missing covariates and unobservable potential outcomes. Third, it ensures large-sample efficiency over the complete-covariate analysis and the analysis based on only the imputed covariates. Lastly, it is easy to implement via least squares. We also propose modifications to it based on asymptotic and finite sample considerations. Importantly, our theory views randomization as the basis for inference, and does not impose any modeling assumptions on the data-generating process or missingness mechanism. for this article are available online. [ABSTRACT FROM AUTHOR]

This randomized controlled trial aimed to assess the efficacy of the Homebound Elderly People Psychotherapeutic Intervention (HEPPI), a home-delivered cognitive-emotional intervention, among the homebound older population presenting with mild cognitive impairment and depressive or anxiety symptoms. Participants were randomly assigned either to the intervention group or the treatment-as-usual group and completed baseline, post-intervention, and three-month follow-up assessments. Changes in episodic memory and symptoms of depression and anxiety were the primary outcomes. Secondary outcomes included changes in global cognition, attentional control, subjective memory complaints, functional status, and quality of life. Data were analyzed on an intention-to-treat basis employing a linear mixed models approach. ClinicalTrials.gov identifier: NCT05499767. Compared with the treatment-as-usual group, the HEPPI group reported significant immediate improvement in cognition, mood, and daily functional performance. Positive effects of HEPPI were maintained over the follow-up phase only in depressive symptomatology, perceived incapacity to perform advanced instrumental activities of daily living, and self-reported emotional ability. A significant impact of the intervention on the subjective memory complaints level was observed only three months after the intervention. This study suggests that HEPPI may be a promising home-delivered cognitive-emotional intervention to help homebound older adults improve their mental health. [ABSTRACT FROM AUTHOR]

AbstractObjective: This randomized controlled trial investigated the efficacy of dynamic relational group therapy (DRT) relative to group psychodynamic supportive therapy (PST) in improving perfectionism-related attitudes and components of the perfectionistic self-relationship. Method: Based on a comprehensive conceptualization of perfectionism, 80 community-recruited, highly perfectionistic individuals were randomly allocated to 12 sessions of group DRT (n = 41; 5 groups) or group PST (n = 39; 5 groups). Patients completed measures of dysfunctional attitudes, self-criticism, self-esteem, and self-reassurance at pre-, mid-, and post-treatment, and six months post-treatment. Results: Multigroup latent growth curve modeling revealed significant (p < .05) decreases in dysfunctional attitudes, concern over mistakes, two types of self-criticism, and self-esteem problems, along with a significant increase in self-reassurance, from pre-treatment to six-month follow-up in both DRT and PST. Moderate-to-large between-group differences favoring DRT over PST were found for dysfunctional attitudes and self-reassurance. A majority of patients in both conditions maintained reliable improvement at six-month follow-up in dysfunctional attitudes, concern over mistakes, and self-criticism focused on inadequacy. Conclusion: Findings provide evidence for the use of psychodynamic group therapy approaches in treating perfectionism-related attitudes and self-relational elements of perfectionism, and support the relative efficacy of DRT for dysfunctional attitudes and self-reassurance. [ABSTRACT FROM AUTHOR]

This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia. This monocenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial (registration number: DRKS00003261) was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505–0.773, Student's t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student's t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment. Trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy of ubrogepant 50 mg versus 100 mg daily for migraine remained controversial. We conducted a systematic review and meta-analysis to compare the efficacy and safety of ubrogepant 50 mg versus 100 mg daily on treatment in migraine patients. Methods: We have searched PubMed, EMbase, Web of science, EBSCO, Cochrane library databases and SCOPUS through 21 March 2022 for randomized controlled trials (RCTs) assessing the effect of ubrogepant 50 mg versus 100 mg on treatment efficacy in migraine patients. This meta-analysis was performed using the random-effect model. Results: Three RCTs were included in the meta-analysis. Overall, compared with ubrogepant 100 mg in migraine patients, ubrogepant 50 mg obtained comparable pain freedom at 2 h (OR = 0.86; 95% CI = 0.64–1.15; p = 0.310), sustained pain freedom 2–24 h (OR = 0.76; 95% CI = 0.54–1.07; p = 0.110), photophobia absence at 2 h (OR = 0.80; 95% CI = 0.63–1.02; p = 0.070), phonophobia absence at 2 h (OR = 1.07; 95% CI = 0.82–1.40; p = 0.620) and nausea absence at 2 h (OR = 1.02; 95% CI = 0.79–1.32; p = 0.880). In terms of safety, adverse events were found to be increased in ubrogepant 100 mg as compared to ubrogepant 50 mg (OR = 0.81; 95% CI = 0.67–0.99; p = 0.040), and there was no statistical difference of serious adverse events between two groups (OR = 0.87; 95% CI = 0.40–1.91; p = 0.720). Conclusions: Ubrogepant 50 mg and 100 mg may be equally effective to alleviate migraine, but ubrogepant 100 mg led to increase incidence of adverse events. [ABSTRACT FROM AUTHOR]

