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Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Recently, dance has become a therapeutic and rehabilitative intervention for individuals with Parkinson's disease (PD). Compared with traditional gait training or other rehabilitative interventions, dance appears to be a safe, fun, and an alternative way to achieve functional changes and improvements in mobility, gait, balance, and quality of life. This paper reviews literature regarding dance and PD in terms of enrollment size, dosage and frequency of intervention, class size, comparison or control groups, outcome measures, and effect size. A search was conducted on PubMed, Web of Sciences, Cochrane Library, and Google Scholar using the terms 'dance' and 'Parkinson's disease.' Ten papers were included in this review: seven of which examined walking speed, nine that included measures of balance, one study that examined upper extremity function, eight studies that measured disability rating, and one study that examined falls. Only five studies had control groups, three of which were active control groups. Various studies have clinical design issues such as inclusion of a control group, outcome measures or the way in which the intervention was administered. Essential outcome measures to include are safety, tolerability, quality of life, and falls. These measures determine information on treatment effects, adverse event rates, and dropout rates. [ABSTRACT FROM AUTHOR]

Background: Palmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training. Methods: The primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition. Results: 48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes. Conclusion: PEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p). Key Findings: Palmitoylethanolamide (PEA) is a compound that works as an anti-inflammatory and analgesic for the management of pain that works on different biochemical pathways compared to other over-the-counter analgesics and non-steroidal anti-inflammatories. Our findings indicate that a daily dose of 300 mg of PEA administered during 8-weeks of strength training did not interfere with skeletal muscle hypertrophy gains and may improve lower body power (e.g., jump height) compared to the placebo group. PEA may fill the gap for athletes and the active population as an alternative method of pain management. [ABSTRACT FROM AUTHOR]

Purpose A multifaceted implementation strategy was targeted at supervisors to encourage them to apply a participatory approach (PA) in dealing with employees' work functioning problems due to health concerns. This paper assesses the effect on employees' perceived social norms regarding the use of the PA to deal with work functioning problems. Methods Three organizations participated in a cluster randomized controlled trial, with randomization at the department level. Supervisors in the PA intervention departments received the implementation strategy consisting of a working group meeting, supervisor training, and optional coaching. Supervisors in the control departments received written information about the PA only. In two of the organizations, employees were invited to complete surveys at baseline and at 6-month follow-up. The primary outcome was perceived social norms regarding the use of the PA to deal with work functioning problems. Secondary measures included attitudes and self-efficacy, and intention regarding joint problem solving, and sick leave data. Effects were analyzed using multilevel analyses to account for nesting of cases. Results At baseline, 273 employees participated in the survey, with follow-up analyses of 174 employees. There were no statistically significant group effects on employee outcome measures. The intervention group showed a larger reduction in mean sick days (from 4.6 to 2.4 days) versus the control group (from 3.8 to 3.6 days), but this difference did not reach statistical significance ( p > .05). Conclusion The multifaceted strategy to implement the participatory approach for supervisors did not show effects on outcomes at the employee level. To gain significant effects at the employee level, may require that an implementation strategy not only targets management and supervisors, but also employees themselves. Trial registration: NTR3733. [ABSTRACT FROM AUTHOR]

Background: Psychological distress is highly noticeable among caregivers working in residential youth care (RYC). Maintaining and enhancing caregivers' professional mental health and quality of life is crucial to achieve effective outcomes in RYC. Nevertheless, trainings to protect caregivers' mental health are scarce. Considering the buffering effect over negative psychological outcomes, compassion training could be beneficial in RYC. Objective: This study is part of a Cluster Randomized Trial examining the effects of the Compassionate Mind Training for Caregivers (CMT-Care Homes), looking at professional quality of life and mental health of caregivers working in RYC. Method: The sample was composed of 127 professional caregivers from 12 Portuguese residential care homes (RCH). RCHs were randomly allocated at experimental (N = 6) and control group (N = 6). Participants were assessed at baseline, post-treatment, and 3 and 6-month follow-ups, answering to the Professional Quality of Life Scale and the Depression, Anxiety and Stress Scale. Program effects were tested using a two-factor mixed MANCOVA, with self-critical attitude and education degree as covariates. Results: MANCOVA showed a significant Time × Group interaction effects (F = 1.890, p =.014; η p 2 =.050), with CMT-Care Homes participants presenting lower scores on burnout, anxiety, and depression at 3 and 6-months follow-ups, when compared with controls. Participants that received CMT-Care Homes considered the program useful to deal with pandemic threats and with youth during lockdowns. Conclusion: This study shows the benefits of the CMT-Care Homes in helping professional caregivers reducing burnout, anxiety and depression, and dealing with pandemic challenges in RYC. Trial registration: This cluster randomized trial was registered at ClinicalTrials.gov (TRN: NCT04512092) on 6th August 2020. [ABSTRACT FROM AUTHOR]

This study examined the effectiveness of a theory-based mHealth intervention on the quality of life (QOL) of people living with HIV. A randomized controlled trial was performed at two outpatient clinics in Hanoi, Vietnam. There were 428 patients with HIV/AIDs in selected clinics and were divided into the intervention arm (receiving HIV-assisted smartphone application and usual care) and the control arm (receiving only usual care). The WHOQOLHIV-BREF instrument was utilized to measure QOL. An intention-to-treat approach using Generalized Linear Mixed Model analysis was performed. The trial showed significant improvements in Physical health, Psychological health, and Level of Dependence among patients in the intervention arm compared to the control arm. However, the Environment and Spirituality/Personal beliefs improvements would require additional interventions, both individual, organizational, or governmental. This study explored the utility of a smartphone mobile application for individuals with HIV, and how the resultant application could improve the overall QOL. [ABSTRACT FROM AUTHOR]

Backgrounds and Objectives: The use of anti-inflammatory supplements is important in improving the executive function of obese people. This research aims to investigate the effect of 6 weeks of aerobic exercise with moderate intensity as well as the consumption of nanocurcumin on IL1β, nitric oxide (NO), and depression in women aged 60–65 with metabolic syndrome. Materials and Methods: Fourty-four women with metabolic syndrome were randomly selected and divided into four groups of 10 based on their use of nanocurcumin supplement. The treatment included the training (T), nanocurcumin (N), training + nanocurcumin (TN), and the control groups. The groups exposed to training performed aerobic exercise for 6 weeks (three sessions per week). Blood samples were obtained before and after the training period for antioxidant indicators and lipid degradation measurement. Also, the Beck anxiety questionnaire was used for evaluating levels of anxiety. T-test and one-way analysis of variance (ANOVA) tests were used for the assessment of within-group and between-group differences, respectively. Results: There was a significant difference in IL1β, NO, and depression before and after exercise in all three experimental groups (p ≤ 0.05). Also, the results showed a significant difference in the level of NO and depression in the experimental groups. The highest decrease in these variables was observed in the T and TN groups (p ≤ 0.05). Conclusion: These findings indicated that 6-week nanocurcumin supplementation with aerobic training is a suitable method for reducing IL1β, NO, and depression, preventing metabolic, cardiovascular, and inflammatory diseases in women with metabolic syndrome. Name of the registry: IR.SEMUMS.REC.1396.107 Trial registration number: IRCT2017082335857N1 [ABSTRACT FROM AUTHOR]

