Post-treatment Week Research Articles

CTIM-30. NT-I7, A LONG-ACTING INTERLEUKIN-7, PROMOTES ACTIVATION, CYTOTOXIC FUNCTION, AND SELECTIVE CLONOTYPE EXPANSION OF CD8+ T CELLS IN PATIENTS WITH HIGH GRADE GLIOMAS

Abstract Lymphopenia following chemoradiation for high grade gliomas (HGG) is common and is associated with decreased survival. NT-I7 (efineptakin alfa) is a long-acting analog of the lymphocyte pro-survival cytokine, interleukin-7. Our Phase I dose-escalation study of 19 patients with HGG demonstrated early elevations in CD4+ and CD8+ T cells in the first 4 weeks after administration of NT-I7. In this study, we explored the diversity and potential functionality of the NT-I7-expanded T cell population. A subset of 4 subjects with glioblastoma multiforme (GBM) treated at 720 µg/kg of NT-I7 during adjuvant temozolomide in our study (NCT03687957) underwent Cellular Indexing of Transcriptomes and Epitopes by Sequencing (CITE-seq) of peripheral blood. CITE-seq with TCR clonotype sequencing (10x Genomics 5’) permitted simultaneous tracking of the T cell phenotype at the protein level, individual T cell clones, and gene expression dynamics between 4 timepoints: pre-treatment, and post-treatment weeks 1, 2, and 13. Here, we report the results of differential expression analyses between timepoints and patient-specific differences in T cell clonotype expansions. Both CD4+ and CD8+ T cells in our study patients had increased expression of T cell activation markers LTB, CISH, and CD74. CD8+ T cell subsets demonstrated additional elevations in genes important in cytotoxic function (granzymes (GZMA, GZMB) and perforin (PRF1)), MHC Class II expression (HLA-DRA, HLA-DRB1), and AP-1 transcription factor subunits (JUND, JUN, JUNB, FOS, FOSB). After excluding known viral antigen clonotypes, 2 of 4 patients demonstrated TCR clonotype expansion. Notably, nearly all the expanded TCR clonotypes were found within CD8+ T cells, but not CD4+ T cells. NT-I7 promotes activation, cytotoxic function, and selective clonotype expansion of CD8+ T cells in patients with HGG. This, combined with its role in increased CD4+ T cell counts, suggests NT-I7 may be a powerful tool to restore immune function after treatment-associated lymphopenia in HGG.

Scalable Technology for Adolescents and Youth to Reduce Stress in the Treatment of Common Mental Disorders in Jordan: Protocol for a Randomized Controlled Trial.

Young people in low- and middle-income countries encounter significant barriers to accessing mental health support due to various factors, including a substantial treatment gap and limited health care budgets allocated to mental health. Using innovative strategies, such as scalable digital self-help psychological interventions, offers a potential solution for improving access to mental health support. However, digital mental health interventions come with their own set of challenges, including issues related to low user engagement. Chatbots, with their interactive and engaging nature, may present a promising avenue for the delivery of these interventions. This study aims to explore the effectiveness of a newly developed World Health Organization (WHO) digital mental health intervention, titled Scalable Technology for Adolescents and Youth to Reduce Stress (STARS). A single-blind, 2-arm randomized controlled trial will be conducted nationally across Jordan. Participants will include 344 young adults, aged 18-21 years, currently residing in Jordan. Inclusion criteria are heightened levels of psychological distress as determined through the 10-item Kessler Psychological Distress Scale (≥20). Assessment measures will be conducted at baseline, 1-week post intervention, and 3-month follow-up. Following baseline assessments, eligible participants will be randomized to receive STARS or enhanced usual care. The primary outcomes are the reduction of symptoms of depression and anxiety (Hopkins Symptom Checklist, 25 subscales) at 3-month follow-up. Secondary outcomes include general functioning (WHO Disability Assessment Schedule 2.0), well-being (WHO-5 Well-Being Index), personal problems (Psychological Outcomes Profile), and agency (State Hope Scale subscale). The study was funded in January 2020 by the Research for Health in Humanitarian Crises Programme (Elhra) and recruitment for the trial started on July 16, 2023. As of November 15, 2023, we randomized 228 participants. This trial intends to contribute to the growing digital mental health evidence base by exploring technological solutions to address global public health challenges. Given the widespread use of technology globally, even in resource-constrained settings, and the high adoption rates among adolescents and young individuals, digital initiatives such as STARS present promising opportunities for the future of mental health care in low- and middle-income countries. ISRCTN Registry ISRCTN10152961; https://www.isrctn.com/ISRCTN10152961. DERR1-10.2196/54585.

Examining the associations between posttraumatic stress disorder symptom clusters across cognitive processing therapy.

