Wait-list Control Group Research Articles

The Effects of a School-Based Mindfulness Programme (Paws b) on Empathy and Prosocial Behaviour: A Randomised Controlled Trial

ObjectivesThe purpose of this study was to examine the effects of a school-based mindfulness programme (SBMP), “Paws b”, on empathy and prosocial behaviour among children aged 7 to 10 years in a school setting.MethodThis multi-informant design, randomised controlled trial compared an intervention group to a wait-list control group, involving 133 children aged 7- to 10 years from 10 classrooms. Outcome measures were taken at pre-intervention, post-intervention, and 3-month follow-up and included self-reports of mindfulness and empathy, a sharing task, teacher and peer reports of prosocial behaviours, and sociometry measures.ResultsChildren in the intervention group were voted as significantly more (a) prosocial by teachers F(1, 127) = 7.35, p = 0.008, η2 = 0.055, (b) helpful by peers, F(1, 127) = 9.369, p < 0.003, η2 = 0.069, (c) popular by peers, F(1, 127) = 4.90, p = 0.028, η2 = 0.037, and (d) showed more reciprocal relationships, t(8) = 2.518, p = 0.036, compared to the wait-list control group. The intervention did not have an effect on mindfulness scores, empathy scores (affective, cognitive, or intention to comfort), or sharing task scores.ConclusionsFindings suggest that, for 7–10-year-olds, the SBMP, Paws b, delivered by a mindfulness teacher, can increase some aspects of prosociality, as judged by peers and teachers, but has no effect on self-assessed empathy.PreregistrationThis study was preregistered on the Open Science Framework (https://osf.io/vm6tp/) on 31.10.2022.

Resistance training's impact on blood biomarkers and cognitive function in older adults with low and high risk of mild cognitive impairment: a randomized controlled trial

BackgroundThe aging brain exhibits a neuroinflammatory state, driven partly by peripheral pro-inflammatory stimuli, that accelerates cognitive deterioration. A growing body of evidence clearly indicates that physical exercise partly alleviates neuroinflammation and positively affects the aging process and cognition. In this randomized controlled trial, we aimed to observe the effect of 12 weeks of resistance training (RT) on peripheral biomarker levels, cognitive function changes and their interrelationship, and explore differences in those exercise-induced changes in older adults with high risk of mild cognitive impairment (MCI) compared to older adults with low risk of MCI.MethodsFifty-two participants (aged 60–85 years old, 28 female) were randomly allocated to a 12 week lower limb RT program consisting of two training sessions per week or waiting list control group. The Montreal Cognitive Assessment (MoCA) was used to stratify participants screened as high (< 26/30) or low risk (≥ 26/30) of MCI. We assessed serum Interleukin 6 (IL-6), Insulin-like Growth Factor-1 (IGF-1), and Kynurenine (KYN) levels. Cognitive measurement consisted of and four subtests of Automated Neuropsychological Assessment Metrics (ANAM), the two-choice reaction time, go/no-go, mathematical processing, and memory search test.ResultsTwelve weeks of RT improved Go/No-go test results in older adults with high MCI risk. RT did not significantly affect blood biomarkers. However, IGF-1 level increases were associated with improvements in response time on the mathematical processing test in the exercise group, and IL-6 level increases were associated with improvements in response time on the memory search test in the total group of participants. Finally, KYN levels significantly differed between older adults with low and high MCI risk but no significant associations with performance were found.ConclusionOur study results suggest a different effect of RT on inhibitory control between older adults with low compared to high MCI risk. IGF-1 may play a role in the mechanism behind the cognitive benefit of RT and KYN may be a surrogate biomarker for neurodegeneration and cognitive decline.

Indicated Stress Prevention Addressing Adolescents with High Stress Levels Based on Principles of Acceptance and Commitment Therapy: A Randomized Controlled Trial

