8-week Group Research Articles

Short-term effects of a park-based group mobility program on increasing outdoor walking in older adults with difficulty walking outdoors: the Getting Older Adults Outdoors (GO-OUT) randomized controlled trial

BackgroundWe estimated the short-term effects of an educational workshop and 10-week outdoor walk group (OWG) compared to the workshop and 10 weekly reminders (WR) on increasing outdoor walking (primary outcome) and walking capacity, health-promoting behavior, and successful aging defined by engagement in meaningful activities and well-being (secondary outcomes) in older adults with difficulty walking outdoors.MethodsIn a 4-site, parallel-group randomized controlled trial, two cohorts of community-living older adults (≥ 65 years) reporting difficulty walking outdoors participated. Following a 1-day workshop, participants were stratified and randomized to a 10-week OWG in parks or 10 telephone WR reinforcing workshop content. Masked evaluations occurred at 0, 3, and 5.5 months. We modeled minutes walked outdoors (derived from accelerometry and global positioning system data) using zero-inflated negative binomial regression with log link function, imputing for missing observations. We modeled non-imputed composite measures of walking capacity, health-promoting behavior, and successful aging using generalized linear models with general estimating equations based on a normal distribution and an unstructured correlation matrix. Analyses were adjusted for site, participation on own or with a partner, and cohort.ResultsWe randomized 190 people to the OWG (n = 98) and WR interventions (n = 92). At 0, 3, and 5.5 months, median outdoor walking minutes was 22.56, 13.04, and 0 in the OWG, and 24.00, 26.07, and 0 in the WR group, respectively. There was no difference between groups in change from baseline in minutes walked outdoors based on incidence rate ratio (IRR) and 95% confidence interval (CI) at 3 months (IRR = 0.74, 95% CI 0.47, 1.14) and 5.5 months (IRR = 0.77, 95% CI 0.44, 1.34). Greater 0 to 3-month change in walking capacity was observed in the OWG compared to the WR group (βz-scored difference = 0.14, 95% CI 0.02, 0.26) driven by significant improvement in walking self-efficacy; other comparisons were not significant.ConclusionsA group, park-based OWG was not superior to WR in increasing outdoor walking activity, health-promoting behavior or successful aging in older adults with difficulty walking outdoors; however, the OWG was superior to telephone WR in improving walking capacity through an increase in walking self-efficacy. Community implementation of the OWG is discussed.Trial registrationClinicalTrials.gov NCT03292510 Date of registration: September 25, 2017.

No difference between 5 and 6 weeks of non-weight bearing after osteochondral grafts for medial osteochondral defects of the talus with medial malleolar osteotomy.

The present study aimed to compare the clinical outcomes and safety at a 1-year follow-up after 5 or 6 weeks of non-weight bearing after a Talar OsteoPeriostic grafting from the Iliac Crest (TOPIC) for a medial osteochondral lesion of the talus (OLT). A retrospective comparative case-control analysis of prospectively followed patients who underwent a TOPIC procedure with medial malleolus osteotomy was performed. Patients were matched in two groups with either 5 or 6 weeks of non-weight bearing. Clinical outcomes were evaluated using the Numeric Rating Scale (NRS) during walking, rest, running, and stairclimbing. Additionally, the Foot and Ankle Outcome Score (FAOS) and American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score were assessed. Moreover, radiology and complications were assessed. Elevenpatients were included in the 5-week non-weight bearing group and 22 in the 6-week non-weight bearing group. No significant differences were found in any of the baseline variables. The NRS during walking in the 5-week group improved by 3.5 points and 4 points for the 6-week group (p = 0.58 at 1-year post-operatively). In addition, all other NRS scores, FAOS subscalesand the AOFAS scores improved (all n.s. at 1 year follow-up). No significant differences in radiological (osteotomy union and cyst presence in the graft) were found. Moreover, no significant differences were found in terms of complications and reoperations. No statistical significant differences were found in terms of clinical, radiologicaland safety outcomes between 5 or 6 weeks of non-weight bearing following a TOPIC for a medial OLT. Level III, Therapeutic.

