Wait-list Control Group Research Articles

Effectiveness of hybrid simulation training on medical student performance in whole-task consultation of cardiac patients: The ASSIMILATE EXCELLENCE randomized waitlist-controlled trial

BackgroundAssessment of comprehensive consultations in medicine, i.e. a complete history, physical examination, and differential diagnosis, is regarded as authentic tests of clinical competence; however, they have been shown to have low reliability and validity due to variability in the real patients used and subjective examiner grading. In the ASSIMILATE EXCELLENCE study, our aim was to assess the effect(s) of expert tuition with hybrid simulation using a simulated patient wearing a novel auscultation vest, i.e. a hybrid simulated patient, and repeated peer grading using scoring checklists on student learning, performance, and acumen in comprehensive consultations of patients with valvular heart disease.MethodsASSIMILATE EXCELLENCE was a randomized waitlist-controlled trial with blinded outcome assessment undertaken between February 2021 and November 2021. Students at the Royal College of Surgeons in Ireland in either the second or third year of the four-year graduate-entry medical degree programme were randomized to a hybrid simulation training or waitlist control group and undertook three consultation assessments of three different clinical presentations of valvular heart disease (cases: C1–C3) using hybrid simulation. Our primary outcome was the difference in total score between and within groups across time; a secondary outcome was any change in inter-rater reliability across time. Students self-reported their proficiency and confidence in comprehensive consultations using a pre- and post-study survey.ResultsIncluded were 68 students (age 27.6 ± 0.1 years; 74% women). Overall, total score was 39.6% (35.6, 44.9) in C1 and increased to 63.6% (56.7, 66.7) in C3 (P < .001). On intergroup analysis, a significant difference was observed between groups in C2 only (54.2 ± 7.1% vs. 45.6 ± 9.2%; P < .001), a finding that was mainly driven by a difference in physical examination score. On intragroup analysis, significant improvement in total score across time between cases was also observed. Intraclass correlation coefficients for each pair of assessors were excellent (0.885–0.996 [0.806, 0.998]) in all cases. Following participation, students’ confidence in comprehensive consultation assessments improved, and they felt more prepared for their future careers.ConclusionsHybrid simulation-based training improves competence and confidence in medical students undertaking comprehensive consultation assessment of cardiac patients. In addition, weighted scoring checklists improve grading consistency, learning through peer assessment, and feedback.Trial registrationClinicalTrials.gov Identifier: NCT05895799

A Web-Based Education Program About Primary Palliative Care for Heart Failure: A Study Protocol of Wait-Listed Randomized Controlled Trial.

The number of patients with heart failure (HF) is rapidly increasing as palliative care is being integrated into HF management and the need for a nursing workforce to meet these demands grows. To address this, we have developed a Web-based educational program on primary palliative care for HF among general registered nurses caring for patients with HF in Japan. The aim of this study was to evaluate the program's effectiveness on nurse-reported palliative care practice, difficulty, and knowledge. In this open-label, individual-level, wait-listed randomized controlled trial, 150 Japanese general registered nurses, with experience in caring for patients with HF and clinical ladder level ≥ 2 in inpatient, outpatient, and home-visiting care settings, will be randomly divided (1:1 ratio) into a Web-based educational program group and a wait-list control group. The follow-up period is 6 months after the intervention. The primary outcome is the nurse-reported practice score in primary palliative care, and the secondary outcomes are the nurse-reported difficulties score and knowledge score. We herein describe the study protocol of a wait-listed randomized controlled trial regarding a Web-based educational program, which is a novel approach for these nurses. If the results of this study support our hypothesis, they could help expand primary palliative care, including daily nursing practices, such as symptom management and interdisciplinary collaboration, in the field of cardiovascular nursing.

A randomized controlled trial for self-advocacy intervention in college students with disabilities.