The aim of this randomized controlled trial was to evaluate an adapted cognitive behavioural therapy (CBT) programme for treating anxiety in adolescents with acquired brain injury (ABI). Participants with ABI (12–19 years, N = 36) recruited from two sites were randomly allocated into either the intervention receiving 11 sessions of CBT (n = 19) or a wait-list control group (n = 17). The primary outcome was participants' anxiety and secondary outcomes were participants' depression, self-perception, and participation in daily activities, and parental stress, measured at (i) pre-intervention, (ii) immediately post-intervention, (iii) 2 months post-intervention and (iv) 6 months post-intervention. Repeated measures ANOVAs revealed significant treatment effects with the intervention group demonstrating greater improvements in self-reported anxiety, as well as self- and parent-reported depression from pre- to immediately post-treatment, compared to wait-list controls. Little evidence of treatment effects was found for the remaining outcomes (parent-reported anxiety, self-perception, daily participation, and parental stress). Significant improvement in self-reported anxiety found immediately post-treatment was maintained at two- and six-month follow-up. Findings provide support for adapted CBT as an effective means of reducing anxious and depressive symptomatology in adolescents with ABI compared to waitlist controls, and offer support for the use of these techniques to manage anxiety in this population. [ABSTRACT FROM AUTHOR]

Private school choice programs' success depends partly on the supply of private schools. Many parents prioritize a religious education for their children. Therefore, it is important to consider how religious private schools may respond to various program regulations. We conducted an experimental study surveying a national sample of 354 leaders of Association of Christian Schools International (ACSI) member schools, the second largest private school organization of any kind in the United States. We find evidence that while over four-fifths of Christian school leaders are inclined to participate with no changes to school operations, open enrollment mandates reduce participation rates by 62 percentage points and employment regulations reduce participation rates by 79 percentage points. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has tremendous impact on public mental health and on psychological resources such as optimism. In this context, positive psychological interventions like the best possible self (BPS) intervention may be useful tools for resource activation. Therefore, a randomized controlled trial, conducted between January and December 2021, compared BPS (n = 87), C-BPS (n = 85), and daily activity writing groups (DA; n = 82) on psychological outcomes. Each group completed a writing task over four consecutive weeks. Data were analysed using repeated measures ANCOVA, controlling for age, gender, educational attainment, relationship status, current work status, dyslexia (perceived or diagnosed), and perceived social support. The BPS led to short-term increases in positive affect and mood, and decreases in negative affect. However, this effect was limited to the first week, but the trajectories suggest temporal trends that warrant further investigation. In addition, the approach holds promise for specific groups (e.g. people with depression). [ABSTRACT FROM AUTHOR]

Purpose: To determine the effect of auricular acupuncture on preoperative blood pressure (BP) elevation in different age groups. Materials and methods: Auricular acupuncture treats elevated BP among patients before surgery. This prospective, randomized clinical trial was performed at Li Huili Hospital of Ningbo Medical Center, China, from January to June 2021. We prospectively enrolled 120 patients with elevated BP aged 45 to 75 and observed them in the inpatient department. Patients were randomly assigned in a 1:1 ratio to undergo auricular acupuncture or sham control groups. In addition to usual care, the study group underwent auricular acupuncture bilaterally at HX6 7i-Ear apex, TF4-Shen men, TF1-Superior triangular fossa, and CO15-Heart. Results: A total of 120 patients completed the study, 60 in the study group and 60 in the control group. Of these, 76 (63.3%) were men, and the mean (standard deviation) was 64.55 (9.48) years. The differences in systolic BP comparisons after intervention were significant (7.88 mmHg; 95% confidence interval [CI], 2.94 to 12.81; P = .002). Diastolic BP also showed statistical significance (5.85 mmHg; 95% CI, 3.05 to 8.64; P < .01. Neither AA-related adverse events nor serious adverse events occurred. Stratified by age, the differences comparisons of systolic BP (-10.13 mmHg; 95% confidence interval [CI], -16.69 to -3.57; P < .01) and diastolic BP (-7.65 mmHg; 95% confidence interval [CI], -11.17 to -4.14; P < .01) were statistically significant for participants aged 60-75 years; The differences comparison of systolic BP (-2.37 mmHg; 95% confidence interval [CI], -8.04 to 3.31; P = .40) and diastolic BP (-1.46 mmHg; 95% confidence interval [CI], -5.68 to 2.76; P = .48) were not significant aged 45-59. Conclusion: Auricular acupuncture can reduce BP before procedures. However, further research is needed on the antihypertensive effect on people aged 45-59. These findings provide clinicians with evidence of auricular acupuncture as a standard adjunctive therapy targeting this patient population. [ABSTRACT FROM AUTHOR]