A Randomized Trial Evaluating Acceptance and Commitment Therapy and Smart Phone Care Management Application to Augment Buprenorphine Therapy for Opioid Use and Chronic Pain.

There is high comorbidity of opioid use disorder (OUD) and chronic pain (CP), which is often addressed by prescribing buprenorphine (BUP). While BUP is effective in preventing overdose, it does not address the psychological aspects of OUD and CP comorbidity and treatment retention rates are as low as 50%. The Virtual Opioid use disorder Integrated Chronic Pain Treatment (VOICE) study (NCT05039554) is a novel effectiveness-implementation trial to test a 12-week virtual group Acceptance and Commitment Therapy (ACT) protocol and a care management smartphone application (app; Valera Health) on pain and opioid use in patients with OUD and CP receiving BUP. Using a 2 × 2 factorial design, participants (expected N = 280) are randomized into: ACT, Valera app, ACT + Valera, or Treatment as Usual arm. This study is taking place in the Bronx, NY, a racially/ethnically diverse community that faces numerous socioeconomic stressors and is one of the nation's epicenters of the opioid epidemic. We created a culturally responsive ACT group protocol, and Valera psychoeducational material. Outcome measures include NIH HEAL Common Data Elements and ACT and Valera-specific measures. We are conducting a novel 2 × 2 trial investigating augmenting BUP treatment with ACT and Valera, with the goal that improved mental health and access to care will result in decreased and opioid use and pain interference.

The Impact of Group Art Observation on Mentalization for Mothers of Children Diagnosed With ASD

This pilot study explored meaning of shared art observations and their impact on mentalization for five mothers of children with autism spectrum disorder, who participated in a 12-week art therapy group, post-intervention reflections on their experiences and art responses designed to assess the mentalization of self and their child before and after the group. The findings suggested that group art observation promoted belonging, facilitated emotional and cognitive learning, and increased comprehension of their child’s diagnosis. The study also demonstrated a visible shift in participants’ mentalization of self and others (perception of their child/relationship). Clinical implications include the distinctive benefits of a shared community gaze for this population, as a vehicle of self-knowing, which enables more effective communication with, about and for their child.

Safety Nets: A Social Prescribing Intervention to Support Young People on CAMHS Waiting Lists

High numbers of children face mental health difficulties in the UK, leading to increased referrals to Child and Adolescent Mental Health Services (CAMHS) which face reduced capacity and increased waiting times. Children’s mental health can deteriorate significantly during this wait for treatment. Safety Nets is an 8-week group intervention for children on CAMHS waiting lists, involving psychoeducation and physical activity co-delivered by clinicians and coaches at local sports clubs. A mixed-methods feasibility study was conducted exploring the impact of Safety Nets. A fully powered trial is now needed to further test for clinical and cost-effectiveness and to support future implementation.

Cultural adaptation of a trauma-informed mind-body intervention for survivors of human trafficking

In this Voices from Practice article, we present the process for adapting a 12-week mind-body group mental health intervention from development and implementation in Uganda for implementation with human trafficking survivors in the Philippines. We summarize key steps in the intervention adaptation process, outlining recommendations for other social work practitioners interested in culturally adapting community mental health interventions. This Voices from Practice piece provides guidance to social workers regarding an intentional and client-centered approach to adaptation of interventions across cultural contexts.

