scholarly journals Improving social function with real-world social-cognitive remediation in schizophrenia: Results from the RemedRugby quasi-experimental trial

2020 ◽  
Vol 63 (1) ◽  
Author(s):  
Julien Dubreucq ◽  
Franck Gabayet ◽  
Bernard Ycart ◽  
Megane Faraldo ◽  
Fanny Melis ◽  
...  

Abstract Background. Functional capacity (FC) has been identified as a key outcome to improve real-world functioning in schizophrenia. FC is influenced by cognitive impairments, negative symptoms, self-stigma and reduced physical activity (PA). Psychosocial interventions targeting FC are still under-developed. Methods. we conducted a quasi-experimental study evaluating the effects of an exercise-enriched integrated social cognitive remediation (SCR) intervention (RemedRugby [RR]) compared with an active control group practicing Touch Rugby (TR). To our knowledge, this is the first trial to date evaluating the effectiveness of such a program provided in a real-life environment. Results. Eighty-seven people with schizophrenia were included and allocated to either the RR group (n = 57) or the TR group (n = 30) according to the routine clinical practice of the recruiting center. Outcomes were evaluated at baseline and post-treatment in both groups and after 6 months of follow-up in the RR group using standardized scales for symptom severity, social functioning, self-stigma, and a large cognitive battery. After treatment we observed moderate to large improvements in social function (Personal and Social Performance Scale [PSP], p < 0.001, d = 1.255), symptom severity (Positive and Negative Syndrome Scale [PANSS] negative, p < 0.001, d = 0.827; PANSS GP, p < 0.001, d = 0.991; PANSS positive, p = 0.009, d = 0.594), verbal abstraction (p = 0.008, d = 0.554), aggression bias (p = 0.008, d = 0.627), and self-stigma (stereotype endorsement, p = 0.019, d = 0.495; discrimination experiences, p = 0.047; d = 0.389) that were specific to the RR group and were not observed in participants playing only TR. Effects were persistent over time and even larger between post-treatment and follow-up. Conclusions. Exercise-enriched integrated SCR appears promising to improve real-life functioning in schizophrenia. Future research should investigate the potential effects of this intervention on neuroplasticity and physical fitness.

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S249-S249
Author(s):  
Louise Birkedal Glenthoej ◽  
Mariegaard Lise ◽  
Birgitte Fagerlund ◽  
Jens Richardt Jepsen ◽  
Tina Dam Kristensen ◽  
...  

Abstract Background Individuals at ultra-high risk (UHR) for psychosis display significant cognitive deficits that constitute a barrier to functional recovery. Applying cognitive remediation (CR) before the onset of manifest psychosis may improve cognition and the clinical and functional prognosis of UHR individuals. Methods This randomised, clinical trial randomly assigned 146 UHR individuals aged 18–40 years to treatment as usual (TAU) or TAU plus cognitive remediation. The cognitive remediation consisted of 20-weeks of neurocognitive and social cognitive remediation. Assessments were carried out at 6- and 12-months post baseline. Primary outcome was composite score on the Brief Assessment of Cognition in Schizophrenia (BACS) battery at 6-months. Results Between April 2014 and January 2017, 73 UHR individuals were assigned to TAU and 73 were assigned to TAU + cognitive remediation. Compared to the control group, cognitive remediation did not result in significant improvement on the BACS composite score at 6-month follow-up (b=-0.125, 95%CI: -0.23 to 0.172, p=0.41). Nor did the intervention improve secondary outcomes in clinical symptoms or functioning. Exploratory analyses found emotion recognition latencies to be significantly more reduced in the intervention group than the TAU group at 6-months follow-up. At 12-month follow-up the intervention group exhibited significantly better performance on two exploratory outcomes of executive function and visual memory. The participants in the intervention group attended an average of 12 sessions out of 20. No adverse events were reported relating to the intervention. Discussion While the brief course of treatment did not impact global cognition, symptoms and functioning measures, treatment related benefit was found in exploratory component neuro- and social cognitive measures. Future studies should evaluate whether more personalized interventions such as the separate application of neurocognitive and social cognitive remediation may produce beneficial effect on cognition and functioning compared to treatment as usual, along with establishing the optimal number of training hours to produce cognitive and functional gains.