Introduction: Stress affects many adolescents and is associated with physical and mental health symptoms that can have a negative impact on normative development. However, there are very few evidence-based, specific treatment approaches. The aim of the study was to investigate an eight-session group intervention using components of Acceptance and Commitment Therapy (ACT) enriched with elements of CBT (psychoeducation, problem solving) and art therapy, compared to a waitlist control (WLC) group, regarding its efficacy in reducing stress and associated symptoms. Methods: We conducted a randomized controlled trial in eight cohorts. Eligible participants were 13–18 years old with elevated stress levels. Via block-randomization (n = 70), participants were allocated to receive ACT (n = 38) or WLC (n = 32) and subsequent ACT. We used a multimodal assessment (self-reports, interviews, ecological momentary assessment, physiological markers) before treatment (T1), after the training of the ACT group (T2) and after subsequent training in the WLC group (T3). Primary outcome was perceived stress at T2 assessed with the Perceived Stress Scale. The trial was preregistered at the German Clinical Trials Register (ID: DRKS00012778). Results: Results showed significantly lower levels of perceived stress in the ACT group at T2, illustrating superiority of ACT compared to WLC with a medium to large effect size (d = 0.77). Furthermore, the training was effective in the reduction of symptoms of school burnout and physical symptoms associated with stress. Conclusion: Indicated prevention, especially when based on the principles of ACT and CBT, seems efficient in significantly decreasing stress in adolescents with increased stress.

Efficacy of a web-based psychoeducational intervention, Fex-can sex, for young adult childhood cancer survivors with sexual dysfunction: A randomized controlled trial

BackgroundNo web-based interventions addressing sexual problems are available for young adult survivors of childhood cancer. AimThis study aimed to test the efficacy of a web-based psychoeducational intervention, Fex-Can Sex, to alleviate sexual problems in young adults treated for cancer during childhood. MethodThis randomized controlled trial tested the effects of a 12-week, self-help, web-based intervention. Young adults (aged 19–40) reporting sexual dysfunction were drawn from a population-based national cohort of childhood cancer survivors and randomized to either an intervention group (IG, n = 142) or a wait-list control group (CG, n = 136). The primary outcome was ‘Satisfaction with sex life’ assessed by the PROMIS® SexFS v 2.0. Secondary outcomes included other SexFS domains, body image (BIS), emotional distress (HADS), health-related quality of life (EORTC QLQ-C30), and sex-related self-efficacy. Surveys were completed at baseline (T0), directly after the intervention (T1), and three months later (T2). The effects of the intervention were tested using t-test and linear mixed models, including intention-to-treat (ITT) and subgroups analysis. Adherence was based on log data extracted from the website system. The intervention included an open-ended question about perceived sexual problems. ResultsNo effect of the intervention was found in the primary outcome. Regarding secondary outcomes, the IG reported less vaginal dryness (Lubrication subscale) than the CG at T1 (p = 0.048) and T2 (p = 0.023). Furthermore, at T1, the IG reported less emotional distress than the CG (p = 0.047). Subgroup analyses showed that those with greater sexual problems at T0 improved over time (T1 and T2), regardless of group allocation. Overall, adherence to the intervention was low and participants' activity levels did not change the results. Additionally, some members of the IG reported increased understanding and acceptance of their sexual problems. ConclusionThe Fex-Can Sex intervention shows potential to improve sexual function, especially among those with greater dysfunction. To increase adherence and effect, we recommend the intervention to be further developed including more tailored content. Clinical trial registrationISRCTN Registry, trial number: 33081791 (registered on November 27, 2019).

Effects of a Serious Smartphone Game on Nursing Students' Theoretical Knowledge and Practical Skills in Adult Basic Life Support: Randomized Wait List-Controlled Trial.

Retention of adult basic life support (BLS) knowledge and skills after professional training declines over time. To combat this, the European Resuscitation Council and the American Heart Association recommend shorter, more frequent BLS sessions. Emphasizing technology-enhanced learning, such as mobile learning, aims to increase out-of-hospital cardiac arrest (OHCA) survival and is becoming more integral in nursing education. The aim of this study was to investigate whether playing a serious smartphone game called MOBICPR at home can improve and retain nursing students' theoretical knowledge of and practical skills in adult BLS. This study used a randomized wait list-controlled design. Nursing students were randomly assigned in a 1:1 ratio to either a MOBICPR intervention group (MOBICPR-IG) or a wait-list control group (WL-CG), where the latter received the MOBICPR game 2 weeks after the MOBICPR-IG. The aim of the MOBICPR game is to engage participants in using smartphone gestures (eg, tapping) and actions (eg, talking) to perform evidence-based adult BLS on a virtual patient with OHCA. The participants' theoretical knowledge of adult BLS was assessed using a questionnaire, while their practical skills were evaluated on cardiopulmonary resuscitation quality parameters using a manikin and a checklist. In total, 43 nursing students participated in the study, 22 (51%) in MOBICPR-IG and 21 (49%) in WL-CG. There were differences between the MOBICPR-IG and the WL-CG in theoretical knowledge (P=.04) but not in practical skills (P=.45) after MOBICPR game playing at home. No difference was noted in the retention of participants' theoretical knowledge and practical skills of adult BLS after a 2-week break from playing the MOBICPR game (P=.13). Key observations included challenges in response checks with a face-down manikin and a general neglect of safety protocols when using an automated external defibrillator. Playing the MOBICPR game at home has the greatest impact on improving the theoretical knowledge of adult BLS in nursing students but not their practical skills. Our findings underscore the importance of integrating diverse scenarios into adult BLS training. ClinicalTrials.gov (NCT05784675); https://clinicaltrials.gov/study/NCT05784675.