Long-Term Outcomes of Adjuvant Trastuzumab for 9 Weeks or 1 Year for ERBB2-Positive Breast Cancer

The standard adjuvant treatment for patients with ERRB2-positive breast cancer is chemotherapy plus 1 year of trastuzumab. Shorter durations of trastuzumab administration improve cardiac safety, but more information is needed about their effect on survival. To compare survival outcomes after 9-week vs 1-year administration of trastuzumab with the same adjuvant chemotherapy. This post hoc secondary analysis of an open-label, multicenter, noninferiority-design randomized clinical trial included women aged 18 years or older with early ERBB2-positive, axillary node-negative or axillary node-positive breast cancer who were enrolled from January 3, 2008, to December 16, 2014, at 65 centers in 7 European countries. The current exploratory analysis was conducted after achieving the maximum attainable follow-up data when the last patient enrolled had completed the last scheduled visit in December 2022. Chemotherapy consisted of 3 cycles of docetaxel administered at 3-week intervals followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide at 3-week intervals. Trastuzumab was administered in both groups for 9 weeks concomitantly with docetaxel. In the 9-week group, no further trastuzumab was administered after chemotherapy, whereas in the 1-year group, trastuzumab was continued after chemotherapy to complete 1 year of administration. The primary objective was disease-free survival (DFS). Distant DFS and OS were secondary objectives. Survival between groups was compared using the Kaplan-Meier method and log-rank test or univariable Cox proportional hazards regression. Among the 2174 women analyzed, median age was 56 years (IQR, 48-64 years). The median follow-up time was 8.1 years (IQR, 8.0-8.9 years); 357 DFS events and 176 deaths occurred. Trastuzumab for 9 weeks was associated with shorter DFS compared with trastuzumab for 1 year (hazard ratio [HR], 1.36; 90% CI, 1.14-1.62); 10-year DFS was 80.3% in the 1-year group vs 78.6% in the 9-week group. The 5-year and 10-year OS rates were comparable between the 9-week and 1-year groups (95.0% vs 95.9% and 89.1% vs 88.2%, respectively; HR for all time points, 1.20; 90% CI, 0.94-1.54). In multivariable analyses, 9-week treatment was associated with shorter DFS compared with 1-year treatment (HR for recurrence or death, 1.36; 95% CI, 1.10-1.68; P = .005), but there was no between-group difference in OS (HR, 1.22; 95% CI, 0.90-1.64; P = .20). Only 4 patients (0.2%) died of a cardiac cause. In this secondary analysis of a randomized clinical trial, 1-year vs 9-week adjuvant trastuzumab was associated with improved DFS among patients with ERRB2-positive breast cancer receiving chemotherapy, but there was no significant difference in OS between the groups. ClinicalTrials.gov Identifier: NCT00593697.

Assessment of blood viral load in asymptomatic and symptomatic cases of congenital cytomegalovirus infection.

This study aimed to retrospectively evaluate the baseline and follow-up viral loads and viral clearance times in cases followed for asymptomatic and symptomatic congenital cytomegalovirus (cCMV) infection between August 2010 and August 2022. Among 93 cases, they had asymptomatic (n: 55) and symptomatic (n: 38). The median baseline blood viral load detected in the symptomatic cCMV (ScCMV) infection (13 054 IU/mL) was significantly higher than that of asymptomatic cCMV (AcCMV) infection (4636 IU/mL) (p < 0.013). There was no difference in median viral clearance times (75 and 90 days, respectively) in baseline viremic cases in the ScCMV and AcCMV infection groups. There were no differences in median baseline blood viral load (6930 IU/mL and 14 268 IU/mL, respectively) and median viral clearance times (75 and 85 days, respectively) between the 6-week and 6-month antiviral treatment group. No correlation was found between baseline blood viral load, clinical severity, and the number of systems involved. However, in initial viremic cases, the viral load threshold for a symptomatic case was 8856 IU/mL, with 85.7% sensitivity and 54.5% specificity.

A novel multifamily treatment targeting symptoms related to Latinx caregiver deportation.