Background: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity. Methods: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity. Results: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005). Conclusion: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Perinatal depression is common among women living with HIV, but depression care is limited in low-resource settings. We examined (1) characteristics of women receiving Problem Solving Therapy (PST) versus antidepressant therapy (ADT), (2) treatment response by modality, and (3) correlates of treatment response. Methods: This analysis used data from 191 Ugandan women in the intervention arm of a cluster randomized controlled trial of task-shifted, stepped-care depression treatment for pregnant women living with HIV (PWLWH). Treatment response was defined as scoring < 5 on the nine-item Patient Health Questionnaire (PHQ-9). Bivariate analysis and multivariable logistic regression were used to examine characteristics of women by treatment group and correlates of treatment response. Results: Of 134 participants with depression, 129 (96%) were treated: 84 (65%) received PST and 45 (35%) received ADT. Severe depression at treatment initiation was more common in those receiving ADT (28.9% versus 4.8%, Fischer's Exact Test < 0.001). Treatment response was higher for PST (70/84; 83.3%) than ADT (30/45; 66.7%; p =.03). ADT side effects were rare and minor; no infants had serious congenital defects. Of 22 participants (19%) who did not respond to treatment, only five received intensified management. Social support and interpersonal violence were associated with treatment response (adjusted odds ratio, [aOR] = 3.06, 95% CI = 1.08–8.66 and aOR = 0.64, 95% CI = 0.44–0.93). Discussion: Both depression treatment modalities yielded high response rates in Ugandan PWLWH; ADT was well-tolerated. Our results highlight a need to build capacity to implement the stepped-care protocol for non-responders and screen for social support and interpersonal violence. Significance: What is Already Known on this Subject?Prior research has demonstrated the feasibility and effectiveness of delivering collaborative care for depression in low-resource settings including Uganda. What this Study adds?Both Problem-Solving Therapy and antidepressant therapy yielded high treatment response rates among pregnant women living with HIV in Uganda who met criteria for depression, and antidepressant therapy was well tolerated. This study highlights a need to build capacity to implement the task-shifted stepped-care protocol for women whose depression does not respond to initial treatment, and to screen for social support and interpersonal violence. [ABSTRACT FROM AUTHOR]

To address the unmet need for scalable solutions for lifestyle treatment, we developed a new digital method to promote behavioral change. Here we report that patients with type-2 diabetes in Sweden (n = 331) exposed to the intervention have significantly improved HbA1c during a median follow-up of 1038 days (4 mmol/mol compared with matched controls; P = 0.009). This is paralleled by reduced body weight, ameliorated insulin secretion, increased physical activity, and cognitive eating restraints. Participants with high BMI and insulin resistance have an even larger response, as have non-risk allele carriers for the FTO gene. The findings open a new avenue for scalable lifestyle management with sustained efficacy and highlight a previously unrecognized opportunity for digital precision treatment based on genetics and individual pathophysiology. ClinicalTrials.gov NCT04624321. [ABSTRACT FROM AUTHOR]

Congenital malformations of the central nervous system are among the most common major congenital malformations. Deep learning systems have come to the fore in prenatal diagnosis of congenital malformation, but the impact of deep learning-assisted detection of congenital intracranial malformations from fetal neurosonographic images has not been evaluated. Here we report a three-way crossover, randomized control trial (Trial Registration: ChiCTR2100048233) that assesses the efficacy of a deep learning system, the Prenatal Ultrasound Diagnosis Artificial Intelligence Conduct System (PAICS), in assisting fetal intracranial malformation detection. A total of 709 fetal neurosonographic images/videos are read interactively by 36 sonologists of different expertise levels in three reading modes: unassisted mode (without PAICS assistance), concurrent mode (using PAICS at the beginning of the assessment) and second mode (using PAICS after a fully unaided interpretation). Aided by PAICS, the average accuracy of the unassisted mode (73%) is increased by the concurrent mode (80%; P < 0.001) and the second mode (82%; P < 0.001). Correspondingly, the AUC is increased from 0.85 to 0.89 and to 0.90, respectively (P < 0.001 for all). The median read time per data is slightly increased in concurrent mode but substantially prolonged in the second mode, from 6 s to 7 s and to 11 s (P < 0.001 for all). In conclusion, PAICS in both concurrent and second modes has the potential to improve sonologists' performance in detecting fetal intracranial malformations from neurosonographic data. PAICS is more efficient when used concurrently for all readers. [ABSTRACT FROM AUTHOR]

Background: The COMET-ICE trial demonstrated that sotrovimab clinically and statistically significantly reduces the risk of all-cause > 24-h hospitalization or death due to any cause among patients with COVID-19 at high risk of disease progression. Patient-reported outcomes are important to capture symptom burden of COVID-19 and assess treatment effectiveness. This study investigated symptoms and their impact over the acute phase of COVID-19 infection among patients on sotrovimab versus placebo. Methods: Randomized (1:1), double-blind, multicenter, placebo-controlled, phase 2/3 study in 57 centers across five countries. Participants were non-hospitalized patients with symptomatic, mild-to-moderate COVID-19 and ≥ 1 baseline risk factor for disease progression (aged ≥ 55 years or ≥ 1 of the following: diabetes requiring medication, obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate-to-severe asthma). An intravenous infusion of sotrovimab 500 mg or placebo was administered on Day 1. The FLU-PRO Plus questionnaire was administered once-daily with 24-h recall from Day 1–21, and at Day 29. Intensity and duration of COVID-19 symptoms were determined from area under the curve (AUC) and mean change in total and individual domain scores through Days 7, 14, and 21. Time to symptom alleviation was assessed. Results: In total, 1057 patients were randomized to sotrovimab (n = 528) or placebo (n = 529). At Day 7, mean decrease in FLU-PRO Plus total score (measured by AUC) was statistically significantly greater for patients on sotrovimab (–3.05 [95% confidence interval (CI) –3.27 to –2.83]) than placebo (–1.98 [95% CI –2.20 to –1.76]; difference –1.07 [95% CI –1.38 to –0.76]; p < 0.001). Significant differences were also observed at Days 14 and 21. A more rapid decline in symptom severity was observed with sotrovimab versus placebo through Week 1 and the first 21 days post-treatment. By Day 21, 41% of patients on sotrovimab and 34% on placebo reported symptom resolution. In a post-hoc analysis, median time to symptom alleviation was 4 and 6 days, respectively. Conclusions: Sotrovimab provides significant and rapid improvements in patient-reported COVID-19 symptoms, as measured by the FLU-PRO Plus. These results further show the benefits of sotrovimab in alleviating symptoms among high-risk patients with COVID-19. Trial registration ClinicalTrials.Gov: NCT04545060 (https://clinicaltrials.gov/ct2/show/NCT04545060). Date of registration: September 10, 2020 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Objectives: Technology-based outreach offers promise for providing support to a broad population of postpartum mothers while keeping costs low. However, research on the efficacy of this approach is scarce. We conducted a pre-registered randomized pilot trial of the effects of a novel technology-based approach for supporting postpartum mothers – via text-based mentoring – from infant's birth through 18 months. Methods: Mothers (n = 201) were recruited at West Penn Hospital in Pittsburgh, PA in the days immediately following delivery. Treatment mothers were matched with volunteer mentors who communicated with them entirely via text messages. Control mothers received monthly one-way texts on basic safety topics. Measures were collected via hospital records and mother surveys. We estimated treatment effects on mothers' parenting stress, mental health, knowledge of child development, engagement in language and literacy activities, and child milestones at 4- and 18-months postpartum. We used a systematic coding approach and simple descriptive statistics to analyze the treatment mother-mentor texting transcripts. Results: We found no statistically significant impacts on targeted outcomes. However, impacts for some outcomes were meaningfully large (> 0.2 SDs). Analyses of texting transcripts showed that most mothers stayed engaged for the full 18-month study period and that mother-mentor pairs primarily discussed maternal wellbeing and child-focused topics. Conclusions for Practice: Postpartum mothers will engage with mentors in a text-based mentoring program around important maternal and child health topics. More research and development on technology-based supports for parents in the early childhood years is needed. Significance: What is already known on this subject? Technology-based approaches to supporting parents of young children are proliferating, with some showing promise in rigorous trials. What this study adds? Postpartum mothers will engage with mentors in text-based format and discuss maternal and child health topics. The efficacy of this approach should be tested further in larger trials. [ABSTRACT FROM AUTHOR]