Abstract CT272: A cluster randomized trial to evaluate a church-based navigation model to increase breast cancer screening in Korean women (Faith In Action!): Trial in progress

Abstract Background: Breast cancer is the most commonly diagnosed cancer among Korean American women and incidence in this group is rising. Advanced-stage disease is more frequent among Korean women diagnosed with breast cancer than in other ethnicities due to low adherence to screening. Lower socioeconomic status, cultural barriers, perceived norm, distrust of healthcare system, and lack of awareness and culturally tailored communication on benefits of screening contribute to low screening utilization. Church settings offer important platforms for education as a majority of Korean American women &amp;gt;50 years regularly attend church services. Thus, the objective of this trial was to evaluate the efficacy of a culturally tailored intervention “Faith in Action!” on breast cancer screening adherence rates among Korean American women. Methods: A parallel cluster randomized trial with staggered roll-out will be conducted to evaluate the efficacy of the “Faith in Action!” intervention, a church-based small group education and lay health navigator program, delivered by trained church members, on breast cancer screening among Korean American women (NCT05298605). This study was designed and conducted in partnership with a Community Advisory Board. Trial enrollment began in July 2022 and is ongoing. Twenty-four total Korean churches in Los Angeles were randomized within blocks of 8 churches to either intervention or waitlist control conditions in a 1:1 ratio. Using a train-the-trainer approach, lay navigators from the Korean Church community nominated by church leadership are trained and certified to deliver the Faith in Action! intervention to study participants over a 6-month program period. Participants at churches randomized to the waitlist control group receive an educational presentation on physical activity and nutrition and, after 6-month follow-up, are invited to receive the Faith in Action! intervention. Eligible participants include women of Korean descent, ages 45-75 years, who: attend a participating church, do not have a breast cancer diagnosis, and did not receive mammogram in the last 2 years. The primary outcome is adherence to breast cancer screening guidelines within 6 months from end of program. Secondary outcomes include adherence to breast cancer screening within 1 year and participant knowledge about breast cancer screening practices. Qualitative interviews will be conducted to assess participants’ knowledge and barriers surrounding cancer screening decisions and program acceptability. To date, 16 churches (149 total participants) have been enrolled in the study and are being followed. It is expected that findings from this research will inform community-based efforts to increase breast cancer screening adherence among Korean American women and improve understanding of screening barriers in this group that is disproportionately impacted by breast cancer, while building capacity and opportunities for sustainability in the Korean faith community. Citation Format: Gillian Gresham, Christie Y. Jeon, Dong Hee Kim, Min Jung Sung, Laurel J. Finster, Marcio A. Diniz, Michael Fine, Zul Surani, Alison K. Herrmann, Jeong Yup Lee, Robert W. Haile. A cluster randomized trial to evaluate a church-based navigation model to increase breast cancer screening in Korean women (Faith In Action!): Trial in progress [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT272.