Background: Randomized controlled trials have demonstrated that Songling Xuemaikang capsule (SXC) is effective in blood pressure (BP) lowering for essential hypertension. However, the effectiveness of SXC in real-world clinical practice remains unknown. We aimed to investigate whether the BP-lowering effectiveness of SXC in the real-world practice setting is comparable to the efficacy of the intervention in a randomized controlled trial. Methods: We included 1325 patients treated with SXC monotherapy from a real-world registry and 300 from the SXC-BP trial. A propensity score matching (PSM) approach was used to select participants from the two cohorts. The primary outcome was a change in the office of BP from baseline to 8 weeks. Results: After PSM, there were 552 patients for the comparative analysis. Clinically meaningful BP reductions were observed both in the real world and in the RCT cohorts after 8-week SXC treatment. The 8-week systolic/diastolic BP was 129.50/81.33 mm Hg vs. 134.97/84.14 mm Hg in the real-world population and the RCT population, respectively. The changes in systolic BP (15.82 ± 10.71 vs. 10.48 ± 10.24; P < .001), and diastolic BP (10.01 ± 7.73 vs. 7.75 ± 8.14; P = .001) from baseline to 8 weeks were significantly greater in the real-world population. Conclusion: The current comparison demonstrated that SXC monotherapy is at least as effective in realworld settings as within the randomized controlled trial for BP lowering in patients with grade 1 hypertension. [ABSTRACT FROM AUTHOR]

The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome. This multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints. No thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%, p <.05). Finally, adverse events were more frequent in warfarin-treated patients. This study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome. ChiCTR-IPR-17013428. [ABSTRACT FROM AUTHOR]

Despite sedentary behavior being ubiquitous in students and detrimental to health, interventions specifically targeting it are mostly restricted to leisure time screen time reduction. With six weekly sessions alongside a poster campaign and an additional teacher intervention, the Let’s Move It trial delivered environmental and psychological strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in vocational schools, an understudied environment for behavioral interventions. Participants in the intervention arm considerably reduced sedentary time post-intervention. To investigate how social cognitions about restricting SB, as defined by the Reasoned Action Approach, change in intervention and control arms, self-reported data on social cognitions was collected as part of a cluster-randomized controlled trial from 1166 students (59% female, mage = 18.7 years, range: 16–49) in six vocational schools before, post-intervention, and 14 months post-baseline. Data were analyzed using mixed between-within repeated measures ANOVA. We found greater improvements in intention (F(1, 833) = 9.69; η2 p = 0.01; p = .018) and descriptive norms (F(1, 831) = 13.25; η2 p = 0.016; p < .001) in the intervention than control arm, but these effects depended on the included control variables. Generally, intervention effects leveled off from post-intervention to follow-up. The Let’s Move It intervention for SB reduction showed modest, short-lived effects on social cognitions, indicating that changes in behavior are likely due to other factors like changes to the classroom environment. Optimally, SB reduction interventions should not only change behavior but produce robust changes in conscious intentions to restrict one’s sitting, so that positive effects generalize to other contexts. [ABSTRACT FROM AUTHOR]

Approximately one-fifth of new parents struggle with unwanted intrusive thoughts (UITs) about intentionally harming their child. This study evaluated the initial efficacy, feasibility and acceptability of a novel online self-guided cognitive intervention for new parents with distressing UITs. Self-recruited parents (N = 43, 93% female, age 23–43 years) of children 0–3 years reporting daily distressing and impairing UITs were randomized to the 8-week self-guided online cognitive intervention or to waiting-list. The primary outcome was change on the Parental Thoughts and Behaviour Checklist (PTBC) from baseline to week 8 (post-intervention). The PTBC and negative appraisals (mediator) were assessed at baseline, weekly, post-intervention and at the 1-month follow-up. Results showed that the intervention led to statistically significant reductions in distress and impairment associated with UITs at post-intervention (controlled between-group d = 0.99, 95% CI 0.56 to 1.43), which were maintained at the 1-month follow-up (controlled between-group d = 0.90, 95% CI 0.41 to 1.39). The intervention was deemed to be feasible and acceptable by the participants. Change in negative appraisals mediated reductions in UITs but the model was sensitive to mediator-outcome confounders. We conclude that this novel online self-guided cognitive intervention can potentially reduce the distress and impairment associated with UITs in new parents. Large-scale trials are warranted. Abbreviations: UITs: Unwanted Intrusive Thoughts PTBC: Parental Thoughts and Behaviour Checklist. [ABSTRACT FROM AUTHOR]

Objective: Over the 2018-2019 flu season we conducted a randomized controlled trial examining the efficacy of a Twitter campaign on vaccination rates. Concurrently we investigated potential interactions between digital social network structure and vaccination status. Participants: Undergratuates at a large midwestern public university were randomly assigned to an intervention (n = 353) or control (n = 349) group. Methods: Vaccination data were collected via monthly surveys. Participant Twitter data were collected through the public-facing Twitter API. Intervention impact was assessed with logistic regression. Standard network science tools examined vaccination coverage over online social networks. Results: The campaign had no effect on vaccination outcome. Receiving a flu shot the prior year had a positive impact on participant vaccination. Evidence of an interaction between digital social network structure and vaccination status was detected. Conclusions: Social media campaigns may not be sufficient for increasing vaccination rates. There may be potential for social media campaigns that leverage network structure. [ABSTRACT FROM AUTHOR]