Latinx youth who have experienced caregiver deportation show higher rates of posttraumatic stress disorder (PTSD) and internalizing symptoms compared to Latinx youth who have not. Thus, there is a need for culturally and linguistically appropriate therapeutic approaches to address psychiatric needs related to caregiver deportation. Positive Adaptations for Trauma and Healing (PATH) is a manualized 10-week group therapy for Latinx youth and their caregivers that integrates trauma-informed interventions with positive psychology and resilience interventions. The present study examined PATH for reducing trauma symptomatology for Latinx youth who endured at least three traumatic experiences in their caregiving system as well as differences for Latinx youth who experienced their caregiver's deportation. Self-identified Latinx youth (N = 31) and their Spanish-speaking caregivers were recruited from two urban hospitals. All youth experienced three or more traumatic events. Pre- to postintervention mean change was measured with t tests; mixed-effects analysis of variance assessed whether the program was feasible for youth who had experienced a caregiver deportation versus Latinx youth who did not. Assessment with the Trauma Symptom Checklist and the UCLA PTSD Index for Youth showed statistically significant reductions on Anxiety, Depression, Anger, and PTSD subscales. Latinx youth who experienced a caregiver's deportation exhibited larger reductions in anger symptoms and PTSD symptoms. Study results suggest that the novel group therapy intervention was feasible and acceptable for Latinx youth and their caregivers. Despite a small sample size, the intervention proved feasible for Latinx youth who experienced caregiver deportation. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Predictors of Response to Cognitive Behavioral Therapy in Patients With Tinnitus

Clinical guidelines recommend cognitive behavioral therapy (CBT) as a treatment for tinnitus. However, patient response to CBT is variable, and currently, there are no known predictors of response to CBT treatment for tinnitus. To identify the clinical predictors of patient response to CBT for treatment of tinnitus. This was a secondary cohort analysis of a single-arm clinical study including adults with chronic bothersome tinnitus recruited from Washington University School of Medicine in St Louis (Missouri) from September 2019 to February 2023. Participants completed an 8-week group CBT program with a licensed clinical psychologist. Each week consisted of 2.5 hours of CBT, amounting to 20 hours of total CBT participation, primarily delivered through a virtual platform. Conjunctive consolidation was used to create a predictive classification system for response to CBT based on tinnitus bother and anxiety levels. Response to CBT was predefined as a 13-point or greater decrease in the Tinnitus Functional Index (TFI) survey score. The study sample included 88 adult patients (median [IQR] age, 59 [49-66] years; 47 [53%] females and 41 [47%] males) with chronic bothersome tinnitus, of whom 53 (60%) had at least 13-point decrease in TFI and were considered to be responders. In univariable and multivariable logistic regression analyses, high to moderate anxiety level and severe tinnitus bother were associated with treatment response (adjusted odds ratio: anxiety, 3.33; 95% CI, 0.90-12.30; tinnitus bother, 12.08; 95% CI, 1.48-98.35). The clinical stratification system showed good predictive and discriminative ability (χ2 for linear trend = 20.0; C statistic = 0.75; 95% CI, 0.65-0.85). The findings of this study show that assessment of bother and anxiety levels in patients with tinnitus may be useful for identifying those who are more likely to respond to CBT. Before incorporation into clinical practice, future research should externally validate this finding in a separate population.

Cardiac diastolic dysfunction by cigarette smoking is associated with mitochondrial integrity in the heart.

Cigarette smoking behaviors are harmful and cause one out of ten deaths due to cardiovascular disease. As population sizes grow and number of cigarette smokers increases, it is vital that we understand the mechanisms leading to heart failure in cigarette smokers. We have reported that metabolic regulation of a histone deacetylase, SIRT1, modulates cardiovascular and mitochondrial function under stress. Given this conclusion, we hypothesized that chronic cigarette smoking led to cardiovascular dysfunction via a reduction SIRT1. Mice were randomly organized into smoking or nonsmoking groups, and the smoking group received cigarette smoke exposure for 16 weeks. Following 16-week exposure, diastolic function of the heart was impaired in the smoking group as compared to sham, indicated by a significant increase in E/e'. The electrical function of the heart was also impaired in the smoking group compared to the sham group, indicated by increased PR interval and decreased QTc interval. This diastolic dysfunction was not accompanied by increased fibrosis in mouse hearts, although samples from human chronic smokers indicated increased fibrosis compared to their nonsmoker counterparts. As well as diastolic dysfunction, mitochondria from the 16-week smoking group showed significantly impaired function, evidenced by significant decreases in all parameters measured by the mitochondrial stress test. We further found biochemical evidence of a significantly decreased level of SIRT1 in left ventricles of both mouse and human smoking groups compared to nonsmoking counterparts. Data from this study indicate that decreased SIRT1 levels by cigarette smoking are associated with diastolic dysfunction caused by compromised mitochondrial integrity.