Do Character Strengths-Based Interventions Change Character Strengths? Two Randomized Controlled Intervention Studies

Character strengths-based interventions are effective for increasing well-being. However, whether such interventions also change character strengths has never been tested. In Study 1, we studied the effects of seven different variants of character strengths-based interventions on well-being, ill-being, and character strengths traits and states (i.e., frequency of behavior during one week). We analyzed data of N = 1,163 participants (82.3% women, aged 18 to 78; Md = 45) who were randomized to seven intervention conditions lasting one week; (1) learning about the VIA classification of character strengths, (2) learning about one’s own strengths, using signature strengths (3) in a new way, (4) with a minor challenge, (5) with a larger challenge, (6) for other people, (7) forming a strengths-based habit, or a placebo control condition (early memories). Results showed that using signature strengths in a new way led to increased well-being, social well-being, as well as character strengths states and traits. Forming a strengths-based habit also increased well-being and character strengths states. No effects on ill-being were found. In Study 2, we tested a four-week multi-component program that combined several interventions tested in Study 1 in a sample of N = 254 participants (77.8% women, aged 19 to 87; Md = 42). Compared to a waitlist control group, the intervention condition showed increases in well-being and character strengths states, and reductions in stress and neuroticism. We conclude that character strengths interventions may not only affect well-being but also character strengths states and traits, as well as broader personality traits such as neuroticism.

Web-Based Emotion Regulation Training for Sexual Health: Randomized Controlled Trial.

Effective emotional regulation (ER) skills are important for sexual function, as they impact emotional awareness and expression during sexual activity, and therefore, satisfaction and distress. Emotion regulation interventions may offer a promising approach to improve sexual health. Web-based emotion regulation may be a therapeutic strategy for men and women with sexual health concerns. Nevertheless, there is a scarcity of intervention trials investigating its effects in this context, much less using the internet. This study aims to investigate the effects of a web-based emotion regulation training program for sexual function in both men and women. The participants were recruited based on their self-reported sexual problems, which for men was defined by a score of <25 on the International Index Erectile Function (IIEF) and for women by a score of <26.55 on the Female Sexual Function Index (FSFI). The final sample included 60 participants who were randomized to either a web-based emotion regulation training for sexual function or to a waitlist control group. The treatment consisted of an 8-week web-based emotion regulation training for sexual function. The participants were assessed at baseline, post intervention, and the 3-month follow-up. Of the 60 participants included, only 6 completed all 3 assessment points (n=5, 20% in the treatment group and n=1, 5% in the waitlist control group) after receiving the intervention. At follow-up, there were no significant differences between groups in any measure. Among the intervention completers, large-to-moderate within-group effect sizes were observed between the assessment points on measures of emotion regulation, depression, lubrication, orgasm, thoughts of sexual failure, and abuse during sexual activity. The adherence rate was very low, limiting the generalizability of the findings. Participants who completed the intervention showed improvements in both sexual function domains and emotion regulation. Nonetheless, due to a high dropout rate, this trial failed to collect sufficient data to allow for any conclusions to be drawn on treatment effects. ClinicalTrials.gov NCT04792177; https://clinicaltrials.gov/study/NCT04792177.

Retention rates and reasons for non-retention in exercise oncology trials in the post-treatment phase-a systematic review.

Retention is a key marker of trial success. Poor retention can induce bias, reduce statistical power and minimise the validity of trials. This review examined retention rates in exercise trials in cancer survivors, reasons for non-retention and retention strategies utilised. A systematic review was conducted using a predefined search strategy in EMBASE RCTs, MEDLINE OVID, CINAHL, Web of Science-Core Collection and Cochrane Central Register of Controlled Trials (CENTRAL). The search was conducted on 27/03/2023. Title and abstract screening, full text review and data extraction were completed in duplicate. Of 17,524 studies identified, 67 trials involving 6093 participants were included. The median overall retention rate immediately post-intervention was 89.85%, range (52.94-100%) and mean 87.36% (standard deviation 9.89%). Trials involving colorectal cancer survivors only had the highest median retention rate (94.61%), followed by breast (92.74%), prostate (86.00%) and haematological cancers (85.49%). Studies involving mixed cancer cohorts had the lowest retention rate (80.18%). The most common retention strategies were wait-list control groups, regular check-ins/reminders and free exercise equipment. Common reasons for non-retention were lost to follow-up, health problems, personal reasons including family/work commitments and travel burden, and disease progression. Retention rates in exercise oncology trials are approximately 90% immediately post-interventions. Our previous work highlighted variable suboptimal recruitment rates of median 38% (range 0.52-100%). Recruitment rather than retention should be prioritised for methodology research in exercise oncology. Optimising the quality of exercise oncology trials is critical to informing high quality survivorship care. PROSPERO registration number: CRD42023421359.