2021 ◽  
Vol 10 (7) ◽  
pp. 1511
Author(s):  
Katherine Nameth ◽  
Theresa Brown ◽  
Kim Bullock ◽  
Sarah Adler ◽  
Giuseppe Riva ◽  
...  

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Innovative interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient university eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients were enrolled; nine (82%) completed treatment; and 82% (9/11) provided follow-up data 7.1 (SD = 2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p < 0.001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of effectiveness. Findings, including some loss of treatment gains during follow-up may inform future treatment development.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4762-4762
Author(s):  
Herve Ghesquieres ◽  
Cedric Rossi ◽  
Fanny Cherblanc ◽  
Sandra Le Guyader ◽  
Fontanet Bijou ◽  
...  

Introduction: Lymphoma incidence continues to rise in France since early 80', although differently among subtypes. Recent improvements in patient survival in major lymphoma subtypes at populational level raise new questions about patient outcome (in specific subgroups) and survivorship (i.e. quality of life, long term sequelae). Numerous epidemiological studies have investigated factors related to lymphoma risk, but far fewer have addressed the extent to which socioeconomic status, social institutional context (i.e. healthcare system), social relationships, environmental context (exposures), individual behaviours (lifestyle) or genetic determinants influence lymphoma outcomes, especially in the general population. Moreover, the knowledge of the disease behaviour achieved from clinical trials data is partly biased because of patient selection. Study Design and Methods: The REALYSA ("REal world dAta in LYmphoma and Survival in Adults") study is a real-life multicentric cohort set in France areas mostly covered by population-based cancer registries to study the prognostic value of epidemiological, clinical and biological factors with a prospective 9-year follow up. ClinicalTrials.gov identifier is NCT03869619. We aim to include 6000 patients over 4 years. Adult patients without lymphoma history and newly diagnosed of one of the following 7 lymphoma subtypes (diffuse large B cell (DLBCL), follicular (FL), marginal zone (MZL), mantle cell (MCL), Burkitt, Hodgkin (HL), T-cell (T-NHL)) are offered to participate during a medical consultation with their hematologist. Exclusion criteria are: having already received anti-lymphoma treatment (except pre-phase) and having a documented HIV infection. After having given signed informed consent, participants fill in three auto-questionnaires regarding lifelong history of residences and occupations, quality of life (QoL / QLQ-C30 questionnaire) and social support (SS / SSQ6 questionnaire). Patients are then interviewed to collect their sociodemographic characteristics, medical and familial history, professional and domestic exposures to major chemicals and pesticides, lifestyle and women health. Clinical data are obtained using patients medical records, including care pathway, medical history, concomitant treatments, initial diagnosis characteristics, nodal/extra-nodal involvement, exams performed, staging, laboratory data, serologic tests, geriatric screening (G8 questionnaire), treatments received (including pre-phase, detailed treatment phases and molecules, reasons for treatment discontinuation), progressions, and treatment response evaluation. Biological samples at baseline and during treatment are collected including plasma and peripheral mononuclear cells. Additionally, a virtual tumor biobank is constituted for baseline tumor samples. The diagnosis will be ensured thanks to the review of French Lymphopath network. Follow-up, including clinical outcomes, new morbidities, lifestyle, professional situation, QoL, SS, fertility, health behavior, are collected every 6 months in the first 3 years and every year thereafter. Results: A pilot phase was implemented between November 2018 and June 2019 in 7 French hospitals/clinics. By June 30, 328 patients were recruited. Biological samples at baseline were obtained for 81% of included patients (n=265). 52% were male and 48% were female. The median age was 62 years (range: 18-95). The histological subtypes were the following (n=308 patients with complete data): 132 DLBCL (42.8%); 59 FL (19.5%); 52 HL (16.9%); 29 MCL (9.4%); 22 MZL (7.1%); 13 T-NHL (4.2%); 1 other (0.3%). We observed a good adherence to clinical research process despite the complexity of data collection. An extension phase with 10 additional centres will be launched during the last 2019 trimester. Discussion: The pilot phase of REALYSA study showed a good compliance to study guidelines and a good quality of data collected at baseline. Consequently, the study design is prospectively feasible in real-life setting. This cohort will constitute an innovative platform for clinical, biological, epidemiological and socio-economical research projects. Disclosures Oberic: Takeda: Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria; Roche: Membership on an entity's Board of Directors or advisory committees. Salles:Amgen: Honoraria, Other: Educational events; Novartis, Servier, AbbVie, Karyopharm, Kite, MorphoSys: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; BMS: Honoraria; Roche, Janssen, Gilead, Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Educational events; Merck: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Autolus: Consultancy, Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy, Honoraria.