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Childhood sexual and physical abuse have been linked to adolescent and adult risky sexual behaviors, including early sexual debut, an increased number of sexual partners, unprotected sex, alcohol and drug use during sex and sexual violence. This paper explores these relationships among both men and women who report histories of childhood abuse from representative samples of communities in three countries in southern and eastern Africa (South Africa, Zimbabwe and Tanzania). Data were collected as part of a 3-year randomized community trial to rapidly increase knowledge of HIV status and to promote community responses through mobilisation, mobile testing, provision of same-day HIV test results and post-test support for HIV. The results indicate that reported childhood sexual and physical abuse is high in all three settings, also among men, and shows strong relationships with a range of sexual risk behaviors, including age at first sex (OR −0.6 (CI: −0.9, −0.4, p < 0.003)-among men, OR −0.7 (CI: −0.9, −0.5, p < 0.001)-among women), alcohol (OR 1.43 (CI: 1.22, 1.68, p < 0.001)-men, OR 1.83 (CI: 1.50, 2.24, p < 0.001)-women) and drug use (OR 1.65 (CI: 1.38, 1.97, p < 0.001)-men, OR 3.14 (CI: 1.95, 5.05, p < 0.001)-women) and two forms of partner violence-recent forced sex (OR 2.22 (CI: 1.66, 2.95, p < 0.001)-men, OR 2.76 (CI: 2.09, 3.64, p < 0.001)-women) and ever being hurt by a partner (OR 3.88 (CI: 2.84, 5.29, p < 0.001)-men, OR 3.06 (CI: 2.48, 3.76, p < 0.001)-women). Individuals abused in childhood comprise between 6 and 29 % of young adult men and women living in these African settings and constitute a population at high risk of HIV infection. [ABSTRACT FROM AUTHOR]

Summary: We have developed a short, patient-reported outcome questionnaire-the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF)-that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. Introduction: This paper describes the development of the Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. Methods: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. Results: Item response theory-based analysis of OPAQ v.2.0 ( n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. Conclusions: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture. [ABSTRACT FROM AUTHOR]

A transdisciplinary approach incorporating biological, psychological, behavioral, and genetic factors was taken to better identify proposed moderators of the effectiveness of an intervention to increase physical activity. This paper illustrates how theory-based individual difference variables can be integrated into a complex randomized controlled trial. The transdisciplinary framework guiding the selection of moderators, the COSTRIDE intervention study and sample, and the relationships among baseline variables are provided. Participants were non-active individuals randomly assigned to either the STRIDE exercise or health-and-wellness contact control condition. Structural equation modeling was utilized to demonstrate that relationships among baseline variables confirm hypothesized relationships in the transdisciplinary framework. Preliminary data from COSTRIDE suggest that interventions among sedentary individuals may be more effective if a broader range of factors influencing physical activity are considered. [ABSTRACT FROM AUTHOR]

The negative impacts of parental mental health problems on children and adolescents are well known, but the relationship between a child's depression and their parents' health is not so well understood. Being a carer/parent of someone with mental illness can be associated with negative outcomes for the caregiver. This paper reports the associations between the mental health of adolescents with major depression and their parents, before and after treatment of the adolescent's depression. Data were collected as part of the Adolescent Depression Antidepressants and Psychotherapy Trial, a randomised controlled trial of selective serotonin reuptake inhibitors with and without cognitive behaviour therapy in 208 clinic-recruited adolescents with major depression. The baseline severity of depression in the adolescent was significantly associated with both maternal and paternal mental health (as rated by the General Health Questionnaire). This effect was not confounded by other psychiatric symptoms. The degree of improvement in parental and child mental health was positively correlated across time. Our results support the hypothesis that there is a significant association between parental mental health and adolescent depressive symptoms. This study was not able to establish the direction of this association. In clinical practice, the findings demonstrate the importance of considering the mental health of the parents when treating depressed adolescents. [ABSTRACT FROM AUTHOR]

The purpose of this investigation was to explore the effects of dietary weight loss intervention, with and without the addition of exercise on health-related quality of life, depressive symptoms, and anxiety. As part of the EMPOWER study for women, sixty premenopausal women (BMI of 40.4 ± 6.7) were randomized to energy restriction only (ER) or to exercise plus energy restriction (EXER) for 12 months. Health-related quality of life was assessed using the SF-36, depressive symptoms were assessed using the Beck Depression Inventory II (BDI), and anxiety symptoms using the Spielberger state and trait anxiety questionnaire. All measures were completed at baseline, 3, 6 and 12 months. At 12 months, there were significant (p < 0.05) group-by-time interactions favouring the EXER group for five of the eight domains and the mental component summary score. At 12 months, a significant group-by-time interaction favouring the EXER group is reported for both state and trait anxiety (p =.005 and p =.001, respectively). At 12 months, there was a significant group-by-time interaction for depressive symptoms favouring EXER (p < 0.05). Within-group changes for BDI scores were improved at all follow-up time points in the EXER group. Exercise training confers an additional benefit to energy restriction in the absence of additional weight loss at 12 months for health-related quality of life, depressive symptoms, and state and trait anxiety scores when compared to energy restriction only. Exercise and an energy-restricted diet improve health-related quality of life and mental health. Exercise may protect mental health without further weight loss for women with severe obesity. [ABSTRACT FROM AUTHOR]