Current evidence has demonstrated that patients with Multiple Sclerosis (MS) have dysbiotic gut microbiomes, and anti-inflammatory nutritional interventions can normalize this status. Therefore, we aimed to investigate the effects of dietary intervention in patients with progressive forms of MS. Seventy patients with three forms of progressive MS (primary-progressive, secondary-progressive, and progressive-relapsing) were randomly assigned into intervention (daily synbiotics capsule plus anti-inflammatory-antioxidant rich diet) or control (placebo capsule plus dietary recommendations) groups for four months. Faecal calprotectin level, Impact of Vision Impairment (IVI), Gastrointestinal Symptom Rating Scale (GSRS), and anthropometric measurements were evaluated at baseline and trial cessation. Analysis of covariance was conducted and adjusted for age, gender, education level, family history & duration of MS, type of progressive MS, type of main drug, and physical activity. Sixty-nine participants were included in the final analysis (n of intervention = 34; n of control = 35). Synbiotics and dietary intervention significantly reduced Faecal calprotectin level after six months (110.5 ± 75.9–44.7 ± 49.3 ɥg/g, P < 0.001), and mean changes were statistically significant in comparison with control group. However, intervention did not elicit any change in the anthropometric measurements. Synbiotics supplementation and adherence to an anti-inflammatory-antioxidant-rich diet reduced intestinal inflammation and improved clinical manifestations in progressive forms of MS. Trial registration: Iranian Registry of Clinical Trials identifier: IRCT20141108019853N7.. [ABSTRACT FROM AUTHOR]

Abstract Objectives Method Results Conclusion The effects of oxytocin (OT) administration on psychotherapeutic processes have thus far been elusive. This study explored the effect of OT administration on patient-therapist congruence of the working alliance.Inpatients with mental disorders (N = 87) participating in a randomized controlled trial received OT (n = 44) or placebo (n = 43) intranasally twice a day, for four weeks. Patients and therapists rated the alliance after each session.Oxytocin significantly moderated the level of agreement (b = −0.56, SE = 0.25, t = −2.30, p = 0.02), such that patients receiving OT demonstrated lower discrepancy (b = −0.73, p < 0.001) than did those receiving placebo (b = −1.30, p < 0.001). On the other hand, the mutual covariance of patient-therapist ratings across sessions was positive and significant for patients receiving placebo (b = 0.26, p = 0.01) but not for patients in the OT group (b = −0.06, p = .56).Oxytocin can reduce discrepancies of patient-therapist perceptions of the alliance, although additional studies are needed to explore OT's effect on alliance development over time. As alliance congruence is associated with therapy outcomes, such intervention may lead to enhancement of therapeutic gains. [ABSTRACT FROM AUTHOR]

A history of traumatic life events is associated with chronic pain in later life. Physical therapists utilize a variety of methods to treat pain, however, they have struggled to find effective interventions to improve patient outcomes. To compare impairment-based, regional (REGION-PT) physical therapy (PT) to a global (GLOBAL-PT) model consisting of pain neuroscience education, graded motor imagery, and exercise for adults with chronic pain and history of trauma. Randomized Controlled Trial. Adults ≥ 18 years of age with chronic pain and a history of ≥1 trauma identified through the Life Events Checklist received the allocated intervention once a week for six weeks. Treatment effects were assessed using linear mixed models. Ninety-eight participants completed the trial. There were no difference in outcomes between groups. There were significant interactions between race and intervention. Both interventions were associated with improvements in pain interference for white participants, but non-white participants experienced improvement only with GLOBAL-PT. Regardless of allocation, participants improved in physical function, six of the PROMIS-29 domains, and in pain interference measures. Both interventions are reasonable strategies for individuals with chronic pain and a history of trauma. [ABSTRACT FROM AUTHOR]

To determine the effect of a 6-month traditional Chinese mind-body Baduanjin exercise intervention on cognitive ability in older people with Mild cognitive impairment (MCI). A total of 135 community-dwelling seniors with MCI were randomized into either the Baduanjin group (BDJ), the brisk walking group (BWK) or the usual physical activity control group (UPA). Cognitive ability was assessed at baseline, 2, 4 and 6 months post-intervention, and 3 months after the intervention ended. After 6 months of intervention, the MoCA score of the BDJ group was significantly higher than that of the UPA group (P < 0.05), The Go/No-go correct numbers of the BDJ group and BWK group were significantly higher than those of the UPA group (P < 0.05). There was no statistical difference in other outcomes, or there were only a tiny effect size. Three months after the intervention, there was no significant difference between the primary and secondary outcomes(P > 0.05). The 6-month period of Baduanjin training has positive benefits on global cognitive function and attention function in community-dwelling elderly individuals with MCI. The effect seems to have been transient and needs to be confirmed by additional studies. [ABSTRACT FROM AUTHOR]

Online interventions that elicit kindness may enhance well-being. We tested the efficacy of three kindness interventions among breast cancer survivors. Participants (N = 137, Mage = 62.65 years) were randomized to perform acts of kindness for others, acts of kindness for self, self-kindness meditation, or a daily-activities-writing control and completed three activities each week for 4 weeks. Primary (well-being, depressive symptoms) and secondary outcomes (social support, self-kindness) were assessed pre- and post-intervention. No differences emerged in the primary outcomes. However, relative to controls, participants in the acts of kindness to others condition reported greater increases in social support, and participants in the self-kindness meditation condition reported greater decreases in self-kindness. Among breast cancer survivors, performing prosocial acts may enhance feelings of social support. The two self-kindness conditions yielded either null or detrimental effects, suggesting that further research is needed on best practices for conducting self-focused kindness interventions. [ABSTRACT FROM AUTHOR]