Author(s):  
Gabriel Chodick ◽  
Lilac Tene ◽  
Tal Patalon ◽  
Sivan Gazit ◽  
Amir Ben Tov ◽  
...  

AbstractBackgroundBNT162b2 vaccines showed high efficacy against COVID-19 in a randomised controlled phase-III trial. A vaccine effectiveness evaluation in real life settings is urgently needed, especially given the global disease surge. Hence, we assessed the short-term effectiveness of the first dose of BNT162b2-vaccine against SARS-CoV-2 infection. Given the BNT162b2 Phase-III results, we hypothesized that the cumulative incidence of SARS-CoV-2 infection among vaccinees will decline after 12 days following immunization compared to the incidence during the preceding days.MethodsWe conducted a retrospective cohort study using data from 2·6 million-member state-mandated health provider in Israel. Study population consisted of all members aged 16 or above years who were vaccinated with BNT162b2-vaccine between December/19/2020 and January/15/2021. We collected information regarding medical history and positive SARS-CoV-2 polymerase chain reaction test from days after first dose to January/17/2021. Daily and cumulative infection rates in days 13-24 were compared to days 1-12 after first dose using Kaplan-Meier survival analysis and generalized linear models.FindingsData of 503,875 individuals (mean age 59·7 years SD=14·7, 47·8% males) were analysed, of whom 351,897 had 13-24 days of follow-up. The cumulative incidence of SARS-CoV-2 infection was 0·57% (n=2484) during days 1-12 and 0·27% (n=614) in days 13-24. A 51·4% relative risk reduction (RRR) was calculated in weighted-average daily incidence of SARS-CoV-2 infection from 43·41-per-100,000(SE=12·07) in days 1-12 to 21·08-per-100,000(SE=6·16) in days 13-24 following immunization. The decrement in incidence was evident from day 18 after first dose. Similar RRRs were calculated in individuals aged 60 or above (44.5%), younger individuals (50.2%), females (50.0%) and males (52.1%). Findings were similar in sub-populations and patients with various comorbidities.ConclusionsWe demonstrated an effectiveness of 51% of BNT162b2 vaccine against SARS-CoV-2 infection 13-24 days after immunization with the first dose. Immunization with the second dose should be continued to attain the anticipated protection.Research in contextEvidence before this studyWe searched PubMed for follow-up studies regarding the effectiveness of BNT162b2 mRNA Covid-19 Vaccine without any language restrictions. The search terms were (BNT162b2 OR mRNA Covid-19 Vaccine) AND (effectiveness OR real-world OR phase IV) until Jan 15, 2021. We found no relevant observational studies among humans. We also assessed Phase II and Phase III clinical trials with BNT162b2 mRNA vaccine.Added value of this studyTo our knowledge, this is the first and largest phase IV study on the effectiveness of the BNT162b2 mRNA COVID-19 vaccine in real-world settings. Our findings showed that the first dose of the vaccine is associated with an approximately 51% reduction in the incidence of PCR-confirmed SARS-CoV-2 infections at 13 to 24 days after immunization compared to the rate during the first 12 days. Similar levels of effectiveness were found across age groups, sex, as well as among individuals residing in Arab or ultra-orthodox Jewish communities that display an increased COVID-19 risk.Implications of all the available evidenceThe study results indicate that in real life the first dose of the new BNT162b2 mRNA COVID-19 vaccine confers around 50% protection against overall SARS-CoV-2 infections (symptomatic or asymptomatic). Together our findings and the 95% efficacy shown in the phase III trial, suggest that the BNT162b2 vaccine should be administered in two doses to achieve maximum protection and impact in terms of disease burden reduction and possibly reducing SARS-CoV-2 transmission. COVID-19 vaccines should be urgently deployed globally.


Author(s):  
Katherine Nameth ◽  
Theresa Brown ◽  
Kim Bullock ◽  
Sarah Adler ◽  
Giuseppe Riva ◽  
...  