Purpose: Diabetes remission is a phenomenon described in the context of drastic weight loss due to bariatric surgery or low-calorie diets. Evidence suggests that increasing the intake of plant protein could reduce the risk of type 2 diabetes. We sought for association between changes in plant protein intake in the context of 2 healthy diets without weight loss nor glucose-lowering medication, and diabetes remission in coronary heart disease patients from the CORDIOPREV study. Methods: Newly diagnosed type 2 diabetes participants without glucose-lowering treatment were randomized to consume a Mediterranean or a low-fat diet. Type 2 diabetes remission was assessed with a median follow-up of 60 months according to the ADA recommendation. Information on patient's dietary intake was collected using food-frequency questionnaires. At first year of intervention, 177 patients were classified according to changes in plant protein consumption into those who increased or decreased its intake, in order to perform an observational analysis on the association between protein intake and diabetes remission. Results: Cox regression showed that patients increasing plant protein intake were more likely to remit from diabetes than those who decreased its intake (HR = 1.71(1.05–2.77)). The remission occurred mainly at first and second year of follow-up with diminished number of patients achieving remission in the third year onwards. The increase in plant protein was associated with lower intake of animal protein, cholesterol, saturated fatty acids, and fat, and with higher intake of whole grains, fibre, carbohydrates, legumes, and tree nuts. Conclusion: These results support the need to increase protein intake of vegetal origin as dietary therapy to reverse type 2 diabetes in the context of healthy diets without weight loss. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose Neck pain is common among office workers and leads to work productivity loss. This study aimed to investigate the effect of a multi-component intervention on neck pain-related work productivity loss among Swiss office workers. Methods Office workers, aged 18–65 years, and without serious neck-related health problems were recruited from two organisations for our stepped-wedge cluster randomized controlled trial. The 12-week multi-component intervention included neck exercises, health-promotion information, and workplace ergonomics. The primary outcome of neck pain-related work productivity loss was measured using the Work Productivity and Activity Impairment Questionnaire and expressed as percentages of working time. In addition, we reported the weekly monetary value of neck pain-related work productivity loss. Data was analysed on an intention-to-treat basis using a generalized linear mixed-effects model. Results Data from 120 participants were analysed with 517 observations. At baseline, the mean age was 43.7 years (SD 9.8 years), 71.7% of participants were female (N = 86), about 80% (N = 95) reported mild to moderate neck pain, and neck pain-related work productivity loss was 12% of working time (absenteeism: 1.2%, presenteeism: 10.8%). We found an effect of our multi-component intervention on neck pain-related work productivity loss, with a marginal predicted mean reduction of 2.8 percentage points (b = −0.27; 95% CI: −0.54 to −0.001, p = 0.049). Weekly saved costs were Swiss Francs 27.40 per participant. Conclusions: Our study provides evidence for the effectiveness of a multi-component intervention to reduce neck pain-related work productivity loss with implications for employers, employees, and policy makers. Trial Registration ClinicalTrials.gov, NCT04169646. Registered 15 November 2019—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04169646. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of an anti-inflammatory compared to a low-calorie diet on the physical and mental health of patients with knee OA. Methods: In this randomized parallel clinical trial, participants were selected among overweight and obese women aged 40 years or older with mild to moderate OA. Sixty women with a ratio of 1:1 were randomly assigned to receive either low-calorie or anti-inflammatory accompanied by a low-calorie diet for two months. The dietary intake and weight of participants were measured. Study variables were assessed using the Western Ontario and McMaster Index (WOMAC), visual analog pain scale (VAS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI-I), and the Short Form 36 Health Survey Questionnaire (SF-36) to indicate the quality of life (QoL). Results: There was no statistically significant difference between the two groups in demographic and baseline variables except for the emotional well-being subscale of QoL. There was significant difference in anti-inflammatory compared to low-calorie diet in terms of weight (MD (95% CI): − 4.02 kg (− 6.77 to − 1.28); p = 0.005), VAS (MD (95% CI): − 0.97 (− 1.53 to − 0.41); p = 0.001), WOMAC-total score (MD (95% CI): − 9.91 (− 15.05 to − 4.78); p < 0.001), WOMAC-pain subscale (MD (95% CI): − 3.30 (− 5.30 to − 1.29); p = 0.002), WOMAC-physical function (MD(95% CI): − 5.48 (− 9.41 to − 1.53); p = 0.007), depression (p = 0.003), anxiety (p = 0.011), QoL-physical functioning (0.041), and QoL-pain (0.010) after the intervention. Conclusion: An anti-inflammatory accompanied by a low-calorie diet resulted in greater weight loss and greater improvement in pain intensity, functional status, depression, anxiety, and some dimension of QoL in overweight and obese women with knee OA compared to the low-calorie diet. Trial registration number and date of registration: IRCT201610220030424N2; 2018-04-23. [ABSTRACT FROM AUTHOR]

Gamification, the application of gaming elements to increase enjoyment and engagement, has the potential to improve the effectiveness of digital health interventions, while the effectiveness of competition gamification components remains poorly understood on residency. To address this gap, we evaluate the effect of smartphone-based gamified team competition intervention on daily step count and sleep duration via a micro-randomized trial on medical interns. Our aim is to assess potential improvements in the factors (namely step count and sleep) that may help interns cope with stress and improve well-being. In 1779 interns, team competition intervention significantly increases the mean daily step count by 105.8 steps (SE 35.8, p = 0.03) relative to the no competition arm, while does not significantly affect the mean daily sleep minutes (p = 0.76). Moderator analyses indicate that the causal effects of competition on daily step count and sleep minutes decreased by 14.5 steps (SE 10.2, p = 0.16) and 1.9 minutes (SE 0.6, p = 0.003) for each additional week-in-study, respectively. Intra-institutional competition negatively moderates the causal effect of competition upon daily step count by −90.3 steps (SE 86.5, p = 0.30). Our results show that gamified team competition delivered via mobile app significantly increases daily physical activity which suggests that team competition can function as a mobile health intervention tool to increase short-term physical activity levels for medical interns. Future improvements in strategies of forming competition opponents and introducing occasional competition breaks may improve the overall effectiveness. [ABSTRACT FROM AUTHOR]

The need for effective intervention programs for youth with neurodevelopmental problems (ESSENCE) and challenging behaviour is great. This study examines Problem Resolution in ESSENCE (PR-ESSENCE), a newly developed model in which children and parents develop mutual problem resolution strategies. Ten-week randomized controlled trial of PR-ESSENCE for children and adolescents aged 5–18 years, compared to treatment as usual. Outcomes were assessed at baseline and randomized period endpoint. Primary outcome was the Clinical Global Impression—Improvement scale (CGI-I) rated by blinded assessors. Secondary outcomes were rated by parents—SNAP-IV, Eyberg Child Behavior Inventory (ECBI), Relationship Problems Questionnaire, Family Burden of Illness Module, and children—Beck Youth Inventories (BYI). ClinicalTrials.gov identifier: NCT03780413. The study enrolled 108 participants (active n = 72; controls n = 36, randomized 2:1), of whom 95 completed the randomized period. No clinically significant group differences were found in baseline characteristics. More than half had autism and 80% had ADD or ADHD. Large treatment effects were seen on CGI-I (ITT analysis, Effect Size 1.48). Treatment responders, much/very much improved on CGI-I, were 51.4% in active group and 5.6% of controls. Effect sizes were medium to large in parent ratings on SNAP-IV (ODD and ADHD symptoms), ECBI (behaviour problems), and in BYI child self-ratings of disruptive behaviour. PR-ESSENCE treatment improved global symptoms and functioning (CGI-I), behaviour problems, ADHD and ODD symptoms, and disruptive behaviour. Treatment effects were at least equivalent to those in previous studies of well-established Parent Management Training and Collaborative Problem Solving programs. [ABSTRACT FROM AUTHOR]

Background: Use of numerical and spatial language, also known as math talk, is critical to the development of foundational number and spatial skills in early childhood. However, caregivers and children of low socioeconomic status (SES) tend to use less math talk than their higher-SES peers. Objective: The current efficacy study tested the hypothesis that quantity of math talk among low-SES caregivers and children is increased via a caregiver education curriculum aimed at improving caregivers' language input to children. Methods: Caregiver-child dyads (n = 37; children aged 17 to 36 months) participated in either the language input or a control intervention. Math talk (operationalized as number and spatial word tokens) was coded from video recordings of each dyad engaging in free play at three time points: baseline, post-intervention, and follow-up. Results: The language input curriculum significantly increased caregivers' amount of spatial talk and cildren's amount of number and spatial talk for up to 4 months after the intervention. Conclusions: A caregiver education intervention increased caregivers' use of math talk, which resulted in higher math talk usage by their children. Further verification is needed through an adequately powered longitudinal randomized controlled trial. [ABSTRACT FROM AUTHOR]