To determine the efficacy of the "Training for Occupational health physicians To Involve Significant others" (TOTIS) e-learning module for improving occupational health physicians' (OHPs) knowledge, attitudes, and self-efficacy regarding involving significant others in the return-to-work process. A randomized controlled trial with 87 OHPs, involving an intervention group and a wait-listed control group. Between-group differences in knowledge, attitude, and self-efficacy outcomes, and retention of effects were assessed using ANOVA and paired t-tests. Reactions to the e-learning module were analyzed with descriptive statistics and thematic analysis. We found moderate to large effects on OHPs' knowledge (p < 0.001, ηp2 = 0.202), attitudes (p = 0.003, ηp2 = 0.098), and self-efficacy (p < 0.001, ηp2 = 0.237), with retention of all changes at 10-week follow-up. OHPs graded the e-learning module with a mean score of 7.9 out of 10 (SD = 1.11) and indicated that the module increased their awareness of the role of significant others and encouraged them to address this more often. The TOTIS e-learning module and accompanying materials are valuable resources for OHPs to learn how significant others influence work outcomes of workers with chronic diseases and to manage their involvement in the re-integration process. This study is registered in the Netherlands Trial Register under trial number NL8744; . The TOTIS e-learning module is the first evidence-based training to improve the knowledge, attitudes, and self-efficacy of occupational health physicians with regard to involving significant others in the re-integration process of workers with chronic diseases. The e-learning module and accompanying tools can increase the awareness of occupational health physicians about the role of significant others and encourage them to address the role of significant others in the re-integration process of sick-listed workers. It could be beneficial to expand on the e-learning module with a face-to-face training program involving group interaction, peer discussion, and skills development. [ABSTRACT FROM AUTHOR]

Satisfaction from police performance in cases that are screened out from police investigation is low, particularly for victims who report online. In a randomized controlled trial, we report the impact of reassurance telephone callbacks on satisfaction scores for victims of vehicle crime in London, United Kingdom. Evidence suggests that reassurance callbacks cause victims to express more favorable attitudes toward the police, with more pronounced satisfaction scores among minority victims, particularly those who report their crime online. We argue that callbacks to victims are advantageous in an era of a police legitimacy crisis with diminished resources for law enforcement. [ABSTRACT FROM AUTHOR]

A randomized controlled trial was conducted to study the effectiveness of two readers' theater (RT) programs in promoting reading skills and motivation of dysfluent readers in Grades 3–4. One program (RT Goal) included a goal of preparing a performance for an audience (n = 50), while another program (RT Practice) did not include such a goal (n = 49). A group of dysfluent readers receiving traditional oral reading intervention (Control group; n = 59) and a group of classroom peers (Mainstream group; n = 159) served as controls. The results indicate that both RT groups and the Control group developed at a higher rate in oral reading speed during the intervention period than the Mainstream group. The RT Goal program was associated with higher engagement ratings and a temporary reduction in reading errors and oral reading anxiety. RT had no effects on silent reading skills or reading self-efficacy. [ABSTRACT FROM AUTHOR]

The results of treatment effect of vitamin or antioxidant intake on diabetic peripheral neuropathy (DPN) was inconsistent. Therefore, we performed a meta-analysis of randomized controlled trials (RCTs) to examine whether these supplements are effective in DPN treatment. We searched seven databases from inception to October 2021. All RCTs of DPN treatments with vitamin and antioxidant supplements were included. We performed sensitivity and subgroup analysis, and also tested for publication bias by the funnel plot and Egger's test. A total of 14 studies with 1384 patients were included in this systematic review. Three high-quality trials showed that vitamin and antioxidant supplements significantly increased sensory nerve conduction velocity (SNCV) of the sural nerve (MD = 2.66, 95%CI (0.60, 4.72), P < 0.05, I2 = 0%). Seven studies (758 participants) suggested that these supplements might have improvement on motor nerve conduction velocity (MNCV) of the peroneal nerve in DPN patients with the random-effect model (MD = 0.60, 95%CI (0.28, 0.92), P < 0.05, I2 = 65%). In four studies, these supplements could have improved on MNCV of the median nerve with the fixed-effect model (MD = 4.22, 95%CI (2.86, 5.57), P < 0.05, I2 = 0%). However, ten studies (841 participants) have suggested that vitamin and antioxidant supplements have not decreased glycosylated haemoglobin (HbA1c). Vitamin and antioxidant supplements may improve the conduction velocity of nerves, including median, sural and peroneal nerves of patients with DPN. But these supplements have not decreased HbA1c in DPN patients. Several trials with a large sample size are needed to provide evidence support for clinical practice in the future. [ABSTRACT FROM AUTHOR]