People with disabilities often achieve lower educational attainments and face worse employment outcomes compared to the general population, a disparity partially due to the insufficient development of self-advocacy skills in academic and professional environments where targeted interventions are limited. This study designed and evaluated a 6-week self-advocacy program (SAP) enhanced with solution-focused brief therapy techniques for college students with disabilities (SWDs). A program evaluation on process and outcomes was conducted using a pilot randomized controlled trial with college SWD (n = 28). Process evaluations included feasibility, fidelity, and acceptability, whereas the preliminary impact was determined by comparing the outcome assessments of SAP and the control groups. Process findings indicated that the SAP was conducted as planned, with facilitators effectively employing solution-focused techniques. The program gained traction among SWD and proved feasible for implementation in college settings. SWD reported satisfaction with their participation and shared SAP's strengths as well as areas for improvement. Results indicated that SAP significantly increased SWDs' confidence in disclosing their disabilities and requesting accommodations in the workplace compared to their peers in the waitlist control group. However, no group differences were observed in self-advocacy and self-determination. The findings suggest that SAP offers benefits in various aspects of self-advocacy for college SWD, informing future implementations of SAP or similar initiatives targeting this group. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Telecoaching of Individuals With Multiple Sclerosis After Inpatient Multidisciplinary Rehabilitation: The Danish MS Hospitals Rehabilitation Study.

Inpatient rehabilitation improves health-related quality of life (HRQOL) for people with multiple sclerosis (MS). However, the obtained improvements decline once people return home. The challenge is to find ways to preserve the beneficial effects for the long term. We investigated whether monthly telecoaching after discharge would enhance the long-term carryover of improvements. We conducted a 1-year exploratory study with 2 delivery methods: telephone coaching and web-based coaching. After discharge, the telephone group received monthly calls; the web-based group responded to monthly online coaching questions. Based on their rehabilitation goals, we put patients into a neuropsychological group or a physical group. In addition, we matched each patient with similar wait-list control patients and treatment patients from the main study. The primary outcome was HRQOL measured by the Functional Assessment in Multiple Sclerosis (FAMS). The neuropsychological group had long-term preservation of HRQOL with both delivery methods, with telephone coaching seeming to be superior. Mean differences in FAMS at the 12-month median follow-up for the neuropsychological group compared with the control wait-list control group were for the telephone group: + 15.4 (95% CI, 3.5-27.4; P = .011); for the web-based group: + 10.9 (95% CI, -3.3 to 25.2; P = .130); for the control treatment group: + 6.9 (95% CI, 0.6-13.3; P = .031). The physical group saw no beneficial effects from telecoaching. Following inpatient multidisciplinary rehabilitation, monthly telecoaching of individuals with MS with neuropsychological challenges enhanced the long-term carryover of HRQOL, with one-on-one telephone coaching showing more pronounced improvements than web-based automated coaching.

A mixed methods, cluster randomized control trial to examine assistive technology use to support early literacy in preschool children with disabilities

This mixed methods study examined the impact of a multi-faceted professional development (PD) program for preschool teachers and classroom assistants on teacher-supported assistive technology (AT) use and early literacy development of children with disabilities. Four special education preschools were randomized into intervention (2 schools, 9 teachers, 50 children) and waitlist control (2 schools, 17 teachers, 42 children) groups. The 24-week PD included online modules, coaching, and AT device kits. Pre-post gains in children’s AT use and early literacy skills were analyzed using χ2 and repeated measures ANOVA. Teacher interviews and reflective commentaries were analyzed using Framework Analysis methodology. From pre- to post-test, the percent of children in the intervention group using some form of AT rose from 36 to 80%. The percent of children using AT in the control group went from 45 to 62%. The difference in change between the two groups was statistically significant, χ 2 = 13.93, p=.001. Gains in early literacy skills were not significantly different across groups, F(1,90)=0.010, p=.922. Analysis of the qualitative data revealed three themes: the positive impact of AT on child engagement and participation, the importance of individualizing AT for each student, and barriers teachers faced in AT implementation. The PD program had a positive effect on children’s AT use but not on gains in early literacy. Teachers’ comments highlighted the nuanced relationship between AT use and literacy outcomes, suggesting the need for more targeted implementation of AT during literacy activities.