Purpose In order to support people with low back pain (LBP) to stay at work, work arrangements are regarded important. This study aimed to evaluate the effectiveness of a workplace intervention using a participatory approach on work disability of workers with ongoing or recurrent LBP. Methods A total of 107 workers with LBP, with duration of pain for at least two consecutive weeks or recurrent pain of any duration during the last year, were randomized either to the intervention (n = 51) or control group (n = 56). The intervention included arrangements at the workplace, along with individual guidance provided by an occupational physiotherapist (OPT). The randomized intervention study used standard counselling and guidance by an OPT without workplace intervention as a comparison. Surveys were completed at baseline, and 6 and 12 months after baseline. Results There were no statistically significant differences between the intervention and control groups on the primary outcome measure, i.e. self-assessed work ability. We found no between-group differences in perceived health, self-assessed work productivity, number of sickness absence days and severity of back pain. However, there were significant positive within-group changes in the intervention group in the intensity of LBP, perceived health and the number of sickness absence days due to LBP. Conclusion Workplace arrangements are feasible using participatory ergonomics, but more quantitative and qualitative research is needed on its utilization and effectiveness among workers with LBP. [ABSTRACT FROM AUTHOR]

The article presents a study which analyses efficacy of facial emotion training program for children and adolescents with autism spectrum disorder (ASD). Topics discussed include co-morbid anxiety and mood disorders in individuals with ASD, computer-based programs to teach facial emotion recognition skills to ASD patients, and coach-assisted MiX training.

Purpose An increasing number of workers in the US have chronic health conditions that limit their ability to work, and few worksite interventions have been tested to improve worker coping and problem solving at work. The purpose of this study was to evaluate a worksite-based health self-management program designed to improve workplace function among workers with chronic health conditions. Methods We conducted a randomized, controlled trial of a worksite self-management program ("Manage at Work") (clinicaltrials.gov #NCT01978392) for workers with chronic health conditions (N = 119; 82% female, ages 20–69). Most workers were recruited from the health care or light manufacturing industry sectors. Workers attended a 5-session, facilitated psychoeducational program using concepts of health self-management, self-efficacy, ergonomics, and communication. Changes on outcomes of work engagement, work limitation, job satisfaction, work fatigue, work self-efficacy, days absent, and turnover intention at 6-month follow-up were compared to wait-list controls. Results The most prevalent chronic health conditions were musculoskeletal pain, headaches, vision problems, gastrointestinal disorders, respiratory disorders, and mental health disorders. The self-management program showed greater improvement in work engagement and turnover intent at 6-month follow-up, but there was no evidence of a parallel reduction in perceived work limitation. Trends for improved outcomes of work self-efficacy, job satisfaction, and work fatigue in the intervention group did not reach statistical significance in a group x time interaction test. Conclusions Offering a worksite self-management program to workers with chronic health conditions may be a feasible and beneficial strategy to engage and retain skilled workers who are risking disability. Clinical trial registration: Clinicaltrials.gov #NCT01978392. [ABSTRACT FROM AUTHOR]

Introduction: In a randomized controlled trial, we previously investigated if melanoma patients receiving checkpoint inhibitors had fewer severe immune-related adverse events (irAEs) when they reported symptoms using electronic patient-reported outcomes (ePRO) with triggered alerts as an add-on to standard care, compared to standard care alone. The aim of this study is to examine between-group differences in health-related quality of life (HRQoL) and associations between irAEs severity and HRQoL. Methods: The study population of 138 patients completed the EuroQol EQ-5D-5L Index and FACT-M questionnaires at baseline and weeks 24 and 48. We analyzed HRQoL from all patients who completed at least one questionnaire. Missing FACT-M items were imputed following existing guidelines. Results: There was no difference in HRQoL at baseline as measured EQ-5D-5L between the intervention and the control group. Between baseline and 48 weeks, mean EQ-5D-5L scores were unchanged among patients in the intervention group (p = 0.81) but decreased significantly among patients in the control group (p = 0.03). Consequently, patients in the intervention group had higher mean scores than those in the control group (p = 0.05) at 48 weeks. Mean FACT-M scores did not differ significantly between the two groups at any of the time points. There were observed no between-group differences in mean EQ-5D-5 and mean FACT-M scores between patients with severe irAEs and patients who had none. Conclusion: Melanoma patients receiving CPIs who self-reported irAEs using ePRO with triggered alerts as a supplement to standard care maintained their HRQoL compared to patients who received standard care alone. Patients in the intervention group had a significantly better HRQoL measured by EQ-5D-5L than controls 48 weeks after baseline. The results suggest that including ePRO in standard care increases melanoma patients´ well-being. Further and larger studies are needed to confirm this finding and examine the impact of severe irAEs on cancer patients' HRQoL. Trial registration: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registeredhttps://clinicaltrials.gov/. [ABSTRACT FROM AUTHOR]

African American and Hispanic women report less physical activity (PA) than non-Hispanic White women. As such, a digitally-enhanced 16-week social support pilot intervention was conducted to promote PA among African American and Hispanic women dyads. This study quantitatively and qualitatively examined the engagement and satisfaction of participants (N = 30; 15 dyads) assigned to the intervention. Intervention participants received telephone counseling calls based on motivational interviewing and a Jawbone UP activity monitor. Intervention engagement and satisfaction data were collected from the Jawbone UP, call logs, self-report questionnaires conducted at the 16-week follow-up, and two post-intervention focus groups. Nonparametric tests assessed group differences across engagement and satisfaction measures, and a manually-driven coding scheme was used to evaluate emerging themes from qualitative text. Participants demonstrated high engagement in the telephone counseling sessions and moderate engagement with the Jawbone UP. Friend/co-worker dyads and participants who were 45 years and older were more likely to use the device. Qualitative results emphasized participants' appreciation for the counseling calls, the Jawbone UP, and the overall dyadic framework of the study to collectively nurture social support and accountability for PA. Overall, the intervention group reacted positively to study components. Additional research is needed to understand the role of technology in facilitating long-lasting PA change via social support in minority populations. [ABSTRACT FROM AUTHOR]

BackGround: Studies on feedback in youth mental health care are scarce and implementation of feedback into clinical practice is problematic. Objective: To investigate potentially effective components of feedback from Routine Outcome Monitoring (ROM) in youth mental health care in the Netherlands through a three-arm, parallel-group, randomized controlled trial in which a literature-based, multi-faceted implementation strategy was used. Method: Participants were randomly allocated to three conditions (basic feedback about symptoms and quality of life; basic feedback supplemented with clinical support tools; discussion of the feedback of the second condition with a colleague while following a standardized format for case consultation) using a block randomization procedure, stratified by location and participants' age. The youth sample consisted of 225 participants (mean age = 15.08 years; 61.8% female) and the parent sample of 234 mothers and 54 fathers (mean age of children = 12.50 years; 47.2% female). Primary outcome was symptom severity. Secondary outcomes were quality of life and end-of-treatment variables. Additionally, we evaluated whether being Not On Track (NOT) moderated the association between condition and changes in symptom severity. Results: No significant differences between conditions and no moderating effect of being NOT were found. This outcome can probably be attributed to limited power and implementation difficulties, such as infrequent ROM, unknown levels of viewing and sharing of feedback, and clinicians' poor adherence to feedback conditions. Conclusions: The study contributes to our limited knowledge about feedback from ROM and underscores the complexity of research on and implementation of ROM within youth mental health care. Trial registration Dutch Trial Register NTR4234. [ABSTRACT FROM AUTHOR]