Abstract Although designed to prepare students for future coursework or to fulfill basic degree requirements, introductory math courses often serve as barriers to student success. In two double-blind randomized field experiments, we tested the efficacy of a utility-value intervention on improving community college students’ perceived math relevance and achievement in introductory math courses. Building upon prior research, we examined whether the intervention particularly benefited first-generation and racially marginalized students. Study 1 (N = 696) was conducted before the COVID-19 pandemic and within in-person classrooms, whereas Study 2 (N = 1,318) was conducted during the pandemic and within virtual learning environments. Across Studies 1 and 2, students in the utility-value condition benefited more in terms of their perceived relevance compared to their peers in the control condition. Additionally, in both studies, math relevance mediated the effects of the intervention on math grades. In Study 2, with a larger sample, the positive effect of the intervention on math relevance was more pronounced for first-generation students. Our findings imply that community colleges could significantly improve students’ academic experiences by investing in motivation-enhancing activities such as utility-value interventions in introductory math courses. This strategy could especially help first-generation students’ academic achievement and retention rates. [ABSTRACT FROM AUTHOR]

Abstract Purpose Materials and Methods Results Conclusion \nIMPLICATIONS FOR REHABILITATION The study aimed to compare the effectiveness of a traditional cardiac rehabilitation (CR) program with an enhanced program incorporating the model of therapeutic engagement (MTE) and extended remote support for patients undergoing coronary artery bypass graft (CABG) patients.In a randomized controlled trial, 88 CABG patients were assigned to experimental and control groups. The experimental group received integrated MTE cardiac rehabilitation, and assessments were conducted at three time points: pre-CR, one month later, and three months post-CR. The study measured medication adherence (MARS-5) and sense of coherence (SoC-13) scales.The study found no significant differences in demographic factors between the experimental and control groups. However, significant differences were observed in MARS and individuals’ SoC scores over time in the experimental group, with notable improvements (p < 0.001). The control group showed significant changes only up to one month. Group effects were evident, with consistent increases in the experimental group’s outcomes at each assessment point.Integrating the MTE into CR programs offers benefits in terms of medication adherence and individuals’ sense of coherence, which warrants further investigation and clinical implementation. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs). This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program. The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes. This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. Cardiac rehabilitation (CR) is recognized as one of the most effective interventions for secondary prevention, but its accessibility is limited in middle-income countries (MICs).This study represents one of the first theoretically-informed CR trials in a MIC that incorporates the model of therapeutic engagement (MTE) combined with extended remote support services into CR program.The MTE model, as a theoretical framework, was highly suitable for CR settings and demonstrated favorable outcomes.This approach has the potential to greatly benefit cardiac patients, particularly those who may initially show hesitance or reluctance towards engaging in CR. [ABSTRACT FROM AUTHOR]

Diagnosis and treatment of childhood brain tumor have detrimental effects on physical, neurocognitive, psychological, and social functioning that lasts into adulthood and effects quality of life (QOL). To address diminished QOL, an Internet-based behavioral activation (BA) intervention was developed. Behavioral activation aims to increase activities and behaviors likely to improve thoughts, mood, and QOL. Participants included 127 young adult survivors of childhood brain tumor (SCBT) randomized into the experimental group (n= 64) or the waitlist control group (n= 63). The dependent variables included: life satisfaction, stress, and activation and were assessed with a two-way mixed analysis of variance (ANOVA). Results revealed a significant interaction between the intervention and time on life satisfaction, F(1, 125)=4.793, p = 0.03. There were no significant main effects over time for perceived stress and activation. Findings offer initial evidence that BA can be delivered over the internet and that Internet-delivered BA can have a positive effect on the QOL of young adult SCBT. Internet-based BA interventions can serve as a resource for young adult SCBT who desire to boost their mood and QOL. Behavioral activation (BA) is aimed at increasing positively reinforcing overt behaviors that are likely to promote improved thoughts, mood, and quality of life (QOL). Results indicated study participants in the experimental group demonstrated a significant gain in life satisfaction compared to the control group after receiving the Internet-based BA intervention; and provides support that the intervention was associated with positive changes across time. Findings offer initial evidence that BA can be delivered over the internet and that Internet-delivered BA can have a positive effect on the QOL of young adult survivors of childhood brain tumor (SCBT). Internet-based BA interventions can serve as a resource for young adult SCBT who desire to boost their mood and QOL. [ABSTRACT FROM AUTHOR]

Asthma is known as one of the most common chronic inflammatory diseases characterized by recurrent obstruction and inflammation of the airways. Probiotics are defined as a group of beneficial living microorganisms that are beneficial in many disorders, including allergies. The aim of this study was to investigate the probiotic supplement effects on improvement of clinical asthma symptom and changes in the pattern of Th17-related inflammatory cytokines in asthmatic patients. This was a randomized controlled clinical trial with parallel, double-blind groups. Forty patients with asthma were enrolled and received 1 capsule/day of a probiotic supplement for 8 weeks. Respiratory function tests; and the level of IL-6, IL-17, IL-21 and TGF-β were evaluated at the baseline and end of intervention. The results showed that the level of IL-6 and IL-17 in patients after receiving probiotics was reduced and expression of TGF-β was increased as compared to the baseline. Also, the expression of IL-17 and IL-21 in the probiotic group was significantly lower than the placebo group at the end of the intervention. In addition, an improvement in pulmonary function tests and clinical symptoms was observed after receiving probiotics. Eight-weeks treatment with a probiotic supplementation suggests that it may effect on Th17 cells-associated IL-6, IL-17 and TGF-β; and Forced Expiratory Volume in 1 s and Forced Vital Capacity. Taken together, these results suggest that probiotics may have the ability to affect neutrophilic asthma and they can possibly be used besides common treatments for patients with neutrophilic asthma. [ABSTRACT FROM AUTHOR]