499 Physiological and Metabolomic Effects of a Community-Based Cardiorenal Protective Diet Intervention in African Americans with Chronic Kidney Disease and Hypertension

OBJECTIVES/GOALS: Chronic kidney disease (CKD) impacts 15% of US adults and African American (AA) persons are disproportionately affected with more than 3 times higher risk of kidney failure when compared to Caucasian persons. This study evaluated the physiological and metabolomic effects of increased fruits and vegetables (F&amp;V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&amp;V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&amp;V compared to a wait-list control (WL) condition (N=45). All participants were African American adults (≥18 years), had self-reported hypertension, and had CKD (Stage 1-3) on screening spot-urine microalbumin test. Participants were measured at baseline and 6 weeks post-intervention. Clinical data (i.e., systolic and diastolic blood pressure, lipid panel, hemoglobin A1C, BMI [body mass index], and albumin to creatinine ratio) were collected. Targeted metabolomic quantitative analysis was performed followed by LC-MS/MS and FIA-MS/MS. Linear mixed models evaluated analyte expression and clinical data. RESULTS/ANTICIPATED RESULTS: AA participants (N=91) were aged 58 ± 10.2 years, 66% female, and 54% had incomes ≤$50,000. T-tests compared change scores (baseline to 6-weeks) between groups. The F&amp;V group demonstrated a significant reduction in BMI of -4.7 ± 10.5 kg/m² compared to a 1.9 ± 8.3 kg/m² increase in the WL group, p&lt;.01. Further, the F&amp;V group demonstrated a reduction in total cholesterol of -15.4 ± 58.8 mg/dL compared to a 17.7 ± 68.8 mg/dL increase in the WL group, p&lt;.05. Non-significant reductions in hemoglobin A1c were found in the F&amp;V versus the WL group. Metabolomic analysis indicated significant variation with an increase of suggestive key biomarkers for worse CKD in the WL versus F&amp;V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&amp;V via a community-based intervention reduced CVD risk factors in AA adults with CKD and HTN and resulted in molecular/biochemical changes which may improve long-term kidney health. Further investigation may lead to development of cost-effective dietary intervention models to improve CKD outcomes in AA persons.

Codesigned online cognitive bias modification of interpretations for anxiety and depression in children: study protocol of a randomised controlled trial

IntroductionPrevious research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety...

Effectiveness of an abbreviated version of the automated attention training technique (ATT) for stress reduction in a non-clinical sample—A randomized controlled trial

Stress is one of the leading risk factors for mental health problems. The attention training technique (ATT), developed in the context of metacognitive therapy, is a method for increasing flexible control of attention and might thus reduce the impact of stressful events on mental health. Developed as a 12-min exercise, ATT is primarily used in a clinical context. To ensure low-threshold implementation by the general population in everyday life, we developed an abbreviated 5-min version of the ATT. The present study examined the effectiveness of this abbreviated ATT in reducing stress in a three-armed randomized controlled trial by comparing the abbreviated version (ATTabbr; n = 74) with the long version (ATTlong; n = 67) and a waitlist control group (WCG; n = 77) in a non-clinical sample. The primary outcome was change on the Depression, Anxiety, and Stress Scale (DASS-21). In the intention-to-treat analysis of changes from baseline to follow-up, both the abbreviated ATT version and the long ATT version were superior to the WCG in the reduction of stress (d = 0.67 for the abbreviated version and d = 0.44 for the long version). From post to follow-up, reductions in stress were greater for the abbreviated version than the long version (d = 0.37). We also observed effects of both ATT versions on depression and anxiety but no effect on attention control, perseverative thinking, or quality of life. For the abbreviated version, we found preliminary evidence of a dose-response relationship. Participants with access to the abbreviated version conducted the training twice as often compared with those with access to the long version. These results suggest that the abbreviated version of the ATT is associated with greater adherence and possibly greater effects on stress than the long version. If these results are confirmed, the abbreviated version could be used to reduce stress and increase mental well-being in the general population.

Randomized controlled trial investigating the role of yoga at workplace in improving fatigue, burnout, pain, strength, and quality of life among blue-collar workers.