Erectile dysfunction and stress are among common post-CABG surgery complications. The present study was conducted to assess the effect of modified cardiac rehabilitation on "erectile dysfunction" and "coping with stress". In the present clinical trial study, 126 male patients undergoing CABG surgery were randomly assigned to treatment (63 patients) and control (63 patients) groups. Control group received conventional cardiac rehabilitation program over 26 sessions. Treatment group received modified cardiac rehabilitation program, including Kegel exercise and training on stress coping strategies in the first four sessions of their rehabilitation program. Patients were assessed before and after cardiac rehabilitation program using the International Index of Erectile Dysfunction (IIEF-5) questionnaire and Endler and Parker Coping with Stress Scale. Data were analyzed in SPSS using ANOVA, T, and Chi square tests. Mean erectile function score significantly increased in both treatment and control groups, but the difference in mean scores for improvement in erectile function was greater in treatment group (P < 0.001). Analysis showed no significant difference in mean differences between two groups in all subscales of stress coping. Intragroup analysis showed significant differences in both groups between mean differences before and after intervention in task-oriented styles {treatment group (P < 0.002), control group (P < 0.001)}, and social diversion-oriented. The results showed that conventional and modified cardiac rehabilitation can be effective in improving erectile dysfunction and stress coping in task-oriented and social diversion-oriented styles in the men patients with left ventricular ejection fraction over 30% following CABG surgery. However, modified cardiac rehabilitation has greater benefits for improving erectile dysfunction. [ABSTRACT FROM AUTHOR]

Background: Physical activity (PA) interventions in people with spinal cord injury (SCI) have been limited by a shortage of (1) evidence for sufficient increases in unsupervised PA to improve aerobic fitness and (2) stakeholder involvement in intervention design. Objectives: This study examined the effects of a theory-based PA intervention, developed in collaboration with nearly 300 stakeholders, on PA levels, aerobic fitness, and psychosocial predictors of PA among individuals with SCI. Methods: A randomized controlled trial (RCT) was conducted with 28 men and women with chronic SCI (age 45.0 ± 11.5 years, years post-injury 16.4 ± 12.4). Participants randomized to the intervention group (n = 14) received an introductory personal training session followed by eight weekly 15-min PA behavioral coaching sessions per week. PA was assessed using self-report and accelerometers. Aerobic fitness and psychosocial predictors of exercise were evaluated using an incremental exercise test and survey methods, respectively. Results: At post-intervention, controlling for baseline, the intervention group showed fivefold greater self-reported moderate to vigorous physical activity [mean difference 247.9 min/day; 95% confidence interval (CI) 92.8–403.1; p = 0.026, d = 1.04], 17% greater accelerometer-measured PA (mean difference 3.9 × 105 vector magnitude counts; 95% CI 1.1 × 104–7.7 × 105; p = 0.014, d = 0.31), and 19% higher peak oxygen uptake (VO2Peak; mean difference 0.23 L/min; 95% CI 0.12–0.33; p < 0.001, d = 0.54) compared with the control group. Mean values of psychosocial predictors of PA were also significantly improved in the intervention group compared with controls. Conclusion: To our knowledge, this co-created behavioral intervention produced the largest effect size to date for change in self-reported PA in an RCT involving people with physical disability. This is also the first RCT in people with SCI to demonstrate that a behavioral intervention can sufficiently increase unsupervised PA to improve aerobic fitness. Trial Registration: ClinicalTrials.gov, NCT03111030, 12 April 2017, https://clinicaltrials.gov/ct2/show/NCT03111030?term=NCT03111030&rank=1. [ABSTRACT FROM AUTHOR]

This study evaluated whether a self-administered stress management training (SSMT) could improve quality of life (QOL) and reduce distress among Hispanics receiving chemotherapy across multiple community clinical settings. Participants were randomized to receive SSMT (n = 106) or usual care (UCO) (n = 113). The primary outcome-QOL (SF-36) and secondary outcomes depression (CES-D), and anxiety (STAI) were assessed longitudinally over four chemotherapy cycles. Acculturation (BAS) and patients' intervention adherence were assessed. About 63% of participants reported distress after the initial chemotherapy cycle. Hispanics with lower acculturation reported greater STAI-Trait scores (p = .003). No significant treatment effects on outcomes measures were observed for participants receiving SSMT. SSMT intervention techniques were reported useful and improved mental health scores were observed with patients on a psychotropic agent (p = .04). Hispanics experience an elevated level of distress, yet SSMT did not significantly improve primary outcomes. SSMT may be potentially effective when combined with a psychotropic agent. SSMT enhancing strategies are discussed. [ABSTRACT FROM AUTHOR]

Purpose This study aimed to perform a process evaluation of a participatory supportive return to work program for workers without a (permanent) employment contract, sick-listed due to a common mental disorder. The program consisted of a participatory approach, integrated care and direct placement in a competitive job. Our main questions were: were these components realized in practice and in accordance with the protocol? The evaluation took place alongside a randomized controlled trial. Methods The study population consisted of workers who filed a sickness benefit claim at the Dutch Social Security Agency, professionals of this agency and of vocational rehabilitation agencies. We focused on sick-listed workers and professionals who had actually participated in the intervention. Data was collected mainly by questionnaires. Results Only 36 out of 94 intervention group participants started with the program. In half of these cases application of integrated care was reported. Most other steps in the program were completed. However, fidelity to the protocol was low to reasonable. Much delay was observed in the execution of the program and only two sick-listed workers were placed in a competitive job. Still, satisfaction with the participatory approach was good. Conclusions Despite the positive evaluation of the participatory approach, the full program was executed less successfully compared to similar programs evaluated in earlier studies. This will probably affect the outcomes of our trial. Findings from this study will help to interpret these outcomes. Nevertheless, more knowledge is needed about experiences of stakeholders who participated in the program. Trial Registration NTR3563. [ABSTRACT FROM AUTHOR]

The Social Anxiety - Acceptance and Action Questionnaire (SA-AAQ; MacKenzie and Kocovski 2010) is a 19-item self-report measure designed to assess acceptance and action specific to social anxiety symptoms. The present research was designed to evaluate an abbreviated version of the SA-AAQ. This abbreviated scale was confirmed using an undergraduate sample ( N = 148) in Study 1 and a clinical sample of individuals with social anxiety disorder in Study 2 ( N = 137). Results indicated that an eight-item, two-factor model (acceptance and action) provided a good fit for the Brief SA-AAQ in both samples. Finally, we also found preliminary evidence in support of the convergent, discriminant/divergent, and incremental validity of the shortened scale. The Brief SA-AAQ shows promise as a useful and brief tool for the measurement of acceptance of social anxiety symptoms in socially anxious populations. [ABSTRACT FROM AUTHOR]

SMS is a widely used technology globally and may also improve ART adherence, yet SMS notifications to social supporters following real-time detection of missed doses showed no clear benefit in a recent pilot trial. We examine the demographic and social-cultural dynamics that may explain this finding. In the trial, 63 HIV-positive individuals initiating ART received a real-time adherence monitor and were randomized to two types of SMS reminder interventions versus a control (no SMS). SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses. Like participants, social supporters were interviewed at enrollment, following their matched participant's adherence lapse and at exit. Social supporters with regular income (RR = 0.27, P = 0.001) were significantly associated with fewer adherence lapses. Instrumental support was associated with fewer adherence lapses only among social supporters who were food secure (RR = 0.58, P = 0.003). Qualitative interview data revealed diverse and complex economic and relationship dynamics, affecting social support. Resource availability in emotionally positive relationships seemingly facilitated helpful support, while limited resources prevented active provision of support for many. Effective social support appeared subject to social supporters' food security, economic stability and a well-functioning social network dependent on trust and supportive disclosure. [ABSTRACT FROM AUTHOR]