Children with ADHD show impairments in set shifting task performance. However, the limited available evidence suggests that directly training shifting may not improve shifting performance in this population. We hypothesized that this incongruence may be because impairments exhibited by children with ADHD during shifting tasks are due to deficits in other executive functions, as shifting tasks also engage children's working memory and/or inhibitory control abilities. This randomized controlled trial examined the extent to which neurocognitive training of working memory vs. inhibitory control can produce downstream (far-transfer) improvements in set shifting task performance. Children with ADHD ages 8–12 (M = 10.41, SD = 1.46; 12 girls; 74% White/Non-Hispanic) were randomized to either central executive training (CET; n = 25) or inhibitory control training (ICT; n = 29), two next-generation digital therapeutics previously shown to improve their intended neurocognitive targets. Two criterion set shifting tests were administered at pre- and post-treatment. Results indicated that ICT was superior to CET for improving shifting accuracy (treatmentxtime: p =.03, BF10 = 3.01, η2 =.09, d = 0.63). ICT was also superior to CET for improving shifting speed, albeit on only one of the two outcome tasks (p =.02, BF10 = 4.53, η2 =.08, d = 0.59). CET did not produce improvements in shifting speed or accuracy on either task (p >.52, BF01 > 2.62), but showed evidence for more general (non-shifting-specific) improvement in response times on one of the outcome tasks (shift trials, d = 0.70; non-shift trials, d = 0.68). Taken together, these findings confirm that inhibitory control is important for successful performance on shifting tests, and suggest that training inhibitory control may reflect a method for improving set shifting difficulties in children with ADHD. [ABSTRACT FROM AUTHOR]

This randomized controlled trial examined the effects of fictive kin interaction on the physical health and psychological well-being of older adults living in a shared site nursing home in China. The results revealed that depression levels significantly decreased and self-efficacy and flourishing levels significantly increased among the participants who engaged in additional one-to-one pair activities with kindergartners, with the effect size ranging from medium to large. The research findings indicated that one-to-one fictive kinship interactions between older adults and young children can promote the self-perceived physical health and psychological well-being of older adults in a Chinese context. [ABSTRACT FROM AUTHOR]

A major focus of HF palliative care is to reduce symptom burden, yet managing HF symptoms is complex and requires adequate problem-solving skills. Telehealth interventions that provide support and problem-solving training may enhance symptom management and reduce symptom distress. The purpose of this study was to examine the preliminary effectiveness of the Coping in Heart Failure (COPE-HF) Partnership telehealth intervention (ClinicalTrials.gov Identifier: NCT05337293) on HF symptom frequency, severity, and symptom-related degree of interference with physical activity and enjoyment of life. This was a three-group randomized controlled pilot study. The intervention group received one home visit and weekly (first month), then biweekly (months 2, 3) telephone calls. The attention group received a sham intervention on a similar schedule. The control group received usual care. The Heart Failure Symptom Survey was administered at baseline, 5, 9, and 13 weeks. Linear mixed modeling with restricted maximum likelihood estimation examined intervention effects on study outcomes. Of 107 enrolled participants, 66 completed the study. Participants were 61 years old; 56% non-Caucasian; and 54.2% male. Significant improvement in total HF symptoms and all sub-scales from baseline to 13 weeks were noted in the intervention group, with the largest improvement seen in HF symptom severity (md = −2.59, <0.001, 95% CI [−3.65, −1.53]). Providing support and tailored problem-solving training as a component of palliative care may empower patients to develop strategies to manage bothersome symptoms, thereby decreasing symptom severity. However, more research is needed to examine this intervention in a larger sample. Trial registration: ClinicalTrials.gov identifier: NCT05337293. [ABSTRACT FROM AUTHOR]

Randomized Controlled Trials (RCTs) are currently considered 'gold standard' for evaluating psychosocial interventions, including psychodynamic psychotherapies (PDTs). The aim of this review is to summarize all available RCTs involving PDTs. A thorough search yielded 298 studies published between 1967 and 2022. The number of studies has increased over time with 123 (41.2%) published in the last 10 years. Most studies have been conducted in western countries, evaluating PDTs of brief duration (<40 sessions) for adults with mood (k = 67, 22.5%), psychosomatic (k = 38, 12.8%), anxiety (k = 35, 11.7%), or personality disorders (k = 29, 9.7%). The studies have utilized comparative (k = 233, 78.2%), additive (k = 33, 11.1%), parametric (k = 30, 10.1%) and dismantling designs (k = 2, 0.7%) and includes a total of 374 comparisons. Categorization of outcomes suggests that PDTs typically outperforms inactive controls, while comparisons with active treatments, inclugding Cognitive-Behavior Therapy (CBT), typically indicate no statistical difference. While the evidence-base for PDTs is growing, there are still major limitations and many research questions yet to be addressed. There is a pressing need for disseminating the existing research for PDTs to policy makers and the general public, as well as integrating findings in psychodynamic training curriculums. [ABSTRACT FROM AUTHOR]