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Novel interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient University eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients enrolled; nine (82%) completed treatment; 82% (9/11) provided follow-up data 7.1 (SD=2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p &amp;lt; .001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of efficacy. Findings, including some loss of treatment gains during follow-up may inform future treatment development.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3735-3735
Author(s):  
Davide Rossi ◽  
Holger Hebart ◽  
Christoph Losem ◽  
Thomas Wolff ◽  
Xenia Schmidt ◽  
...  

Abstract Background In clinical trials, venetoclax has shown high efficacy and good tolerability in patients with chronic lymphocytic leukemia (CLL). Retrospective cohort studies have examined outcomes with venetoclax in B-cell receptor pathway inhibitor (BCRi) naïve and exposed patients with relapsed/refractory (R/R) CLL in the real world setting. However, prospective real-world data on the sequencing of new agents in the R/R setting are limited. The prospective non-interventional observational study VeRVe is assessing effectiveness, safety, and quality of life in CLL patients treated with venetoclax in Austria, Germany, and Switzerland according to local label. Here we report outcomes in patients treated with venetoclax in combination with rituximab (VenR) in BCRi-naïve and BCRi-exposed patients. Methods Adult patients with CLL requiring therapy treated with VenR according to local label were included in this analysis. Patient visits are scheduled at the physician's discretion and according to clinical practice. Study documentation is possible at baseline, weekly during ramp-up, monthly until the end of 6 months and 3-monthly afterwards up to a maximum of 3 years. Response assessment according to iwCLL criteria can be documented at the end of ramp-up, after 3, 12, and 24 months. Analyses were performed for subgroups of BCRi-naïve and BCRi-exposed patients. Results Until April 26, 2021, 94 patients treated with VenR had been enrolled in the ongoing study and had received at least one dose of venetoclax (safety population). For 72 patients, treatment response had been documented at least once (effectiveness population). Enrolled patients had a median of 1 (range 1-10) previous lines of therapy. 57 patients (61%) had previously been treated with chemoimmunotherapy (CIT) and were BCRi-naïve, 32 patients (34%) had received at least one prior BCRi and 7 (7%) had received other prior treatment options. BCRi-naïve patients had a median of 1 prior therapies (range 1-4), while BCRi-exposed patients had received a median of 3 prior therapies (range 1-10). Risk factors were more common in the BCRi-exposed group (38% of patients had a documented del(17p), 34% a TP53 mutation, and 41% an unmutated IGHV status) in comparison to the BCRi-naïve group (14% del(17p), 16% TP53 mutation and 40% unmutated IGHV). Median age at baseline was 72 and 71 years for BCRi-naïve and BCRi-exposed patients, respectively. 65% vs. 84% of BCRi-naive and BCRi-exposed patients had at least one comorbidity. In the BCRi-exposed group, 29 patients (91%) had a BCRi as last prior therapy before VenR initiation with a median duration of prior BCRi therapy of 18 months (range 1 - 61 month). Most frequent reasons for discontinuation of prior BCRi therapy were AE/SAE (11 patients) and disease progression (12 patients). The reported best overall response at 12 months after VenR initiation was 83% (CR+CRi 55%; PR: 28%) for BCRi-naïve and 85% (CR+CRi 30%; PR: 55%) for BCRi-exposed patients (figure 1). After a median follow-up of 315 days the estimated 12-months OS and PFS rate were both 94.8% for BCRi-naïve patients, whereas the estimated 12 months OS and PFS rate for BCRi-exposed patients were 79.1% and 75.7%, respectively, with a median follow-up of 371 days. 79% / 25% of BCRi-naïve and 90% / 44% of BCRi-exposed patients had AEs / SAEs. No new safety signals were observed. Conclusion In this analysis of real-world use of venetoclax in R/R CLL, patients receiving venetoclax in combination with rituximab were predominantly BCRi-naïve. BCRi-exposed patients were more heavily pre-treated, exhibited more genetic high-risk factors, and a higher proportion of patients with comorbidities. Yet, these patients achieved comparable overall response rates. However, complete remissions were more common and the 12 months OS and PFS rates were higher in BCRi-naïve patients. In both groups, VenR treatment was well tolerated. VenR represents a suitable treatment option in BCRi-naïve as well as BCRi-exposed patients. Figure 1 Figure 1. Disclosures Rossi: Gilead: Honoraria, Research Funding; AstraZeneca: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Verastem: Honoraria, Research Funding; Roche: Honoraria, Research Funding; Abbvie: Honoraria, Research Funding; Cellestia: Honoraria, Research Funding. Hebart: AstraZeneca: Honoraria; Janssen: Honoraria; BMS: Honoraria; AbbVie: Honoraria; Roche: Honoraria. Losem: AbbVie: Honoraria; Amgen: Honoraria. Wolff: Bayer: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; Teva: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; AstraZeneca: Honoraria, Research Funding; Roche: Honoraria, Research Funding. Schmidt: AbbVie: Current Employment. Famulla: AbbVie: Current Employment. Schmidt: Takeda: Honoraria; Biotest: Honoraria; Alexion: Honoraria; Sanofi-Aventis: Honoraria; Novartis: Honoraria; Incyte: Honoraria; AbbVie: Honoraria; Janssen: Honoraria. Noesslinger: Jansen: Honoraria; Roche: Honoraria; Celgene: Honoraria; Gilead: Honoraria; AstraZeneca: Honoraria; AbbVie: Honoraria. Schwaner: AbbVie: Honoraria; Amgen: Honoraria; AstraZeneca: Honoraria; Celgene: Honoraria; Janssen: Honoraria; Novartis: Honoraria; Roche: Honoraria; Servier: Honoraria.