Male partner involvement has the potential to increase uptake of interventions to prevent mother-to-child transmission of HIV (PMTCT). Finding cultural appropriate strategies to promote male partner involvement in PMTCT programs remains an abiding public health challenge. We assessed whether a congregation-based intervention, the Healthy Beginning Initiative (HBI), would lead to increased uptake of HIV testing among male partners of pregnant women during pregnancy. A cluster-randomized controlled trial of forty churches in Southeastern Nigeria randomly assigned to either the HBI (intervention group; IG) or standard of care referral to a health facility (control group; CG) was conducted. Participants in the IG received education and were offered onsite HIV testing. Overall, 2498 male partners enrolled and participated, a participation rate of 88.9%. Results showed that male partners in the IG were 12 times more likely to have had an HIV test compared to male partners of pregnant women in the CG (CG = 37.71% vs. IG = 84.00%; adjusted odds ratio = 11.9; p < .01). Culturally appropriate and community-based interventions can be effective in increasing HIV testing and counseling among male partners of pregnant women. [ABSTRACT FROM AUTHOR]

Finding fit between work and family responsibilities is challenging for parents, especially when raising a child with mental health difficulties. The purpose of this study was to investigate the relationship of children's problematic behaviors to maternal employment and difficulty combining work and family obligations. Data were analyzed from 174 mothers parenting a child with a diagnosis of attention deficit hyperactivity disorder who completed child problem behavior (child behavior checklist), family functioning, and employment measures at baseline and 12 months later. Results from logistic regression analysis indicated that children's problematic behaviors predicted maternal employment. Structural equation modeling showed that children's higher baseline scores on the child behavior checklist internalizing scale were related to difficulty combining work and family at 12 months, even after controlling for difficulty of combining work and family at baseline. Children's externalizing scores were not found to predict difficulty combining work and family responsibilities. Further analysis did not confirm mediation between children's externalizing and internalizing behaviors, family conflict, and difficulty combining work and family. Given these results, service providers need to more comprehensively address the intersection of children's mental health difficulties and work-family fit in order to better support caregivers as parents and employees. [ABSTRACT FROM AUTHOR]

The article discusses a study on an Assisted Self-Management Monitor (ASMM) that is made to overcome barriers through the application of the common sense model and principles of behavior modification. Topics covered include the types of feedback provided by the ASMM, adaptations of existing scales to measure self efficacy for diabetes self-care and fear of hyperglycemia, and analysis of variables associated with glycemic control in prior studies.

Purpose: Increased awareness of the importance of dietary fibre has led to increased interest in 'functional' fibre components like digestion-resistant maltodextrin (RMD). This randomized, placebo-controlled, double-blind study assessed the effects of RMD in the colonic transit time (CTT) and defecation characteristics (frequency, stool volume and consistency). Methods: Sixty-six healthy adult volunteers (32 men) who did not have a daily defecation habit had a 7-day run-in period before the 21-day intervention period with RMD or placebo. CTT and segmental CTT (SCTT) were assessed by a single abdominal X-ray film taken at the end of both periods after radiopaque marker ingestion. Defecation characteristics and intestinal functions were also assessed, which were self-reported by patients. Intragroup comparisons were evaluated by Student's paired t test, Bonferroni test and Chi-square test, while time comparisons by analysis of variance (ANOVA) and time-by-treatment interaction by repeated-measures ANOVA. Results: Fifty-seven subjects were assessed for CTT (placebo, n = 28; RMD, n = 29). In the RMD group, the total CTT, left SCTT and rectosigmoidal SCTT decreased significantly compared to baseline ( p < 0.01 each; −13.3, −4.7, −8.7 h, respectively). Significant differences between groups were observed in total CTT and left SCTT. Significant time-by-treatment interaction was observed in the RMD group for stool volume ( p = 0.014), increasing 56 % compared to baseline ( p < 0.01), while remained unchanged in the placebo group. Stool consistency was improved only in the RMD group ( p < 0.01). No adverse effects related to study products were observed. Conclusions: The results show that RMD improved CTT, stool volume, stool consistency and some intestinal functions in a healthy population. [ABSTRACT FROM AUTHOR]

Childhood internalizing problems such as anxiety and depression can have serious personal, familial and societal repercussions, including drug and alcohol abuse, delinquency, unplanned pregnancy, and even suicide. There is little research on mindfulness interventions for children with clinical levels of internalizing problems, and school-based mindfulness research with children has focused on non-clinical groups. We employed a two-stage screening and intervention procedure to evaluate an in-school mindfulness-based cognitive intervention for Hong Kong children with subclinical internalizing difficulties. Ninety-three fourth to sixth graders were screened, and twenty students (age 9-13, median age 10) highest among their peers on internalizing problems, but lowest on externalizing problems, participated in a 9-week group mindfulness-based intervention. We employed a two-phase open trial design, with random assignment to an immediate intervention group or wait-list control group. In single-trial analysis, one-tailed dependent sample t-tests showed significant decreases in both worry and in symptoms of panic disorder, obsessive compulsive disorder, generalized anxiety and overall internalizing problems. In a randomized controlled trial analysis, the immediate intervention group evidenced larger but nonsignificant reductions on almost all measures. Eighty-five percent of the participants rated the program as helpful, and 65-80 % reported improvement in handling emotions and interpersonal relationships at post-treatment, with some treatment gains maintained at 3-month follow-up. These preliminary findings have encouraging implications for implementing time-limited school-based mindfulness interventions targeting elevated childhood internalizing difficulties. [ABSTRACT FROM AUTHOR]

Background: Medication overuse headache (MOH) is a major clinical concern and a common health risk. Recent literature stressed the need to manage chronic headache by using integrated biobehavioral approaches. Few studies evaluated how biofeedback can be useful in MOH. The aim of the study is to evaluate in a randomized, controlled, single-blind trial the effects of biofeedback associated with traditional pharmacological therapy in the prophylactic treatment of MOH. Method: Twenty-seven subjects were randomized to frontal electromyographic (EMG) biofeedback associated with prophylactic pharmacological therapy (Bfb Group) or to pharmacological treatment alone (Control Group). The primary outcome was to evaluate the number of patients that return episodic after treatment. Secondly we evaluate the effects of frontal EMG BFB on frequency of headache and analgesic intake. Changes in coping strategies and in EMG frontalis tension were also evaluated. ANOVA was performed on all the variables of interest. Results: Our results indicate that at the end of treatment the number of patients that returned episodic in the Bfb group was significantly higher than in the Control group. Patients in the Bfb group differed from the Control group in headache frequency, amount of drug intake and active coping with pain. These outcomes were confirmed also after 4 months of follow-up. No significant effects were observed in EMG recordings. Conclusions: Biofeedback added to traditional pharmacological therapy in the treatment of MOH is a promising approach for reducing headache frequency and analgesic intake. Modification of coping cognitions in the Bfb group, as an adjunct mechanism of self-regulation, needs more evaluations to understand the role of biofeedback in changing maladaptive psychophysiological responses. [ABSTRACT FROM AUTHOR]