Hatha yoga reduces momentary stress but does not impact diurnal profiles of salivary cortisol and alpha-amylase: A randomized controlled trial

Does the practice of yoga impact stress? Various studies have suggested that yoga may reduce both self-reported stress and stress biomarkers, but the evidence for such claims remains inconclusive, especially for yoga styles with a focus on physical postures. In a randomized controlled trial with 98 participants, we therefore examined whether an eight-week Hatha yoga intervention (60 min, 3×/week or more) led to reduced levels of diurnal salivary cortisol (sCort), salivary alpha-amylase (sAA), and subjective momentary stress as compared to a waitlist control group. To ensure the concomitant assessment of self-report and biological measures in an ecologically valid setting, and to capture the diurnal profile of cortisol and alpha-amylase, we employed an ecological momentary assessment approach. Five times per day, participants reported their momentary stress levels on a visual analogue scale and collected saliva samples for the assessment of salivary biomarkers. The intervention led to a significant reduction of subjective momentary stress but there was no change in diurnal sCort or sAA levels. There are several potential explanations for these findings: The intervention may have helped participants to cope better with stress while leaving diurnal levels of stress biomarkers unaffected, or the change may at least not have been reflected in sCort and sAA. Alternatively, there may have been a self-report bias, insofar as a favorable disposition towards yoga may have led participants to report reductions in stress in order to indicate positive effects of the intervention. Our findings contribute to a better understanding of the effects of distinct yoga interventions, demonstrating their potential to serve as low-risk stress relief tools.

A cluster-randomised controlled feasibility trial evaluating the Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS).

There is a high prevalence of cognitive difficulties in MS, but despite this, there are few programmes targeting cognition that focus on the ability to function well in everyday life. The Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), an occupation-focused cognitive intervention, was developed to address this. It addresses both the functional difficulties and the wide-ranging symptoms that present in MS. Here we report on the results of a cluster-randomised controlled feasibility trial (ISRCTN11462710; registered 4th September 2019) evaluating the COB-MS in terms of feasibility and initial efficacy as a cognitive intervention for people with MS. The eight-session COB-MS intervention was delivered remotely by occupational therapists to participants with MS in the intervention group. Following the end of the trial the COB-MS was delivered to the wait-list control group. Data was collected from people with MS experiencing cognitive difficulties at baseline, post-intervention, 12-weeks, and 6-month follow-up. The primary outcome measure was the Goal Attainment Scaling at 12weeks. Data was also collected in the domains ofcognition, quality of life, and mood. One hundred and eighteen people with MS and cognitive difficulties were randomised to either usual care (n = 60) or COB-MS intervention (n = 58). Ninety-four participants were retained at 6-month follow-up. The COB-MS was found to be feasible, including trial procedures and protocol. Data indicates that the COB-MS is accepted by participants and had positive impacts on daily life. Those allocated to the COB-MS group had a significant improvement in the primary outcome compared to the control condition. Progression criteria set for the feasibility trial have been met therefore further testing of the COB-MS at a definitive trial is supported by the results. The results provide a strong basis for a pathway to a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. ISRCTN11462710 Date of registration: 4th September 2019.

A Randomized Controlled Trial of a Virtually Delivered Group Parent Training for Parents of Children with ADHD During an Intensive Summer Treatment Program

ABSTRACT Background Behavioral Parent Training (BPT) is a widely implemented evidence-based treatment for youth with Attention-Deficit/Hyperactivity Disorder (ADHD) and related behavioral problems. During the COVID-19 pandemic, BPT was rapidly scaled for remote delivery via video conferencing platforms to enhance reach and engagement among families in need. Objective The purpose of the present study was to conduct a randomized controlled trial of a remotely delivered group-based BPT implemented in tandem with the Summer Treatment Program (STP) during the summer of 2021, the first year our clinic returned to in-person services following initial pandemic-related lockdowns. Method Children ranged in age from 6 to 12 years (M = 8.23, SD = 1.51) and were primarily male (93%) and Hispanic/Latine (74.4%). Families were randomly assigned to either receive the virtually delivered BPT during the summer (N = 23) or to a wait-list control group (N = 20), who received virtually delivered BPT in the fall. Results All families reported significant improvements in ADHD symptoms, related impairments, negative parenting behaviors, and knowledge of effective parenting skills from pre- to post-STP. Parents in the BPT group demonstrated additional improvements in managing difficult home situations. Conclusions Results of the study suggest that participating in BPT alongside the STP produces unique benefits for families above the standard behavioral treatment. Additionally, this study demonstrates the feasibility and utility of virtual group-based BPT to reduce burden associated with in-person services while providing evidence-based care in an inclusive manner.

Testing the Effectiveness of a Mobile Smartphone App Designed to Improve the Mental Health of Junior Physicians: Protocol for a Randomized Controlled Trial.