Objective: Randomized double-blind placebo-controlled trial was conducted with sixty pregnant women to evaluate the effect of antenatal omega-3 supplementation on maternal depressive symptoms from pregnancy to 6 months postpartum. Methods: Participants with gestational age between 22 and 24 weeks were randomized in placebo (olive oil; n = 30) or omega-3 (fish oil; n = 30) groups and supplemented until childbirth. Fish oil capsules provided 1440 mg/day of docosahexaenoic acid. Depressive symptoms were evaluated during the gestational period: (G1) 22–24 weeks; (G2) 26–28 weeks; (G3) 30–32 weeks; (G4) 34–36 weeks; and postpartum: (P1) second week; (P2) first month; (P3) fourth month; and (P4) sixth month, using the Edinburgh Postnatal Depression Scale (EPDS). Intention-to-treat and per-protocol analyses were performed using Generalized Estimating Equations (GEE). Results: Comparison between groups showed no differences in the EPDS score at any time during pregnancy or postpartum, in both intention-to-treat and per-protocol analysis (p > 0.05). Both groups presented a reduction in the EPDS score over time. According to intention-to-treat analysis, when comparing to the baseline, the placebo group showed a reduction in the EPDS score at P1 and P4, while the omega-3 group showed a reduction at all times from G4 to P4. In per-protocol analysis, the placebo group showed a reduction in the EPDS score at P3, while the omega-3 group showed a reduction at all times from G2 to P4. Conclusions: The supplementation with omega-3 did not promote significant differences between groups. However, an earlier reduction in the EPDS score was observed in the omega-3 group, which may indicate a benefit of antenatal omega-3 supplementation. [ABSTRACT FROM AUTHOR]

Cognitive stimulation is a recommended therapy with positive effects on the cognitive performance of older adults with neurocognitive disorders. However, there are few one-on-one, long-term interventions applied by professionals. The aim of the present study was to determine the effectiveness of 47-week individual cognitive stimulation (iCS) interventions on cognition, mood, instrumental activities of daily living, and quality of life in older adults, with neurocognitive disorders using a single-blind, randomized, parallel two-arm RCT. A sample of 59 older adults with neurocognitive disorders (predominantly Alzheimer's disease), who were non-institutionalized but socially vulnerable, was selected. The intervention group (n = 30) received 47 iCS weekly sessions. The control group (n = 29) maintained their baseline treatments. Outcomes were global cognitive function, cognitive impairment, mood, instrumental activities of daily living, and self-reported quality of life. All participants were assessed at baseline, 25 weeks, and 50 weeks. The results showed a significant effect of the intervention on MMSE, MoCA, GDS-15. Individual cognitive stimulation may have beneficial effects on the cognitive function and mood of older adults with cognitive impairment. [ABSTRACT FROM AUTHOR]

To examine the effects of ride-on car (ROC) training using different postures on mobility and social function in children with motor delays in comparison with conventional therapy. Thirty-eight children (22 males, 16 females) with motor delays were recruited and randomly assigned to three groups: ROC training while sitting (ROC-Sit, n = 15; mean age, 20.25 months; standard deviation [SD], 5.29), ROC training while standing (ROC-Stand, n = 12; mean age, 24.80 months; SD, 8.42), and conventional therapy (control, n = 11; mean age: 20.25 months, SD: 5.37). All groups underwent 2-h training sessions twice weekly over a 12-week intervention phase. The Pediatric Evaluation of Disability Inventory and Goal Attainment Scaling were performed before and after the intervention and at follow-up sessions after 12 weeks. Mobility and goal achievement improved significantly in all groups after the intervention (p < 0.001; p < 0.0001). However, social function improved significantly only in the ROC-Stand group (p = 0.001), which had the highest number of participants showing clinically meaningful changes in mobility and social function. Increased practice and caregivers' involvement can improve children's mobility and goal achievement. Adopting a standing posture in an ROC can enhance social function. Providing active exploratory experience through ride-on cars or practicing specific skills can improve children's mobility function. Ride-on car training in a standing posture allows children to access their distal environment visually, resulting in improved social function. Setting goals with caregivers maximizes the effects of treatment on goal achievement. [ABSTRACT FROM AUTHOR]

We conduct a randomized controlled trial (RCT) to explore whether providing tourists with information about the weather conditions in the destination country has a positive impact on their satisfaction level. We show that providing accurate weather information enables tourists to form more correct expectations i.e. closer to the actual weather conditions in the destination country – which in turn improves their satisfaction and makes them more likely to recommend relatives and friends to make the same trip. These findings reveal the role of information provision in improving tourists’ satisfaction. Finally, our study encourages the application of the RCT approach as it addresses interesting questions in tourism research. [ABSTRACT FROM AUTHOR]