Purpose: Epidemiological evidence suggests that chronic consumption of fruit-based flavonoids is associated with cognitive benefits; however, the acute effects of flavonoid-rich (FR) drinks on cognitive function in the immediate postprandial period require examination. The objective was to investigate whether consumption of FR orange juice is associated with acute cognitive benefits over 6 h in healthy middle-aged adults. Methods: Males aged 30-65 consumed a 240-ml FR orange juice (272 mg) and a calorie-matched placebo in a randomized, double-blind, counterbalanced order on 2 days separated by a 2-week washout. Cognitive function and subjective mood were assessed at baseline (prior to drink consumption) and 2 and 6 h post consumption. The cognitive battery included eight individual cognitive tests. A standardized breakfast was consumed prior to the baseline measures, and a standardized lunch was consumed 3 h post-drink consumption. Results: Change from baseline analysis revealed that performance on tests of executive function and psychomotor speed was significantly better following the FR drink compared to the placebo. The effects of objective cognitive function were supported by significant benefits for subjective alertness following the FR drink relative to the placebo. Conclusions: These data demonstrate that consumption of FR orange juice can acutely enhance objective and subjective cognition over the course of 6 h in healthy middle-aged adults. [ABSTRACT FROM AUTHOR]

Purpose: Consumption of sugar-reformulated products (commercially available foods and beverages that have been reduced in sugar content through reformulation) is a potential strategy for lowering sugar intake at a population level. The impact of sugar-reformulated products on body weight, energy balance (EB) dynamics and cardiovascular disease risk indicators has yet to be established. The REFORMulated foods (REFORM) study examined the impact of an 8-week sugar-reformulated product exchange on body weight, EB dynamics, blood pressure, arterial stiffness, glycemia and lipemia. Methods: A randomized, controlled, double-blind, crossover dietary intervention study was performed with fifty healthy normal to overweight men and women (age 32.0 ± 9.8 year, BMI 23.5 ± 3.0 kg/m) who were randomly assigned to consume either regular sugar or sugar-reduced foods and beverages for 8 weeks, separated by 4-week washout period. Body weight, energy intake (EI), energy expenditure and vascular markers were assessed at baseline and after both interventions. Results: We found that carbohydrate ( P < 0.001), total sugars ( P < 0.001) and non-milk extrinsic sugars ( P < 0.001) (% EI) were lower, whereas fat ( P = 0.001) and protein ( P = 0.038) intakes (% EI) were higher on the sugar-reduced than the regular diet. No effects on body weight, blood pressure, arterial stiffness, fasting glycemia or lipemia were observed. Conclusions: Consumption of sugar-reduced products, as part of a blinded dietary exchange for an 8-week period, resulted in a significant reduction in sugar intake. Body weight did not change significantly, which we propose was due to energy compensation. [ABSTRACT FROM AUTHOR]

ADHD affects working memory (WM) and other executive functions (EFs) and thereby negatively impacts school performance, clinical symptoms and functional impairment. The main aim of this study was to analyse the efficacy of computerized WM training (CWMT) on EF rating scales. A secondary objective was to assess its efficacy on performance-based measures of EF (PBMEF), learning, clinical symptoms and functional impairment. 66 children with combined-type ADHD between 7 and 12 years of age from the Child and Adolescent Psychiatric Unit (Spain) were included in this randomized, double-blind, placebo-controlled, parallel-group clinical trial. The participants were randomized (1:1) to an experimental group (EG) (CWMT) ( n = 36) or a control group (CG) (placebo training). Assessments were conducted at baseline (T0), 1-2 weeks (T1), and 6 months post-intervention (T2) with the administration of EF rating scales, PBMEF, measures of academic achievement, and questionnaires regarding clinical symptoms and functional impairment. Participants, parents, teachers and professionals who performed the cognitive assessments were blinded. Adjusted multiple linear regression analysis showed significant improvements in EF scales-parent version, from T1 to T2, on the metacognition index [ p = 0.03, d′ = −0.78 (95 % CI −1.28 to −0.27)] and on WM (also significant at T2-T0) and plan/organize subscales. Significant improvements were also noted in EF scales-teacher version, from T0 to T1 and T2, on the metacognitive index [ p = 0.05, d′ = −0.37 (95 % CI −0.86 to 0.12) T1-T0, p = 0.02, d' = −0.81 (95 % CI −1.31 to −0.30) T2-T0] and on the initiate, WM, monitor and shift subscales. There were also significant improvements in PBMEF, ADHD symptoms, and functional impairment. CWMT had a significant impact on ADHD deficits by achieving long-term far-transfer effects. [ABSTRACT FROM AUTHOR]

The article focuses on a study of health-related and sleep factors in obese rural women through randomized controlled trial. Topics discussed include negative impact of rural health disparities and environmental factors on sleep duration and obesity, association of short sleep duration with cardiometabolic disease risk and inflammation and high pain interference scores associated with higher sleep disturbance scores.

Purpose: The aim of this study was to determine whether combining potential biomarkers of fruit and vegetables is better at predicting FV intake within FV intervention studies than single biomarkers. Design: Data from a tightly controlled randomised FV intervention study (BIOFAV; all food provided and two meals/day on weekdays consumed under supervision) were used. A total of 30 participants were randomised to either 2, 5 or 8 portions FV/day for 4 weeks, and blood samples were collected at baseline and 4 weeks for plasma vitamin C and serum carotenoid analysis. The combined biomarker approach was also tested in three further FV intervention studies conducted by the same research team, with less strict dietary control (FV provided and no supervised meals). Results: The combined model containing all carotenoids and vitamin C was a better fit than either the vitamin C only ( P < 0.001) model or the lutein only ( P = 0.006) model in the BIOFAV study. The C-statistic was slightly lower in the lutein only model (0.85) and in the model based upon factor analysis (0.88), and much lower in the vitamin C model (0.68) compared with the full model (0.95). Results for the other studies were similar, although the differences between the models were less marked. Conclusions: Although there was some variation between studies, which may relate to the level of dietary control or participant characteristics, a combined biomarker approach to assess overall FV consumption may more accurately predict FV intake within intervention studies than the use of a single biomarker. The generalisability of these findings to other populations and study designs remains to be tested. Clinical trial Registration Number NCT01591057 (). [ABSTRACT FROM AUTHOR]

Purpose: Specific combinations of dietary fiber (DF) have been observed to result in improved glucose tolerance at a subsequent standardized breakfast. Arabinoxylan oligosaccharides (AXOS) are considered as DF with prebiotic potential, but so far no studies have investigated their metabolic effects in humans. This randomized cross-over study evaluated the overnight impact of breads containing AXOS-rich wheat bran extract and resistant starch (RS, Hi-Maize), separately or combined, on glucose tolerance, related metabolic parameters and markers of gut fermentation in healthy subjects. Methods: Evening reference and test products were: (1) reference white wheat flour bread (WWB), WWB supplemented with (2) AXOS and RS (WWB + AXOS + RS), (3) an increased content of either AXOS (WWB + hiAXOS) or (4) RS (WWB + hiRS). At the subsequent standardized breakfast, blood was sampled for 3 h to monitor glucose, insulin, nonesterified fatty acids, glucagon-like peptide (GLP)-1 and GLP-2. Breath hydrogen (H) and short chain fatty acids (SCFA) were measured as markers of gut fermentation, and subjective appetite was rated using visual analog scales. Results: Dose-dependent decreases in glucose responses were observed with increased AXOS over the duration of 3 h. Insulin sensitivity index was improved in the morning after the WWB + hiAXOS evening meal. An increase in breath H concentration and circulating SCFA was observed in the morning after both evening meals containing AXOS. Conclusion: The present study indicates that AXOS have the potential of improving glucose tolerance in an overnight perspective and suggested mechanisms are improved insulin sensitivity and increased gut fermentation. [ABSTRACT FROM AUTHOR]