Cognitive processing therapy (CPT) is a well-known trauma-focused treatment that aims to generate more adaptive posttrauma cognitions and emotions. Changes in cognitions are theorized to be the mechanism by which CPT leads to improvement in posttraumatic stress disorder (PTSD) symptoms. The present study aimed to explore associations between changes in PTSD symptom clusters during CPT. We hypothesized that early changes in negative alterations in cognitions and mood (NACM) would correlate with later changes in other symptom clusters. Data were collected from 296 veterans participating a 7-week PTSD residential treatment program at a U.S. Veterans Affairs medical center. PTSD symptoms were assessed at pretreatment (Week 1), midtreatment (Week 4), and posttreatment (Week 7). Cross-lagged path analyses demonstrated that pretreatment-to-midtreatment improvement in NACM was correlated with midtreatment-to-posttreatment improvement in avoidance, β =.52, though this association was bidirectional, suggesting pretreatment-to-midtreatment improvements in either cluster may be correlated with midtreatment-to-posttreatment improvements. Similarly, pretreatment-to-midtreatment improvement in intrusions, β =.40, and arousal, β =.49, were correlated with later improvement in avoidance, suggesting avoidance may improve after improvement in other clusters. Interestingly, pretreatment-to-midtreatment arousal improvement was significantly correlated with midtreatment-to-posttreatment NACM improvement, β =.27, though the reverse was nonsignificant, whereas a bidirectional association between arousal and intrusions emerged, β =.34, β =.53. Early changes in arousal were correlated with later changes in several other symptom clusters, whereas other clusters demonstrated bidirectional associations. These results may inform understanding of symptom improvement timing across CPT, which may aid in treatment selection and planning.

Study on the Mechanism of Nd:YAG Laser-Assisted Therapy on the Changes of Subgingival Flora in Periodontitis.

This study evaluated the therapeutic efficacy of combining Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser with subgingival curettage and root planing (SRP) in generalised stage III/grade C periodontitis patients and its effects on cytokine dynamics and microbial community. Fifteen patients diagnosed with stage III/grade C periodontitis were included in the cohort. The right and left sides of the mouth were randomly assigned either the conventional SRP (control) group or the SRP supplemented with Nd:YAG laser group (experimental group, 160 mJ, 4 W) in a split-mouth design. Clinical periodontal indices were recorded at baseline and at the 6-week follow-up post-treatment. ELISA was utilised to measure IL-1β and TNF-α levels in gingival crevicular fluid. The subgingival microbiota's composition and variations were characterised using 16S rDNA amplicon sequencing, while quantitative real-time polymerase chain reaction (qRT-PCR) was employed to analyse the changes in the red-complex bacteria in subgingival plaque. The SRP+Nd group exhibited a statistically significant reduction in record probing depth (PD) and bleeding on probing (BOP) compared to the SRP group after treatment (p0.05). The SRP+Nd group showed a markedly lower IL-1β level than the SRP group (p0.05). Furthermore, there was no statistically significant difference in the dominant subgingival microbiota composition and level of the red-complex bacteria between the two groups (p>0.05). The adjunctive use of Nd:YAG laser with SRP demonstrates promising short-term therapeutic benefits for patients with extensive stage III/grade C periodontitis. Both SRP as a standalone treatment and its combination with Nd:YAG laser effectively facilitate a transition in the dominant bacterial community from periodontitis-associated to periodontal health-associated microbiota.

Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study.

Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences arise from this psychiatric condition. Prompt treatment with an appropriate method of delivery is required to achieve optimal outcomes in GD patients. This protocol paper outlines a study to determine the effectiveness, acceptability, and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD in Indonesia. This non-randomized pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post- treatment completion (week 10), and 6 weeks post-treatment (week 16). The outcomes measured will be the change in gambling symptoms, gambling urges, cognitive distortions, readiness to change, emotional problems, and quality of life of the participants. The feasibility of iCBT for GD patients in Indonesia will be assessed by this study. The study's results will give an indication of the acceptability of the intervention and the feasibility of a subsequent conclusive trial. The delivery of iCBT may help to address the issue of treatment access in an extensive geographical region and provide immediate implications as a treatment resource for GD in practice.

Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial

BackgroundImmigrant Latinas (who are foreign-born but now reside in the USA) are at greater risk for developing postpartum depression than the general perinatal population, but many face barriers to treatment. To address these barriers, we adapted the Mothers and Babies Course—an evidence-based intervention for postpartum depression prevention—to a virtual group format. Additional adaptations are inclusion of tailored supplemental child health content and nutrition benefit assistance. We are partnering with Early Learning Centers (ELC) across the state of Maryland to deliver and test the adapted intervention.MethodsThe design is a Hybrid Type I Effectiveness-Implementation Trial. A total of 300 participants will be individually randomized to immediate (N = 150) versus delayed (N = 150) receipt of the intervention, Mothers and Babies Virtual Group (MB-VG). The intervention will be delivered by trained Early Learning Center staff. The primary outcomes are depressive symptoms (measured via the Center for Epidemiologic Studies-Depression Scale), parenting self-efficacy (measured via the Parental Cognition and Conduct Towards the Infant Scale (PACOTIS) Parenting Self-Efficacy subscale), and parenting responsiveness (measured via the Maternal Infant Responsiveness Instrument) at 1-week, 3-month, and 6-month post-intervention. Depressive episodes (Structured Clinical Interview for DSM-V- Disorders Research Version) at 3-month and 6-month post-intervention will also be assessed. Secondary outcomes include social support, mood management, anxiety symptoms, perceived stress, food insecurity, and mental health stigma at 1-week, 3-month, and 6-month post-intervention. Exploratory child outcomes are dysregulation and school readiness at 6-month post-intervention. Intervention fidelity, feasibility, acceptability, and appropriateness will also be assessed guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.DiscussionThis study will be one of the first to test the efficacy of a group-based virtual perinatal depression intervention with Latina immigrants, for whom stark disparities exist in access to health services. The hybrid effectiveness-implementation design will allow rigorous examination of barriers and facilitators to delivery of the intervention package (including supplemental components) which will provide important information on factors influencing intervention effectiveness and the scalability of intervention components in Early Learning Centers and other child-serving settings.Registration.ClinicalTrials.gov NCT05873569.

Assessing physical fitness adaptations in collegiate male soccer players through training load parameters: a two-arm randomized study on combined small-sided games and running-based high-intensity interval training.

To evaluate the effects of a 4-week intervention combining small-sided games (SSGs) and high-intensity interval training (HIIT) on physical fitness in collegiate male soccer players. Twenty-one soccer players were randomly assigned to either the HIIT + SSGs group (n = 11) or a control group (n = 10). Physical fitness was assessed at baseline and 1-week post-intervention, including countermovement jump (CMJ), change of direction (COD) test, sprint test, repeated sprint ability (RSA) test, and 30-15 Intermittent Fitness Test (30-15IFT). The intervention comprised eight sessions over 4weeks: four SSGs and four HIIT. The intervention group showed small to moderate improvements: mean RSA improved by 4.5% (p = 0.07), CMJ increased by 3.2% (p = 0.12), and 30-15IFT scores enhanced by 6.8% (p = 0.09). Key predictors of group membership included heart rate load per minute (OR 1.602) and various GPS variables. The 4-week intervention combining SSGs with HIIT did not produce statistically significant improvements in most physical fitness variables compared to the control group. Although there were positive trends in variables such as RSA and 30-15IFT, these changes were modest and not statistically significant. The results suggest that while the combined SSGs and HIIT approach shows potential, its impact on physical fitness over a 4-week period is limited, with some variables, like CMJ, even showing decreases.

Efficacy and Safety of Valbenazine in Elderly and Nonelderly Japanese Patients With Tardive Dyskinesia: A Post Hoc Analysis of the J-KINECT Study.

The efficacy and safety of valbenazine, a selective vesicular monoamine transporter 2 inhibitor, has been confirmed for treatment of tardive dyskinesia (TD) in patients aged ≥65 years in non-Asian clinical trials; however, data are lacking in elderly Asian patients. This post hoc analysis of J-KINECT aimed to evaluate the efficacy and safety of valbenazine in elderly Japanese patients with TD. J-KINECT was a randomized, double-blind, placebo-controlled study with a 6-week double-blind, placebo-controlled period; 42-week double-blind, valbenazine extension period; and 4-week posttreatment observation period. Outcomes were summarized by age (≥65 years [elderly] and <65 [nonelderly]) and treatment group. The safety analysis set included 100 and 153 patients aged ≥65 and <65 years, respectively (intention-to-treat set: 98 and 151 patients, respectively). In the elderly group, the difference versus placebo in least-squares mean change from baseline in the Abnormal Involuntary Movement Scale total score at week 6 was -3.1 (95% confidence interval: -4.5, -1.7) and -5.5 (-7.0, -3.9) with valbenazine 40 and 80 mg, respectively; in the nonelderly group, respective differences were -1.5 (-2.6, -0.4) and -2.5 (-3.6, -1.3). Both age groups showed improvement in Clinical Global Impression of Change-Tardive Dyskinesia scores with valbenazine. The incidence of treatment-emergent adverse events (TEAEs) leading to treatment discontinuation was higher in the elderly versus nonelderly group. There was no trend toward higher incidences of TEAEs or related TEAEs in the elderly group. The findings suggest that valbenazine may be used effectively and safely as a treatment for TD, even in elderly patients.