Group intervention for family members of people with borderline personality disorder based on Dialectical Behavior Therapy: Implementation of the Family Connections® program in France and Switzerland

BackgroundFamilies and significant others of people with borderline personality disorder (BPD) show increased levels of psychological distress. Family Connections®, a 12-week group intervention based on the principles of Dialectical Behavior Therapy, was designed to provide families with both information about the disorder and emotion regulation skills. It has been progressively implemented in French-speaking European countries.MethodsWe conducted an observational, multicenter study in France and Switzerland. In total, 149 participants of the Family Connections program were included among five centers. Burden, depression, coping, and emotion regulation were assessed before and after the intervention. ResultsOne-way repeated measures MANOVA showed that the burden, depressive symptoms, emotion regulation and coping all changed significantly after the intervention (p < 0.001, partial η2 = 0.297). T-tests showed that the burden significantly decreased after the intervention (p < 0.0001, d = -0.48), as did depressive symptoms (p < 0.0001, d = -0.36) and difficulties in emotion regulation (p < 0.0001, d =-0.32) whereas coping improved (p < 0.0001, d = 0.53). Two-way mixed ANOVA showed that burden reduction was stronger among female than male participants (p = 0.048, η2 = 0.027). Before the intervention, the burden was higher for female than male participants (p < 0.001). An initial linear regression showed the burden reduction to be associated with a decrease in the resignation of the participants (β = 0.19, p = 0.047). A second linear regression showed the burden reduction to be associated with the intensity of the relatives’ symptoms at baseline (β = 0.22, p = 0.008) and improvement of emotional clarity of the participants (β = 0.25, p = 0.006).ConclusionThis Dialectical Behavior Therapy-Based psychoeducational intervention is an appropriate way to support French-speaking European families of people with BPD.

Feasibility and Acceptability of Yoga for Adolescents with Juvenile Idiopathic Arthritis.

Yoga is effective for adults with arthritis but unstudied in adolescents with juvenile idiopathic arthritis (JIA). A pilot study assessed the feasibility and acceptability of an 8-week group yoga intervention for adolescents ages 14-18 with JIA. Each 75-min session included breathing techniques, relaxation, mindfulness, and modified yoga postures, using yoga props and a rope wall. An online video was available for home practice. The outcome measures administered at the baseline and at 8 weeks were physician global assessment with joint count, visual assessment with a joint damage assessment index, the Pediatric Quality of Life Arthritis Module 3.0 (Peds QL), and the visual analog scale for pain. Thirteen out of 25 participants attended ≥1 class with a mean of 5.7 ± 2.2 classes. Common reasons for non-enrollment included distance, schedule, and lack of interest. The average distance to classes was 29.0 ± 41.7 miles. There was a trend toward improvement for joint count (p = 0.07), global assessment (p = 0.10), and the Pain and Hurt domain of the Peds QL (p = 0.13), but no other outcomes approached significance. Satisfaction data from an anonymous survey (n = 8) were high in all areas. Adolescents with JIA who attended yoga reported enjoyment, pain reduction, and interest in continued practice with no adverse events. Future studies should consider stakeholder engagement to reduce barriers and larger sample sizes to test the effectiveness.

Psychoeducation for Pathologic Narcissism and Narcissistic Personality Disorder: A Review and Proposal for a Good Psychiatric Management-based Six-week Group Program.