Shift (Black Dog Institute) is the first mobile health smartphone appcreated to support the mental health of junior physicians. Junior physicians experience demanding work conditions, leading to high levels of psychological distress and burnout. However, they are often concerned about the potential career impacts of seeking mental health support. The confidentiality and ease of access of digital interventions may be particularly suited to address these concerns. The Shift app provides therapeutic and psychoeducational content and strategies contextualized for the specific needs of physicians in training. App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians. This study aims to test, at scale, the effectiveness of Shift among junior physicians working in Australia using a randomized controlled trial design. The primary aim is to examine whether junior physicians using Shift experience a reduction in depressive symptoms compared with a waitlist control group. The secondary aim is to examine whether the app intervention group experiences improvements in anxiety, work and social functioning, help seeking, quality of life, and burnout compared with the control group. A total of 778 junior physicians were recruited over the internet through government and nongovernment medical organizations across Australia, as well as through paid social media advertisements. They were randomly allocated to one of 2 groups: (1) the intervention group, who were asked to use the Shift app for a period of 30 days, or(2) the waitlist control group, who were placed on a waitlist and were asked to use the app after 3 months.Participants completed psychometric measures for self-assessing mental health and wellbeing outcomes, with assessments occurring at baseline, 1 month after completing the baseline period, and 3 months after completing the baseline period. Participants in the waitlist control group were asked to complete an additional web-based questionnaire 1 month after receiving access to the app or 4 months after completing the baseline survey. Participants took part in the study on the internet; the study was completely automated. The study was funded from November 2022 to December 2024 by the New South Wales Ministry of Health. Data collection for the study occurred between January and August 2024, with 780 participants enrolling in the study during this time. Data analysis is underway; the effectiveness of the intervention will be estimated on an intention-to-treat basis using a mixed-model, repeated measures analysis. Results are expected to be submitted for publication in 2025. To the best of our knowledge, this is the first randomized controlled trial to examine the effectiveness of a mobile health smartphone app specifically designed to support the mental health of junior physicians. Australia and New Zealand Clinical Trials Registry ACTRN12623000664640; https://tinyurl.com/7xt24dhk. DERR1-10.2196/58288.

Intervention in Time Processing Ability and Everyday Functioning for Preschool Children in Need of Special Support: A Randomized Controlled Study

ABSTRACT Children in need of special support in preschool (INS) often exhibit delayed time processing ability (TPA) which can significantly impact their everyday functioning (EDF). This study evaluates whether the MyTime intervention could improve TPA and EDF in preschool children aged five to six-year INS. A registered randomized controlled trial (ISRCTN85136134) using a waiting-list control group investigated the effectiveness of MyTime, an occupational therapy intervention program given to preschool children INS in their classrooms for 8 weeks. Data collection included KaTid-Child® for the assessment of TPA, the Time-Parent scale, the Adaptive Behavior Assessment System, and the Autonomy scale for assessing EDF. To evaluate between-group differences, data were analyzed using linear regression. The results show that both groups improved from baseline to post-intervention in TPA and everyday functioning but at the post-intervention, there were no between-group differences. To summarize, the MyTime intervention, indicated an increase in TPA and EDF but no between-group differences were found. Early cognitive levels of TPA in preschool children INS advocate for a longer intervention period. It is possible that long-term follow-up or additional measuring of the teacher’s attitudes and the children’s engagement in the preschool context could have yielded other results.

A 10-week multicomponent outdoor exercise program improves hemodynamic parameters and physical fitness in cardiovascular disease adult and elderly patients