RTMS for Poststroke Pusher Syndrome: A Randomized, Patient-Blinded Controlled Clinical Trial

Background Patients with poststroke pusher syndrome (PS) require longer duration of rehabilitation and more supplemental care after discharge. Effective treatment of PS remains a challenge. The role of repetitive transcranial magnetic stimulation (rTMS) for PS has not been examined. Objective Assess the efficacy of rTMS for patients with poststroke PS in reducing pushing behavior, enhancing motor recovery and improving mobility. Methods A randomized, patient- and assessor-blinded sham-controlled trial with intention-to-treat analysis was conducted. Thirty-four eligible patients with poststroke PS were randomly allocated to receive either rTMS or sham rTMS for 2 weeks. Pushing behavior on the Burke lateropulsion scale and scale for contraversive pushing, motor function on Fugl-Meyer assessment scale-motor domain (FMA-m) and mobility on modified Rivermead mobility index were measured at baseline, 1 and 2 weeks after intervention. Repeated-measures analysis of covariance was used for data analysis. Results There was no significant interaction between intervention and time on Burke lateropulsion scale (F = 2.747, P = .076), scale for contraversive pushing (F = 1.583, P = .214), or change of modified Rivermead mobility index (F = 1.183, P = .297). However, a significant interaction between intervention and time was observed for FMA-m (F = 5.464, P = .019). Post hoc comparisons of FMA-m show better improvement in rTMS group with mean differences of 12.7 (95% CI −7.3 to 32.7) and 15.7 (95% CI −4.6 to 36.0) at post-treatment week 1 and week 2 respectively. Conclusions rTMS did not demonstrate significant efficacy in improving pushing behavior and mobility in patients with PS. However, rTMS might have potential effect in enhancing motor function for patients with PS. Registration: The study was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR2200058015 at http://www.chictr.org.cn/searchprojen.aspx) on March 26, 2022.

Easing Panic: The Effect of an Online Psychoeducational Program on Panic Symptoms, Anxiety, and Quality of Life Among People Experiencing Panic Attacks

Panic attacks (PAs) are intense episodes of anxiety with severe physical symptoms that can impair an individual’s social and occupational functions. Psychoeducation, a structured educational intervention, aims to improve various health aspects, including mental disorders. Delivering psychoeducation via the Internet can overcome barriers to accessing mental health treatment. This study examined the effectiveness of online psychoeducation on panic symptoms, anxiety, and quality of life (QOL) among people experiencing PAs. In this quasi-experimental design, 157 participants with PAs were recruited, and 136 eligible participants were allocated to treatment and control groups. The treatment group received an eight-session online psychoeducational program over 8 weeks, while the control group received reading materials. Outcome variables, including panic symptoms, anxiety, and QOL, were measured at baseline, 1-week post-intervention, and at 8-week follow-up using the Panic Disorder Dimensional (PD-D) scale, the Generalized Anxiety Disorder (GAD-7) scale, and the World Health Organization Quality of Life-BREF (WHOQOL-BREF), respectively. In the treatment group, the split-plot ANOVA showed a significant reduction in panic symptoms [F(1, 98) = 18.86, p < 0.01] and anxiety [F(1, 98) = 18.241, p < 0.01] compared to the control group. However, the intervention did not significantly affect QOL [F(1, 98) = 0.278, MSE = 153.007, p > 0.05]. The online psychoeducational program effectively reduced panic symptoms and anxiety levels but did not significantly impact QOL. Internet-based interventions, including psychoeducation, can improve access to mental health treatment, potentially reducing the treatment gap and enhancing overall mental health outcomes.

Translated and culturally adapted internet-delivered cognitive therapy for social anxiety disorder in Japanese clinical settings: study protocol for a randomised controlled trial