Pathologic narcissism (PN) and narcissistic personality disorder (NPD) are 2 common and stigmatized clinical constructs that are known to have large consequences for patients' functioning and mental health-related outcomes. To date, no treatment for these conditions has been empirically validated, but there is a relative consensus about the importance of psychoeducation. Here we present a model for a psychoeducational intervention for patients with PN or NPD. We start with a review of the current evidence on the role of psychoeducation in different treatment models for PN, and we discuss several aspects regarding the content and format of this type of intervention. Based on this review, we outline a 6-week Good Psychiatric Management-based psychoeducation group program that we developed. We also describe how such a psychoeducational intervention can be implemented individually, with fewer resources, in general care settings. Finally, we discuss the strengths and limitations of our approach and elaborate on the rationale for our proposal. We believe that this program proposal is a first step in the development of psychoeducational programs for PN and NPD that can be further corrected and enhanced.

Augmenting Virtual Mindfulness Group With a Mindfulness App in Integrated Primary Care: Development, Feasibility, and Acceptability

As the body of support for the usefulness of mindfulness-based practices within therapeutic intervention has grown, so has demand. To increase access to this evidence-based care, skill-building groups as well as mobile apps that deliver mindfulness training have been developed. However, evaluations of app-augmented group mindfulness interventions are lacking. This pilot study developed and implemented a protocol augmenting a virtual Veterans Affairs–Compassionate Awareness Learning Module (VA-CALM) group with the Mindfulness Coach app in a Mid-Atlantic VA health system. The 6-week app-augmented group was implemented across four cycles (n = 18) within the system’s Integrated Primary Care setting. Qualitative feedback was collected and used to improve the integrative protocol iteratively across group cycles. Feedback indicated participants found the app supported skill growth and that the group context enhanced app engagement, while others found it difficult to navigate the app and build new habits. Quantitative outcomes indicated improvements in stress, health-related quality of life, and the mindfulness skill of nonreactivity. App usage among group members ranged from none to frequent. Groups in combination with apps may be a feasible and acceptable way to support mindfulness skill growth and application to daily life for some veterans. Further study should focus on patient-level factors that are relevant to engagement and efficacy of app-augmented protocols, as well as whether engagement predicts clinical improvement.

ACTing Spiritually: Integrating Spiritual Care and Mental Health Care withina US Department of Veterans Affairs Inpatient Psychiatric Unit.

As a part of the VA's interprofessional fellowship in psychosocial rehabilitation, the authors developed an 8-week spirituality group manual, ACTing Spiritually, which incorporates principles of acceptance and commitment therapy (ACT) into a spirituality group protocol. The group, administered weekly as possible for 28weeks on an inpatient psychiatric unit at a veterans affairs (VA) medical center in West Haven, CT, aimed to incorporate veterans' spirituality into their mental health treatment through concepts of acceptance, values, mindfulness, and committed action. ACTing Spiritually ran in tandem with a basic ACT group and the two groups had comparable average group sizes, suggesting interest in ACTing Spiritually similarly compares to interest in a basic ACT group in this context. In addition, development of the group yielded several qualitative findings, including a discussion of the similarities and differences between ACT and spiritual care, clinical gains for chaplains conducting the group, and clinical tensions that arose through the process of integration. The study provided preliminary evidence of the potential feasibility and acceptability of ACTing Spiritually. Next steps should include a formal evaluation of its potential efficacy.

Randomized effectiveness-implementation trial of dialectical behavior therapy interventions for young people with borderline personality disorder symptoms.