AbstractThis study aimed to assess the effects of a 10-week multicomponent outdoor exercise program on hemodynamic, physical fitness and psychological variables in subjects with CVDs. Twenty participants (12 M and 8 F; age 68.5 ± 8.6 years; BMI 28.49 ± 4.98 kg/m2) suffering from CVDs participated in this randomized controlled study and were allocated into two groups: an experimental group (EG; 6 M, 5 F) who underwent a multicomponent training (i.e., cardiorespiratory, resistance, mobility and breathing exercises; 60’, 2d·wk-1), or a wait-list control group (CG; 6 M, 3 F) who did not engage in any PA. Hemodynamic parameters were assessed through resting heart rate (RHR) and peripheral blood pressure (P-SBP/P-DBP). Physical fitness was assessed via a 30″ chair stand test (30CST), timed up and go (TUG) test, handgrip strength (HGS) test, and 2’ step test (TMST). The health status and quality of life (QoL) were evaluated with short form-12 (SF-12) and World Health Organization QoL (WHOQoL-bref), respectively. After the intervention, EG showed significant reduction in hemodynamic parameters (RHR p &lt; 0.001, ES = 0.98; P-SBP p &lt; 0.001, ES = 0.53; P-DBP: p &lt; 0.001, ES = 0.78), physical fitness (30CST p &lt; 0.001, ES = 0.92; TUG p = 0.001, ES = 0.67; TMST p &lt; 0.05, ES = 0.79) and physical component of SF-12 (PSC-12 p &lt; 0.05, ES = 0.42) compared to CG; no significant changes were observed in HGS, QoL and mental health component of the SF-12 (p &gt; 0.05). The findings showed significant improvements in hemodynamic parameters and physical fitness suggesting the effectiveness of the multicomponent outdoor exercise program in adults and elderly with stabilized CVDs.

Play With Me: Effects of a shared activities parenting intervention on parenting and relative reinforcing value of food

This pilot randomized controlled trial evaluated impacts of a novel shared activities intervention designed to promote positive parent-child interactions, which may function as an alternative reinforcer to food. The 4-week, at-home Play With Me intervention combines didactic parenting videos and play kits with materials for parent-child activities to practice skills. Aims of the present study were to examine the intervention's acceptability and its effects on parenting and the relative reinforcing value (RRV) of food versus parent-child activity at post-intervention. Thirty-two parents of 4-to-5-year-old children at risk for obesity were randomly assigned to the intervention or a waitlist control group. The intervention was well-liked by parents and feasible. Intervention parents reported more parenting structure and demonstrated higher observed sensitive parenting than controls at post; the latter finding was driven by greater parent positive mood, warmth, positive reinforcement, and relationship quality, with large effect sizes. There were no effects on the RRV of food. Inconsistent with hypotheses, there were trends toward control group parents reporting more parenting satisfaction and efficacy at post. Possible explanations are discussed. Results suggest Play With Me shows promise as an effective and acceptable intervention to promote positive parenting. Further research is needed to examine these effects and their implications for socioemotional development and health in a larger, more diverse sample over a longer time frame.

A - 24 Treatment Response to Internet-Delivered Cognitive Behavioral Therapy for Depression in Multiple Sclerosis

Abstract Objective A recent randomized-controlled (phase III) clinical trial examined the efficacy of an internet-delivered cognitive behavioral therapy (iCBT) intervention designed to treat depressive symptoms in persons with multiple sclerosis (PwMS). Significant mean reductions in depressive symptoms were found in the stand-alone iCBT and guided-iCBT conditions compared to the control group. The purpose of the current study was to identify the proportion of PwMS who responded to iCBT (stand-alone and guided) for depression compared to a waitlist control group. Method 224 PwMS completed the Beck Depression Inventory-II (BDI-II) to measure depression severity at baseline and post-intervention. Reliable change index (RCI) scores for depressive symptoms were calculated for each participant. Clinical significance was determined using the 95th percentile cutoff (RCI = ± 1.96). Results Combining the stand-alone and guided-iCBT (n = 147) groups, 89 PwMS (61%) demonstrated a reliable decrease in BDI-II scores, whereas 58 PwMS (39%) did not show a reliable decrease. For waitlist controls (n = 77), 19 PwMS (25%) showed a reliable decrease in BDI-II scores, χ2(2, N = 224) = 33.82, p &amp;lt; 0.001, φ = 0.39. Conclusions We found that the iCBT treatment was highly effective, with 61% of PwMS showing a reliable decline in depressive symptoms compared with only 25% of waitlist controls. Still, generally consistent with previous research, almost 40% of PwMS did not respond to iCBT for depression. Future work will investigate baseline cognitive, psychosocial, and disease-related predictors of response to iCBT to better understand treatment outcomes and possible targets to optimize interventions for depression in MS.

Transferability of an executive function intervention in children with cerebral palsy: A randomized controlled trial.