Author(s):  
Tarja Mälkönen ◽  
Pauliina Nuutinen ◽  
Taru Hallinen ◽  
Erkki Soini ◽  
Riikka Nissinen ◽  
...  

Guselkumab treatment outcomes and persistence were assessed in a real-world cohort of Finnish patients with difficult-to-treat plaque psoriasis over a median follow-up of 1 year. Data on 181 patients who initiated guselkumab at the 15 study centres were collected retrospectively from the patient charts. Prior exposure to biologic therapies was common with 56% and 35% having used at least 1 and 2 biologics, respectively. Median guselkumab treatment duration was 11 months with 21 patients (12%) discontinuing treatment during follow-up. Of 85 patients with a follow-up duration of at least 1 year, 73 (86%) were still on guselkumab at 1 year. Significant improvements during follow-up were seen in the absolute Psoriasis Area and Severity Index (PASI) scores with 32 patients (80%) having absolute PASI ≤ 2 after a 9–14-month treatment. Guselkumab treatment was effective and treatment persistence was high in the nationwide Finnish real-life setting.


2013 ◽  
Vol 47 (6) ◽  
pp. 512-515 ◽  
Author(s):  
Pamela Jane Marsh ◽  
Robyn Langdon ◽  
Anthony Harris ◽  
Max Coltheart

2017 ◽  
Vol 47 (15) ◽  
pp. 2720-2730 ◽  
Author(s):  
C. Reeder ◽  
V. Huddy ◽  
M. Cella ◽  
R. Taylor ◽  
K. Greenwood ◽  
...  

BackgroundCognitive remediation (CR) is a psychological therapy, which improves cognitive and social functioning in people with schizophrenia. It is now being implemented within routine clinical services and mechanisms of change are being explored. We designed a new generation computerised CR programme, CIRCuiTS (Computerised Interactive Remediation of Cognition – a Training for Schizophrenia), to enhance strategic and metacognitive processing, with an integrated focus on the transfer of cognitive skills to daily living. This large trial tested its feasibility to be delivered in therapist-led and independent sessions, and its efficacy for improved cognitive and social functioning.MethodsA two arm single blind randomised superiority trial comparing CIRCuiTS plus treatment-as-usual (TAU) with TAU alone in 93 people with a diagnosis of schizophrenia. Cognitive, social functioning and symptom outcomes were assessed at pre- and post-therapy and 3 months later.Results85% adhered to CIRCuiTS, completing a median of 28 sessions. There were significant improvements in visual memory at post-treatment (p = 0.009) and follow-up (p = 0.001), and a trend for improvements in executive function at post-treatment (p = 0.056) in favour of the CIRCuiTS group. Community function was also differentially and significantly improved in the CIRCuiTS group at post-treatment (p = 0.003) but not follow-up, and was specifically predicted by improved executive functions.ConclusionsCIRCuiTS was beneficial for improving memory and social functioning. Improved executive functioning emerges as a consistent predictor of functional gains and should be considered an important CR target to achieve functional change. A larger-scale effectiveness trial of CIRCuiTS is now indicated.


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