Dialectical behavior therapy (DBT) is an evidence-based treatment for people with emerging borderline personality disorder (BPD). In "real world" clinical settings, standard DBT is resource intensive. Emerging evidence suggests that group-based DBT skills training alone can lead to promising outcomes. This hybrid type 1 effectiveness-implementation trial directly compared the effectiveness of an 8-week group DBT-skills training program and a 16-week DBT-informed program including individual treatment and group-based skills training. This pragmatic trial employed a staggered, parallel-groups design. We recruited 104 participants, aged 16-25 years, with emotion dysregulation or emerging BPD symptoms. Participants were randomized to receive either program at a youth mental health service located in the Gold Coast, Australia. Data was collected via online surveys at baseline, 8-week, 16-week, and 24-week follow-up. Mixed effect linear models compared groups on the primary outcomes of emotion dysregulation and BPD symptoms, and secondary outcomes of suicidal ideation, coping skills, depression, anxiety, and stress. Across groups there were significant and sustained improvements relating to emotion dysregulation, BPD symptoms, stress, depression, and emotion-focused coping; but not suicide risk, anxiety, or task-focused coping. There was no significant time by group differences between the 8-week and 16-week interventions on any primary or secondary outcome. The more intensive mode of delivering DBT was not more effective than the brief group-based skills training. Both interventions resulted in significant improvements across both primary and most secondary outcomes. These results have implications for clinical practice regarding length and intensity of DBT treatment in young people.

Immunogenicity and safety of beta variant COVID-19 vaccine AZD2816 and AZD1222 (ChAdOx1 nCoV-19) as primary-series vaccination for previously unvaccinated adults in Brazil, South Africa, Poland, and the UK: a randomised, partly double-blinded, phase 2/3 non-inferiority immunobridging study

AZD2816 is a variant-adapted COVID-19 vaccine that expresses the full-length SARS-CoV-2 beta variant spike protein but is otherwise similar to AZD1222 (ChAdOx1 nCoV-19). This study aimed to evaluate the safety and immunogenicity of AZD1222 or AZD2816 (or both) primary-series vaccination in a cohort of adult participants who were previously unvaccinated. In this phase 2/3, randomised, multinational, active-controlled, non-inferiority, immunobridging study, adult participants previously unvaccinated for COVID-19 were enrolled at 16 study sites in Brazil, South Africa, Poland, and the UK. Participants were stratified by age, sex, and comorbidity and randomly assigned 5:5:5:2 to receive a primary series of AZD1222 (AZD1222 group), AZD2816 (AZD2816 [4-week] group), or AZD1222-AZD2816 (AZD1222-AZD2816 group) at 4-week dosing intervals, or AZD2816 at a 12-week interval (AZD2816 [12-week] group) and evaluated for safety and immunogenicity through 180 days after dose 2. Primary outcomes were safety (rates of solicited adverse events occurring during 7 days and unsolicited adverse events occurring during 28 days after each dose) and immunogenicity (non-inferiority of pseudovirus neutralising antibody geometric mean titre [GMT], GMT ratio margin of 0·67, and seroresponse rate, rate difference margin of -10%, recorded 28 days after dose 2 with AZD2816 [4-week interval] against beta vs AZD1222 against ancestral SARS-CoV-2) in participants who were seronegative at baseline. This trial is registered with ClinicalTrials.gov, NCT04973449, and is completed. Between July 7 and Nov 12, 2021, 1449 participants were assigned to the AZD1222 group (n=413), the AZD2816 (4-week) group (n=415), the AZD1222-AZD2816 group (n=412), and the AZD2816 (12-week) group (n=209). Ten (2·6%) of 378 participants who were seronegative at baseline in the AZD1222 group, nine (2·4%) of 379 in the AZD2816 (4-week) group, eight (2·1%) of 380 in the AZD1222-AZD2816 group, and 11 (5·8%) of 191 in the AZD2816 (12-week) group had vaccine-related unsolicited adverse events. Serious adverse events were recorded in one (0·3%) participant in the AZD1222 group, one (0·3%) in the AZD2816 (4-week) group, two (0·5%) in the AZD1222-AZD2816 group, and none in the AZD2816 (12-week) group. Co-primary immunogenicity endpoints were met: neutralising antibody GMT (ratio 1·19 [95% CI 1·08-1·32]; lower bound greater than 0·67) and seroresponse rate (difference 1·7% [-3·1 to 6·5]; lower bound greater than -10%) at 28days after dose 2 were non-inferior in the AZD2816 (4-week) group against beta versus in the AZD1222 group against ancestral SARS-CoV-2. Seroresponse rates were highest with AZD2816 against beta (12-week interval 94·3% [95% CI 89·4-97·3]; 4-week interval 85·7% [81·5-89·2]) and with AZD1222 (84·6% [80·3-88·2]) against ancestral SARS-CoV-2. Primary series of AZD1222 and AZD2816 were well tolerated, with no emergent safety concerns. Both vaccines elicited robust immunogenicity against beta and ancestral SARS-CoV-2 with greater responses demonstrated when testing against SARS-CoV-2 strains that matched those targeted by the respective vaccine. These findings demonstrate the continued importance of ancestral COVID-19 vaccines in protecting against severe COVID-19 and highlight the feasibility of using the ChAdOx1 platform to develop COVID-19 vaccines against future SARS-CoV-2 variants. AstraZeneca.