To evaluate the transfer effects of a home-based computerized executive function intervention on non-targeted cognitive functions (visual perception and memory), quality of life (QoL), and participation in children with cerebral palsy (CP), and to determine whether any improvements were maintained 9 months after the intervention. Sixty children with CP (aged 8-12 years) were randomly allocated to the intervention (15 females/15 males, mean age 10 years 4 months [SD = 1 years 8 months], age range 8-12 years) or waitlist (control) (15 females/15 males, mean age 10 years [SD = 1 years 9 months], age range 8-12 years) group. The intervention group underwent a home-based executive function intervention programme for 30 minutes per day, 5 days a week, for 12 weeks. All participants were assessed before the intervention, immediately after and 9 months after the intervention was completed. After the intervention was completed, performance in immediate verbal memory, verbal learning, and visual perception (object and picture recognition) was significantly better in the intervention group than in the waitlist (control) group. No improvements were found in visual memory, visuospatial perception, QoL, or participation after the intervention. Scores at the follow-up showed that any beneficial effects were not maintained 9 months after the intervention was completed. A home-based computerized executive function intervention produced transfer effects on memory and visual perception immediately after the intervention in children with CP, although any beneficial effects were not sustained at the 9-month follow-up.

Effectiveness of a parent-focused intervention targeting 24-hour movement behaviours in preschool-aged children: a randomised controlled trial

BackgroundInterventions focusing on individual behaviours (physical activity, sedentary behaviour, sleep) of preschool-aged children have been widely studied. However, there is a lack of understanding about integrated interventions that target all three 24-hour movement behaviours. This is the first study to assess the effectiveness of an intervention aimed at improving all three 24-hour movement behaviours among preschoolers in Hong Kong.MethodsA 12-week randomised controlled trial with a 12-week follow-up was conducted. Parent-child pairs were randomised to integrated approach (targeting all three behaviours), dyadic approach (targeting physical activity and sedentary behaviour including screen time), or wait-list control group. Utilising the Internet-based delivery, this intervention consisted of education materials, workshops, and interactive questionnaires and reminders. Two intervention groups employed the same strategies, with the only difference being that the integrated approach targeted sleep in addition to physical activity and sedentary behaviour. The outcomes were preschoolers’ overall 24-hour movement behaviours which were assessed by the Activity Sleep Index (ASI), movement behaviour composition, and absolute duration of movement behaviours. Generalised estimating equations were conducted to evaluate the intervention.ResultsA total of 147 preschoolers (4.8 ± 0.9 years old, 56.5% boys) and their parents were included. Preschoolers in all groups had a lower ASI at follow-up compared with baseline. Preschoolers in the integrated approach had a smaller decline in ASI at follow-up, compared to that in the control group (3.41; 95% confidence interval [CI] = 0.07, 6.76). Preschoolers in both intervention groups had a smaller reduction of the composition of time spent in physical activity at follow-up, and a decreased screen time at postintervention and follow-up. No significant differences were found for the sleep subcomponent. Furthermore, preschoolers in the dyadic approach had a smaller increase in the sedentary behaviour subcomponent (vs. control: − 0.21; 95% CI = − 0.37, − 0.05) at follow-up.ConclusionsBoth intervention groups showed a decrease in screen time at postintervention, but there were no significant changes in other behaviours. The favourable changes observed at follow-up demonstrated the effectiveness of both intervention approaches on alleviating the decline in the composition of time spent in physical activity and reducing screen time and revealed the possible effectiveness of the integrated approach in promoting overall movement behaviours among preschoolers.Trial registrationThe study is prospectively registered at the Chinese Clinical Trial Registry (ChiCTR2200055958).

Effects of a nurse-led staged integral art-based cognitive intervention for older adults on the Alzheimer's disease spectrum: A randomized controlled trial