BackgroundCognitive therapy for social anxiety disorder (CT-SAD) has extensive empirical support and is recommended in several national guidelines. However, ensuring access to evidence-based psychological therapies such as CT-SAD remains a global challenge. An internet-delivered version of this treatment protocol (iCT-SAD) has recently been developed in the UK as a way to overcome this challenge, demonstrating comparable outcomes to face-to-face CT-SAD whilst requiring less therapist time per client. Initial findings also suggest its cross-cultural transferability, but the previous studies in other cultural settings used the English language programme and only included English-fluent participants as a second language. It is not yet known what outcomes can be achieved once the programme has been translated and adapted for a different cultural context. Therefore, this trial aims to evaluate the clinical efficacy of Japanese iCT-SAD when combined with treatment as usual (TAU) in clients with SAD.MethodsThis two-arm, parallel-group, superiority randomised controlled trial will recruit 60 Japanese participants with SAD, randomly assigning them to either Japanese iCT-SAD + TAU or TAU alone at a ratio of 1:1. The primary outcome measure is the self-report Liebowitz Social Anxiety Scale, and secondary.outcomes include other measures of social anxiety symptoms and processes, general mood and functioning, and response to treatment. We will also assess treatment acceptability and gather participant feedback. Assessments will take place at baseline (week 0), mid-treatment (week 8), and post-treatment (week 15), with a further 3-month follow-up (week 27) for the iCT-SAD + TAU arm. The primary analyses will be conducted on an intent-to-treat basis, comparing the primary and secondary outcome measures between groups using linear mixed-effect models, along with additional mediation analysis.DiscussionInvestigating the efficacy of translated and culturally adapted iCT-SAD in different cultural contexts is an important step in evaluating the global reach of internet interventions. This trial will provide valuable insights into the effects of iCT-SAD combined with usual care, and how this treatment could be delivered in routine clinical settings in Japan.Trial registrationInternational Standard Randomized Controlled Trials (ISRCTN), ISRCTN82859645, registered on January 19, 2024. UMIN Clinical Trials Registry (UMIN-CTR), UMIN000052702, registered on November 6, 2023.

Repetitive transcranial magnetic stimulation to treat chronic tinnitus: a feasibility study

ABSTRACT This study aimed to evaluate the feasibility, safety and preliminary efficacy of high-frequency repetitive transcranial magnetic stimulation for treating chronic subjective tinnitus. Eleven adults (8 males; age: 56.70 ± 11.42 years, tinnitus duration: 12.43 ± 7.43 years) were recruited to participate in a pre-registered study. Six treatments were provided over two weeks. Feasibility was determined against pre-specified criteria addressing recruitment, adherence (protocol, 2-week follow-up, 4-week follow-up), and perceived usefulness, helpfulness and acceptability. Adverse events were recorded and preliminary efficacy was assessed using the Tinnitus Handicap Inventory. Five out of seven feasibility criteria were met and no serious adverse events occurred. One participant withdrew from the study due to stimulation being uncomfortable. Preliminary efficacy data indicated a significant effect of Time on tinnitus (p < 0.001). Compared to baseline, tinnitus reduced at mid-treatment (t (9) = −3.47, p = 0.028) and 4-weeks post treatment (t (9) = −3.62, p = 0.024). A repetitive transcranial magnetic stimulation protocol to manage chronic subjective tinnitus appears feasible, safe, and may have preliminary evidence of effectiveness. The recommendation is to proceed to trial with minor adjustments to gain further insight into the patient experience.

Reducing intrusive suicidal mental images in patients with depressive symptoms through a dual-task add-on module: Results of a multicenter randomized clinical trial.

To examine the safety and efficacy of a brief cognitive dual-task (using eye movements) add-on module to treatment as usual (TAU) in reducing the severity and frequency of intrusive suicidal mental images and suicidal ideation. We conducted a single-blind, parallel multicenter randomized trial (No. NTR7563) among adult psychiatric outpatients (N = 91; Mage = 34.4, SD = 13.54; 68% female) with elevated depressive symptoms and experiencing distressing suicidal intrusions in the Netherlands. Primary outcome was the severity (Suicidal Intrusions Attributes Scale) and frequency (Clinical Interview for Suicidal Intrusions) of suicidal mental imagery intrusions at 1-week posttreatment and 3-month follow-up. Primary analysis was intention-to-treat. Between November 27, 2018 and September 13, 2021, 91 patients were included and randomly assigned to intervention group (Cognitive Dual Task Add-on + TAU) (n = 46) or TAU-only (n = 45). Cognitive Dual Task Add-on + TAU had greater reductions in severity (mean difference, -15.50, 95% CI [23.81, -7.19]; p < .001, d = 0.60), and frequency (geometric mean difference, 0.47, 95% CI [0.29, 0.79]; p = .004) of suicidal intrusions over time than TAU-alone. Cognitive Dual Task Add-on + TAU patients also showed lower suicidal ideation over time (p = .008, d = 0.42). There were no significant group differences in reductions in depressive symptoms, rumination, or hopelessness. Four serious adverse events occurred (three Cognitive Dual Task Add-on + TAU; one TAU-only); all unlikely attributable to intervention/trial. Findings provide support for the effectiveness of adding a cognitive dual-task module to the treatment of psychiatric outpatients with elevated depressive symptoms in reducing suicidal intrusions and ideation and can be executed safely. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Safety and Efficacy of Directly Acting Antivirals (Sofosbuvir &amp; Daclatasvir) in Treatment of Chronic HCV