Due to the physical demands of work, blue-collar workers (BCW) frequently experience fatigue, musculoskeletal pain, and burnout. The purpose of this study was to determine the feasibility and utility of introducing yoga-based loosening exercises (YLE) at the workplace for improving fatigue, musculoskeletal pain, and burnout among BCW. One hundred and twenty-eight BCW were randomized into a yoga group that received 40 minutes of supervised YLE daily, 5 days a week, for 1 month, followed by 1 month of unsupervised practice at home or a waitlisted control group. The Chalder Fatigue Scale (CFS), Visual Analog Scale for pain, Oldenburg Burnout Inventory (OLBI), sit-and-reach test (SRT), handgrip strength dynamometer, and the Short Form-8 (SF-8) questionnaire were measured at baseline, at the end of the first month, and at follow-up after the first month. All the participants adhered well to the YLE (≈86% at the workplace, ≈70% at home). Compared to the controls, the yoga group reported significant reductions in fatigue, pain, and burnout and significant improvements in flexibility, strength, and quality of life (P < 0.001) at all the time points. Our findings demonstrate that workplace yoga programs for BCW are feasible and can considerably reduce fatigue, pain, and burnout and improve their quality of life.

Significant beneficial effects of 12-weeks add-on yoga therapy on antipsychotic-stabilized schizophrenia patients through epigenetic modulation: novel findings from a randomized controlled study

IntroductionComplementary and alternative therapy, especially yoga, is emerging as an important treatment modality for various complex disorders. Yoga therapy has reportedly been demonstrated to exhibit clinical benefits in schizophrenia. However, the modulatory effects of yoga therapy on the pathobiological pathways of schizophrenia are inadequately explored. Immune dysregulation is a widely recognized etiopathological construct of schizophrenia. It is not precisely known whether yoga therapy can modulate the expression of immune molecules by regulating gene expression and epigenetic processes in schizophrenia.ObjectivesTo understand the impact of 12-weeks add-on yoga therapy on the immune-inflammatory pathway in schizophrenia by examining plasma levels and gene expression levels of cytokines and complement proteins as well as by profiling promoter DNA methylation pattern of genes coding for cytokines and complement proteins.MethodsFifty-seven schizophrenia patients fulfilling DSM-V criteria were recruited into the study and randomized into Yoga therapy (n=28) and waitlist control (n=29) groups. Plasma levels of IL-1β, IL-6, IL-10, IL-17, C1q, C2, C3, C4, C5, C5a, Factor B and Factor H by Multiplex Suspension Assay, quantification of gene expression of Il1b, Il6, Il10, IL17, C3, C4 and C5 genes by quantitative PCR and promoter DNA methylation of Il1b, Il6, Il10, Il17, C3, C4 and C5 genes by pyrosequencing were carried out in all the study participants.ResultsPlasma levels of IL-1β (Z score= 2.42, p=0.02) dropped significantly and C2 (Z score= 2.24, p=0.03) levels increased after 12-weeks of yoga therapy. The expression of Il1b (Z score=2.45, p=0.01) and Il6 (Z score=2.07, p=0.04) genes were significantly downregulated, while the levels of C4 (Z score=2.23, p=0.03) gene was upregulated in schizophrenia patients of yoga therapy group. Two CpG sites in the promoter region of Il1b (all p≤0.05) and Il6 (all p≤0.05) genes and three CpG sites in the promoter region of C4 (all p&lt;0.05) gene were hypermethylated, while two CpG sites in the gene body of Il6 (all p≤0.05) gene and two CpG sites in the promoter region of Il10 (all p ≤0.05) gene were hypomethylated after 12-weeks of yoga therapy in schizophrenia patients.ConclusionsOur findings provide important insights into the mode of action of yoga therapy in schizophrenia. This study for the first time reports the epigenetic effects of yoga therapy on immune-inflammatory pathway in schizophrenia.Disclosure of InterestNone Declared

Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial.