BackgroundCombined art activities can improve the neural network function within various brain regions involved in emotions, cognition, and behavior, thereby preventing or reversing cognitive decline. However, few studies have systematically examined its effects. Furthermore, the impact of nurse-led art-based cognitive intervention on cognitive and psychological health is unclear. ObjectiveTo evaluate the effects of a nurse-led staged integral art-based cognitive intervention in older adults on the Alzheimer's disease spectrum. DesignThis was a randomized wait-list controlled trial with allocation concealment and blinding of outcome assessors and data analysts. All data were collected between April 2021 and January 2023 and analyzed from January to March 2023. SettingOne memory clinic and four medical partnership communities. ParticipantsA total of 144 participants with subjective or objective memory decline (aged ≥60 years). MethodsParticipants were randomized into an intervention group (n = 72) and a wait-list control group (n = 72), in a 1:1 ratio. The intervention group underwent a 16-week, 24-session nurse-led staged integral art-based cognitive intervention program, which was based on neurocognitive function training patterns. The control group underwent the program after the follow-up assessment. General and specific domains of cognitive function and other health-related outcomes were measured at baseline (T0), immediately after the intervention (T1), and at the 6-month follow-up (T2). ResultsOf the 144 participants (mean [SD] age, 71.6 [5.8] years; 50 [34.7 %] males and 94 [65.3 %] females), 130 and 115 completed the questionnaires at T1 and T2, respectively. The average attendance rate in the intervention group was 86.0 %. At T1, the intervention group showed greater improvement than the control group did in general cognitive functions (MoCA, between-group mean difference, 1.4 [95 % CIs, 0.4 to 2.5], p = 0.009). Additionally, the intervention group demonstrated statistically significant improvement compared to the control group in language, memory, quality of life, sleep quality and physical activity level at T1. Statistically significant group differences remained in sleep quality (PSQI, between-group mean difference, −1.3 [95 % CIs, −2.5 to −0.1], p = 0.035) at the 6-month follow-up. ConclusionsIn this randomized controlled trial of a nurse-led staged integral art-based cognitive intervention program, older adults on the Alzheimer's disease spectrum who participated in the program experienced improved cognition and psychological health. RegistrationThis study was registered with ChiCTR.org (ChiCTR2100044959) on April 3, 2021. Tweetable abstractA nurse-led staged integral art-based intervention for older adults on the Alzheimer's disease spectrum experienced improved cognition and psychological health.

A mixed-method randomised controlled feasibility trial of digital CBT and emotion regulation skills training for employees in the workplace (REST)

Background and aimDigital interventions for depression and anxiety can be as effective as face-to-face therapy. One in six workers experience some form of mental health problems, making the workplace a potential avenue to deliver mental health interventions as part of a stepped care model. This study aimed to assess the acceptability, feasibility, and preliminary efficacy of a digital cognitive behavioural therapy (dCBT) on depression and anxiety for employees in the workplace.MethodsA mixed-methods evaluation of employees allocated to dCBT (n=25), or a waitlist control group (n=27) was used to assess five feasibility objectives related to recruitment of employers and employees, engagement, study procedure and preliminary efficacy of the intervention. Quantitative outcome measures and qualitative interviews at 8 weeks post-randomisation were used. Quantitative outcomes were also assessed within subject at 3-, 6-, and 12-month follow-up. Qualitative data was analysed using thematic and framework analysis in Nvivo, whilst quantitative outcomes were analysed using mixed effect linear models between and within subject in R and SPSS.ResultsThirty-Three businesses agreed to facilitate the delivery of three trials run by the University of Warwick in their workplaces. 52 participants consented into the REST trial. Adherence/usage of participants of the treatment platform was just over 50% across the whole sample. There was a reduction in depression and anxiety symptoms post-intervention and at follow-up timepoints across all participants and over time although there were no statistically significant between group differences. High acceptability and satisfaction of the intervention were reported by participants based on qualitative interview data at post-intervention.ConclusionsResults from this feasibility study suggests that the dCBT programme (REST) was acceptable and shows improvement in depression and anxiety symptoms, albeit not over and above the treatment effects in the control group. Recruitment of participants and engagement with the intervention made the feasibility of the delivery somewhat challenging. With better recruitment promotion and engagement strategies, as well as implementing the learnings from the feasibility trial, a fully powered study can inform the efficacy of the REST intervention.Trial registrationThe study is registered in the BMC Springer Nature ISRCTN registry ISRCTN31161020 (registered on 08/06/2021).