Abstract Background The introduction of direct-acting antiviral agents, has revolutionized the treatment for chronic HCV with higher cure rates, shorter duration of treatment and more tolerability have been achieved. Aim of the Work The aim of our study is to estimate the efficacy and safety of DAAs in treatment of chronic HCV in patients co-infected with HIV. Patients and Methods This study of previously untreated HCV infection in patients with HCV and HIV co-infection conducted at Abbasia Fever Hospital, from July 2019 to February 2020. Patients included are chronic HCV infection and were receiving antiretroviral therapy for the HIV with a CD4 T-lymphocyte count of 200 cells/mL or greater. Serial measurements of safety parameters, virologic and host immune correlates, and adherence were performed during treatment by combination of daclatasvir 90mg and sofosbuvir 400mg+/- ribavirin 800mg daily for 12 weeks. Results In this study, the rate of a sustained virologic response (SVR) at post-treatment week 12 (SVR 12) were high (29/30, 96.67%). The most common adverse events were fatigue (73.33%), headache (46.67%), and there was a high safety profile on using DAAs. No patient discontinued treatment because of adverse events. No serious adverse events or mortality were reported. In this study, AST &amp; ALT were significantly decreased at end of treatment and 12 weeks after treatment, CD4 count was significantly increased. Otherwise there are no significant changes in both hematological and biochemical laboratory results. Conclusion Combination of daclatasvir and sofosbuvir have showed 96.67% sustained virologic response at 12 weeks after treatment (SVR 12) among HIV/HCV co-infected patients, with a very good safety profile. Moreover, the treated patients showed a significant increase in CD4 count. Accordingly, HIV/HCV co-infected patients should be treated with sofosbuvir and daclatesvir containing regimens.

An Online Mindfulness-Based Group Intervention for Tics: A Pilot Randomized Controlled Trial.

Current treatments for Tourette syndrome (TS) and persistent tic disorder (PTD) are often insufficiently effective, inaccessible, and frequently associated with adverse events. Thus, we must continue to develop and test effective, accessible, and safe treatment options. We aimed to conduct a pilot randomized controlled trial (RCT) comparing a novel, videoconference-delivered group mindfulness-based intervention for tics (MBIT) to videoconference-delivered group psychoeducation, relaxation, and supportive therapy (PRST) for adults with TS or PTD. Thirty-two adults with TS or PTD were randomly assigned to receive 8 weeks of either MBIT or PRST. Tic severity, tic-related impairment, and global improvement were assessed by a trained, independent evaluator who was masked to treatment condition at baseline (week 0), posttreatment (week 9), 1-month follow-up, and 6-month follow-up. All study procedures were conducted online via secure videoconferencing. Twenty-eight participants began treatment and were included in analyses. MBIT, relative to PRST, was associated with a significantly greater decline in tic severity (d = 0.85) and tic-related impairment (d = 0.99) from baseline to posttreatment. Treatment response was significantly higher in MBIT (69%) than in PRST (13%). Neither treatment resulted in serious adverse effects. The durability of treatment outcomes is also reported and discussed. The results from this pilot RCT suggest that videoconference-delivered group MBIT may be an efficacious, accessible, and safe intervention for adults with tics. Future research is necessary to confirm these preliminary findings. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans

Chronic pain is common and disabling in older adults, and psychological interventions are indicated. However, the gold standard approach, cognitive-behavioral therapy (CBT), produces only modest benefits, and more powerful options are needed. To evaluate whether emotional awareness and expression therapy (EAET) is superior to CBT for treatment of chronic pain among predominantly male older veterans and whether higher baseline depression, anxiety, or posttraumatic stress disorder (PTSD) symptoms-key targets of EAET-moderate treatment response. This 2-arm randomized clinical trial was conducted from May 16, 2019, to September 14, 2023, in the US Department of Veterans Affairs Greater Los Angeles Healthcare System. The trial included a racially and ethnically diverse group of veterans aged 60 to 95 years with at least 3 months of musculoskeletal pain. Emotional awareness and expression therapy or CBT, conducted concurrently, each presented as one 90-minute individual session followed by eight 90-minute group sessions. The primary outcome was Brief Pain Inventory pain severity (range, 0 to 10) from baseline to posttreatment (week 10, primary end point) and 6-month follow-up. Secondary outcomes included Patient Reported Outcomes Institute Measurement System Anxiety, Depression, Fatigue, General Life Satisfaction (NIH Toolbox), Pain Interference, and Sleep Disturbance Short Forms, Patient Global Impression of Change (PGIC), and Satisfaction with Therapy and Therapist Scale-Revised. A subset of participants completed the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). All analyses were for the intention-to-treat population and included all randomized participants. Among 126 randomized participants (66 in the EAET group and 60 in the CBT group; mean [SD] age, 71.9 [5.9] years; 116 [92%] male), 111 (88%) completed posttreatment, and 104 (82%) completed the 6-month follow-up. The EAET was superior to CBT for the primary outcome of reduction in pain severity at posttreatment (estimate, -1.59 [95% CI, -2.35 to -0.83]; P < .001) and follow-up (estimate, -1.01 [95% CI, -1.78 to -0.24]; P = .01). A greater percentage of participants in EAET vs CBT had clinically significant (at least 30%) pain reduction (63% vs 17%; odds ratio, 21.54 [95% CI, 4.66-99.56]; P < .001) at posttreatment. In addition, EAET was superior to CBT on 50% pain reduction (35% vs 7%; odds ratio, 11.77 [95% CI, 2.38-58.25]; P = .002), anxiety (estimate, -2.49 [95% CI, -4.30 to -0.68]; P = .006), depression (estimate, -3.06 [95% CI, -5.88 to -0.25]; P = .03), general life satisfaction (estimate, 1.23 [95% CI, 0.36-2.10]; P = .005), PTSD symptoms (estimate, -4.39 [95% CI, -8.44 to -0.34]; P = .03), PGIC score (estimate, 1.46 [95% CI, 0.77-2.15]; P < .001), and global treatment satisfaction (estimate, 0.28 [95% CI, 0.12-0.45]; P < .001) at posttreatment. Higher baseline depression (estimate, -1.55 [95% CI, -0.37 to 2.73]; P < .001), anxiety (estimate, -1.53 [95% CI, -2.19 to -0.88]; P < .001), and PTSD symptoms (estimate, -1.69 [95% CI, -2.96 to -0.42]; P = .009) moderated greater reduction in pain severity after EAET but not CBT. The results of this randomized clinical trial suggest that EAET may be a preferred intervention for medically and psychiatrically complex patients with pain. The societal burden of chronic pain could be improved by further incorporating the principles of EAET into mainstream clinical pain medicine. ClinicalTrials.gov Identifier: NCT03918642.

Intradermal Injection in Balding Region Versus Intramuscular Injection in Surrounding Muscles: A Split-Scalp, Randomized Trial on BoNT for Androgenetic Alopecia.

Recent advancements in androgenetic alopecia (AGA) treatment have highlighted the efficacy of botulinum toxin (BoNT). However, inconsistencies in injection sites and depths warrant attention. It remains unclear which injection strategy is most beneficial for patients. This split-scalp randomized controlled trial divided each enrolled participant's scalp along the midline: one side was randomized to receive intramuscular BoNT injections in the surrounding muscles, while the other side received intradermal BoNT injections directly into the balding areas. This study evaluated the impact of treatment on hair density and diameter through trichoscopic examinations conducted at baseline and 12weeks post treatment. Additionally, assessments of pain and overall safety were integrated into the study protocol. Twenty-nine patients completed the study, with significant improvements in hair density observed in the intramuscular injection group compared to the intradermal group (p < 0.001). Both groups exhibited increases in hair diameter, but no significant difference was found between the two methods (p = 0.433). Pain evaluation revealed that intradermal injections in balding areas were more painful than intramuscular injections (p = 0.036), with no severe adverse reactions reported except for a single case of alopecia areata following injection. Our research revealed that both BoNT injection strategies enhanced hair diameter 12weeks post-treatment, with intramuscular injections significantly improving hair density more effectively. Despite the promising outcomes, the variability in patient responses underscores the necessity for personalized approaches and further research to refine injection protocols for optimized efficacy and safety. ChiCTR2400080190.

The adherence and response of a combined approach of online self-help cognitive behavioral therapy and phone-based psychological guidance among French patients with cancer with insomnia.