There are few widely-available, evidence-based options to support quality of life (QOL) for people living with Alzheimer's disease and related dementias. We performed a randomized, controlled trial with a Waitlist control group to determine whether an online, livestream, mind-body, group movement program (Moving Together, 1 hour, 2 days/week, 12 weeks) improves QOL in people with cognitive impairment (PWCI) or care partners (CPs) and explore mechanisms of action. The primary outcome for both participants was self-reported QOL. Secondary outcomes and potential mediators included mobility, isolation, well-being, cognitive function, and sleep in PWCI and burden, positive emotions, caregiver self-efficacy, stress management, and sleep in CPs. Blinded assessors collected outcome data at baseline, 12, and 24 weeks. We assessed adverse events including falls through monthly check-in surveys and collected qualitative data through evaluation surveys. Intention-to-treat analyses used linear mixed models to compare mean change over time between groups and calculated standardized effect sizes (ESs). Ninety-seven dyads enrolled (PWCI: age 76 ± 11 years, 43% female, 80% non-Hispanic White; CPs: age 66 ± 12 years, 78% female, 71% non-Hispanic White); 15% withdrew before 12 weeks and 22% before 24 weeks. PWCI self-reported significantly better QOL from baseline to 12 weeks in the Moving Together group compared to the Waitlist group (ES = 0.474, p = 0.048) and CPs self-reported improved ability to manage stress (ES = 0.484, p = 0.021). Improvements in participant self-reported QOL were mediated by improvements in their self-reported well-being and CP-reported ability to manage stress. Results were similar when the Waitlist group participated in the program (QOL ES = 0.663, p = 0.006; stress management ES = 0.742, p = 0.002) and were supported by qualitative data. Exploratory analyses suggested possible fall reduction in PWCI. There were no study-related serious adverse events. Online programs such as Moving Together offer a scalable strategy for supporting high QOL for PWCI and helping CPs manage stress. ClinicalTrials.gov NCT04621448. The approval of new medications that slow cognitive decline in people living with Alzheimer's disease and related disorders (ADRD) has raised hope and excitement. However, these medications do not appear to impact quality of life, which is often considered by patients and care partners to be the most important outcome.In this randomized clinical trial, we found that an evidence-based, online, livestream, mind-body, group movement program significantly and meaningfully improves self-rated quality of life in people with ADRD and helps care partners manage stress. Mediation analyses revealed that the key drivers of improvements in participants' quality of life were improvements in their feelings of well-being and care partners' ability to manage stress. Exploratory analyses also suggested a 30% reduction in falls.These results are important because they suggest that an online program, which is available now and can be performed by people from the comfort of home or other location of choice, could be recommended as a complement or alternative to new therapies to help maximize quality of life for people living with ADRD and their care partners.

Effects of a Standardized Patient-Based Delirium Care Education Program.

Background and Purpose: An education program to improve the delirium care competency of nurses is important as they play an integral role in caring for patients with delirium. This study aimed to examine the effects of a standardized patient (SP)-based delirium care education program on new graduate nurses' performance and self-confidence. Methods: A waitlist control group with a crossover design was adopted. The SP-based delirium care education program was designed, implemented, and evaluated. Generalized estimating equations were used to analyze differences in performance and self-confidence scores between the intervention and waitlist control groups. Results: The education program was found to significantly affect rater-assessed performance, SP-assessed performance, and self-confidence when controlled for gender and age. Implications for Practice: An SP-based delirium care education program improved new graduate nurses' performance and self-confidence in caring for patients with delirium. Nurse educators should provide experiential learning opportunities to ensure that recent nurse graduates have achieved optimal delirium care competency.

Unleashing potential: Boosting physical activity in children with developmental disabilities via a family-dog-assisted intervention

Abstract In the context of a global crisis, where over 80% of children fail to meet minimum standards of physical activity, children with developmental disabilities may face an even greater health disparity. Despite being disproportionately less physically active than the broader population, those with developmental disabilities are often excluded from mainstream interventions. This study evaluated a novel animal-assisted intervention (AAI) that incorporated the family pet dog, with the goal of increasing physical activity in children with developmental disabilities. The intervention involved teaching child participants to engage in “Do as I Do” (DAID) reciprocal-imitation training with their dog over ten 60-min sessions. After enrollment, 45 child-dog pairs of children and their family dogs were randomly assigned to either the experimental intervention (DAID) group, the active control group (dog walking control [DWC]), or the passive control group (waitlist control [WC]). Physical activity was measured using a 7-day ActiGraph accelerometer monitoring process, and data were analyzed for children who wore the accelerometer for a minimum of 4 days at both assessment time points (N = 14). Participation in the intervention (DAID) group was found to significantly increase moderate-to-vigorous physical activity (MVPA) by 1.2 min/h ( p = 0.0087; Cohen’s d = 1.7) and significantly reduce sedentary behavior by 4.03 min/h ( p = 0.027; d = 1.3), outperforming the waitlist control group. Our findings demonstrate the potential of this novel dog-assisted intervention to improve physical activity in this population, thereby contributing to a reduction in health disparities.

Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK

BackgroundA serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context.AimsTo conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable.MethodsFollowing consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11–19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8–10-week post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality-of-life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, and the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention.DiscussionThe findings will inform the design of a future definitive RCT of SPARX in the UK. If the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK’s health services if delivered en masse.Trial registrationISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

Application of the Transtheoretical Model to Physical Activity and Health-related Quality of Life Among Older People Living With Frailty in the Community: The Fitness and Nutrition Program for Seniors (FANS) Study Protocol

Background: When the COVID-19 pandemic is combined with frailty, not only are older people's types of activities and willingness to be active limited, but also issues and hidden concerns about health care arise. However, the effectiveness of health promotion strategies incorporating remote care technologies remains to be explored. Therefore, the purpose of this study was to develop a hybrid learning approach based on a fitness and nutrition program for seniors (FANS). Simultaneously, the FANS follows the Transtheoretical Model (TTM) as an overall framework to design blended learning in in-person and telecare modalities for older people living with frailty in the community.Methods: This study is a non-randomized, control-group, pretest–posttest design. A total of 84 older participants living with frailty will be assigned to two groups. The intervention group will receive the 6-month, 9-session FANS through hybrid learning, which includes in-person physical activity (PA) training, nutritional guidance led by a nurse, and group discussions. The official account of the FANS and the group chat will provide individuals with online home practice at the current TTM stage, session time and home practice reminders, video reviews, consultations, and tutoring for telecare. The waitlist control group will maintain regular health promotion activities. Three repeated assessments (one pre-test and two post-training tests conducted after 3 months and after 6 months) will be conducted. The primary outcome measures will include frailty status, PA, and health-related quality of life (HRQoL), and the secondary outcome measures will be health-related data. Statistical analysis will include the Chi-squared test, Independent Sample t-test, and Generalized Estimating Equation (GEE).Discussion: This study will provide evidence that the FANS for older people living with frailty will have more positive and beneficial outcomes than the traditional method. Simultaneously, we hope the FANS will help the older population living with frailty in the community to transform their health difficulties in the future.Trial Registration: NCT05242549. Registered 22 February 2022.

Using Restricted Interests in Cognitive Behavioral Therapy for Children With Autism Spectrum Disorder: Results From a Preliminary Randomized Controlled Trial.

Children with autism spectrum disorder (ASD) exhibit significant deficits in social communication and emotion regulation skills. While cognitive behavioral therapy (CBT) applications appear promising, trials to date have largely excluded social communication skill development and have not been designed to include a wider range of emotional challenges. To our knowledge, the present study is the first to pilot a uniquely modified CBT program targeting emotion regulation, including social communication training, and explicitly focusing on the child's areas of circumscribed interest in order to teach skills and promote generalization. Forty participants were randomly assigned to either the CBT group or a waitlist control (WLC) group, resulting in 20 school-aged children in each group. The treatment approach was determined to be feasible and acceptable, and therapy engagement and attendance were reasonably high. Caregivers expressed high satisfaction with the program, qualitatively citing gains in skills such as social problem-solving, emotion identification, and identifying and processing cognitive distortions. The primary outcome of postintervention changes was not significantly different between the groups (CBT vs. WLC). The mean Social Skills Improvement System score decreased by 0.44 points (95% confidence interval [CI]: -5.04, 4.15) in the CBT group and increased by 0.41 points (95% CI: -4.23, 5.04) in the WLC group, and the postintervention changes were not significantly different between the groups (difference: -0.85; 95% CI: -7.29, 5.60; p = .79). The estimated rate of emotional dysregulation episodes decreased by a factor of 0.94 (95% CI: 0.57, 1.56) in the CBT group and increased by a factor of 1.07 (95% CI: 0.51, 2.24) for WLC (p = .74). Among those who reported emotional dysregulation episodes, the mean duration decreased by 1.39 minutes (95% CI: -3.90, 6.67) less for CBT than waitlist (p = .60). Although satisfaction, acceptability, and emotional dysregulation outcome results from this preliminary CBT treatment for ASD are promising, sample size and measurement limitations will be important considerations to inform future trials.