Does MATmatics Work? Impact of Early Numeracy Intervention on Students’ Math Skills

Early knowledge of numbers, relations, and operations are foundations for student success. Weak foundational number skills can lead to later difficulties, thus early identification and targeted interventions for students with weak number skills can help stop them from falling further behind. In the current study, we tested the effectiveness of MATmatics, a tier 2 intervention that targeted early numeracy skills for at-risk students in grades 2 and 3. Students (N = 45) were quasi-randomly assigned to either an intervention group, or a wait-listed control group. Using a series of 2 (group: intervention, control) x 2 (test timing: pre-intervention, post-intervention) mixed ANOVAS, we found that the math skills (measured with the Early Math Assessment@School numeracy screener) of students assigned to the intervention group improved at a faster rate than the math skills of their waitlisted control peers. The intervention was effective.

Long-Term Effects of Individualized Acupuncture for Chronic Neck Pain : A Randomized Controlled Trial.

Long-term effects of individualized acupuncture in persons with chronic neck pain (CNP) remain unknown. To evaluate the efficacy and safety of pressure pain, sensory-based individualized acupuncture for relieving CNP. A 24-week multicenter randomized controlled clinical trial. (ChiCTR1800016371). Outpatient settings at 4 clinical centers in China from May 2018 to March 2020. 716 participants with CNP. Participants were randomly assigned to a waiting list (WL) group or to 1 of 3 interventions, which consisted of 10 sessions over 4 weeks: higher sensitive acupoints (HSA), lower sensitive acupoints (LSA), and sham acupoints (SA) acupuncture groups. The primary outcome was the change in the visual analogue scale (VAS) score for neck pain (range, 0 to 100) from baseline to 4 weeks, with a difference of 10 points considered the minimum clinically important threshold. The VAS was also assessed every 4 weeks through 24 weeks. The modified intention-to-treat population included 683 participants. The mean baseline VAS was 50.36, 50.10, 49.24, and 49.16 for HSA, LSA, SA, and WL, respectively. Compared with a mean baseline to week 4 change of -12.16 in the HSA group, the mean changes were -10.19 in the LSA group (net difference [ND], -1.97 [95% CI, -5.03 to 1.09]), -6.11 in the SA group (ND, -6.05 [CI, -9.10 to -3.00]), and -2.24 in the WL group (ND, -9.93 [CI, -12.95 to -6.90]). The intervention effects persisted at 24-week follow-up. Lack of complete blinding and limited generalizability. Individualized acupuncture interventions using high- or low-sensitivity acupuncture points were more effective in reducing CNP than SA and WL control groups sustained through 24 weeks, but the magnitude of relative improvement did not reach a minimal clinically important difference. National Natural Science Foundation of China.

Improving sleep health in paramedics through an app-based intervention: a randomised waitlist control pilot trial

BackgroundDue to work commitments, shiftworkers often obtain inadequate sleep, consequently experiencing negative health, wellbeing, and safety outcomes. Given shiftworkers may have limited control over their work commitments, lifestyle and environmental factors within their control may present an intervention opportunity. However, such interventions require tailoring to ensure applicability for this sleep-vulnerable population.MethodsA randomised waitlist control pilot trial investigated the effectiveness of mobile health application Sleepfit, which delivered a tailored sleep health intervention aimed at improving sleep health and sleep hygiene outcomes amongst paramedic shiftworkers. Outcome measures of self-reported sleep health (sleep need, duration, and quality, fatigue, Insomnia Severity Index, Fatigue Severity Scale, and Epworth Sleepiness Scale scores) and sleep hygiene (Sleep Hygiene Index score) were collected at baseline, post-intervention, and 3-month follow-up.ResultsFifty-eight paramedics (aged 33.4 ± 8.0 years; 50% male) were recruited, and trialed Sleepfit for a 14-day intervention period between August 2021–January 2022. For all participants, there was a significant reduction in Insomnia Severity Index and Sleep Hygiene index scores after intervention engagement. Regression models demonstrated no significant intervention effect on sleep health or sleep hygiene outcomes (intervention versus waitlist control group). A high study drop-out rate (91.4%) prevented assessment of outcomes at 3-month follow-up.ConclusionsPilot trial findings demonstrate that Sleepfit may elicit improvements in sleep health and sleep hygiene outcomes amongst paramedic shiftworkers. However, low enrolment and retention means that findings should be interpreted with caution, further highlighting potential engagement challenges, especially among paramedics who are particularly in need of support for improved sleep.Trial registrationProspectively registered with the Australian New Zealand Clinical Trial Registry 24/01/2020 (reference no. ACTRN12620000059965).