12100 Background: Insomnia affects 30–60% of patients with cancer. Cognitive behavioral therapy for insomnia (CBT- I) is the gold-standard treatment for insomnia. However, the uptake of CBT-I in routine care remains low. Technology can be leveraged to facilitate the access and delivery of CBT-I. Nevertheless, adherence rates to online self-help interventions seem low (50-60%), and is associated with reduced intervention efficacy. The Sleep-4-All-2.0 is a prospective multicentric single arm study that evaluated an approach that combined a validated online self-help CBT-I program (Insomnet, 6 modules) to a phone-based guidance with a psychologist (3 orientation meetings). This study assessed: 1) how this combined approach performed in terms of adherence, behavior change and insomnia remission rates compared to prior literature investigating self-help CBT-I, and 2) the patients’ characteristics that are associated with a better or a poorer response. Methods: Data were collected with online questionnaires to compare outcomes: adherence (5 to 6 modules completed), behavior change (ad hoc questionnaire), insomnia remission (Insomnia Severity Index, ISI &lt; 8), sleep perception (ad hoc questionnaire), response to the program (changes in ISI score) at post intervention (week 6, 12 and 24). A descriptive analysis of patient characteristics at each time point was performed. Then, multivariate analyses were conducted: mixed models with a random effect at patient level (repeated measures) and fixed effects for the other variables. The following variables at baseline were used in the adjusted models: socio-demographic and clinical variables, ISI score, symptoms (ESAS), digital skills, barriers to change, motivation, social support and the referring professional. Results: Among the 348 patients included: 79% were women, 59% had breast cancer and 68% were undergoing treatment. A total of 310 patients (89%) initiated Insomnet. The adherence rate was 74% and 79% have changed their behavior. Insomnia remission rates were 34%, 46% and 50% at week 6, 12 and 24, respectively. Insomnia was no longer a problem for 48%, 63% and 66% at week 6, 12 and 24, respectively. Female gender (β=-1.22; p=0.05) and unemployed patients (β=-1.77; p&lt;0.01) were associated with a decrease in ISI scores. Sleep medication (β=1.58; p&lt;0.01), patients with a high sleepiness score (ESAS) (β=0.25; p=0.02) and patients with less digital skills (β=1.85; p&lt;0.01) were associated with an increase in ISI scores. Conclusions: A combination of online self-help CBT-I with phone-based guidance showed satisfactory rates of program adherence, change behavior and insomnia remission. However, some patient profiles such as the ones with lower digital skills and severe insomnia at baseline seemed to benefit less from this approach, and may require further care intensification. Clinical trial information: CONVENTION DE RECHERCHE no. 2020-1-PL SHS-03-IGR-1.

Effectiveness and safety of glecaprevir/pibrentasvir for 8 weeks in the treatment of patients with acute hepatitis C: A single-arm retrospective study.

No direct-acting antiviral is currently approved for acute HCV infection, delaying treatment. We investigated the effectiveness and safety of 8-week glecaprevir/pibrentasvir (G/P) in patients with acute HCV infection. This noninterventional, single-arm, retrospective chart review was designed to enroll adults/adolescents with acute HCV infection. Analyses were conducted on a full analysis set (FAS; all enrolled) and modified FAS (FAS excluding nonvirologic failures). The primary end point (modified FAS) was sustained virologic response at posttreatment week 12 (SVR12) with superiority to 92.6% threshold determined by historic chronic HCV G/P SVR12 rates. Secondary end points (FAS) included SVR12, on-treatment virologic failure, posttreatment relapse, and reinfection. Adverse events and safety laboratory values were assessed.Overall, 202 adults were enrolled; in the modified FAS, 150/151 (99.3%; 95% CI: 96.3-99.9) achieved SVR12, demonstrating superiority to efficacy threshold. In the FAS, the SVR12 rate was 74.3% and the on-treatment virologic failure rate was 0%. Relapse and reinfection rates after the final treatment visit (FAS) were 0.5% and 3%, respectively; 39 patients had missing SVR12 data. No on-treatment alanine aminotransferase elevations > 3 × upper limit of normal with total bilirubin > 2 × upper limit of normal were reported. All 53 patients with alanine aminotransferase Grade ≥ 2 at baseline improved to Grade 0/1 on treatment. No adverse eventss of hepatic decompensation/failure or leading to G/P discontinuation occurred. Two patients had serious adverse events unrelated to G/P. Eight-week G/P therapy was effective and well-tolerated in patients with acute HCV infection. Data support further investigation of G/P in acute HCV to shorten care cascades, reduce transmission, and support HCV elimination.

Comparison of externally and internally guided dance movement to address mobility, cognition, and psychosocial function in people with Parkinson's disease and freezing of gait: a case series.

The aim of this study is to explore the impact of internally guided (IG) versus externally guided (EG) adapted tango (AT) dance training (i.e., dancing the IG "Leader" role or the EG "Follower" role), on motor and non-motor functions in individuals with Parkinson's disease and freezing of gait (PD-FOG). The "Leader" role, a proxy for IG movements, conveys direction, timing, and amplitude of steps with tactile cues. The "Follower" role, a proxy for EG movements, detects and responds to the leader's tactile cues. Six participants were randomly assigned to the IG ("Leader") or EG ("Follower") roles for 20, 90-min AT lessons over 12 weeks. Participants were assessed for PD-specific and non-PD-specific functions before and twice after the end of the 12-week intervention, at 1-week and 1-month post-intervention. EG participants improved and/or maintained performance on more outcomes across all domains than IG participants. Five participants improved in PD motor symptoms, dynamic gait, global cognitive function, and the FOG Questionnaire immediately or 1 month after intervention. All participants expressed positive attitudes toward the intervention, including improvements in walking, balance, and endurance. AT training in the follower role may benefit individuals with PD-FOG to a greater extent compared to the leader role. This case series study could inform additional research with the goal of enhancing physical therapy or music-based therapy approaches for addressing PD-FOG.