The effect of green mussel (Perna viridis) shells’ hydroxyapatite application on alkaline phosphatase levels in rabbit femur bone defect

Background Non-union fractures can be prevented with bone grafts, such as hydroxyapatite made from green mussel shells. Green mussel shells contain a high percentage of HA, making them a promising alternative for bone healing. This research aims to reveal the effectiveness of green mussel shell HA as a bone substitute material and to provide knowledge for further research. Methods This research was conducted for four months using a true experimental research method with a post-test-only control group design. This study used 36 New Zealand rabbits (Oryctolagus cuniculus) which were divided into 9 groups: positive control, negative control, and intervention at weeks 2, 4 and 6 after the intervention. All groups were subjected to three general procedures: pre-surgery, surgery, and post-surgery. This study utilized histological evaluation and biochemical assessment, specifically measuring serum alkaline phosphatase (ALP) levels, to investigate the effects of hydroxyapatite (HA) from green mussel shells on bone healing in rabbits. Results The findings demonstrated that green mussel shell HA hashad efficacy in accelerating bone healing, better than HA bovine HA i.e. green mussel shell hydroxyapatite showed superior efficacy compared to bovine hydroxyapatite in accelerating and maximizing fracture healing, as compared to the 6-week negative control group and demonstrated a significant difference (p &lt; 0.05). Conclusions Green mussel hydroxyapatite is proven to be able to fasten and maximize the bone healing process as fast as bovine HA, and even has higher efficacy than bovine HA.

Connected through movement: a feasibility study of online mindfulness-based dance/movement therapy for older adults with age-related cognitive decline during COVID-19

Objectives Social isolation and loneliness pose significant public health risks, especially among older adults experiencing age-related cognitive decline (ACD). This mixed methods feasibility study explored the potential of an online mindfulness-based dance/movement therapy (M-DMT) program to alleviate loneliness, enhance psychological well-being, and promote physical activity among older adults experiencing ACD during the COVID-19 pandemic. Method Sixteen participants engaged in a 12-week online group M-DMT program. Feasibility was assessed via enrollment and retention rates, attendance, adverse events, credibility/expectancy, participant perceptions, and satisfaction. Qualitative data were collected to capture participants’ perspectives on the intervention’s usefulness and perceived benefits. The intervention’s preliminary impact on loneliness, depression, positive affect, psychological well-being, and physical activity was also examined. Results The study met all feasibility criteria, with 65% reporting post-intervention improvement. Significant reductions in loneliness and depression, along with enhanced positive affect and psychological well-being, were observed. Though physical activity increased, statistical significance was not achieved. Qualitative feedback highlighted improved social connectedness, overall quality of life, body awareness, kinematic strategy, and satisfaction with the program. Conclusion Online M-DMT holds promise in addressing well-being and loneliness challenges in older adults experiencing ACD. Further research is necessary to validate and expand upon these promising findings.