scholarly journals T46. THE EFFECT OF COMPREHENSIVE COGNITIVE REMEDIATION IN INDIVIDUALS AT ULTRA-HIGH RISK FOR PSYCHOSIS: A SINGLE-BLIND, RANDOMISED, CLINICAL TRIAL (FOCUS)

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S249-S249
Author(s):  
Louise Birkedal Glenthoej ◽  
Mariegaard Lise ◽  
Birgitte Fagerlund ◽  
Jens Richardt Jepsen ◽  
Tina Dam Kristensen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Social Cognitive ◽  
Intervention Group ◽  
Cognitive Remediation ◽  
Randomised Clinical Trial ◽  
Treatment As Usual ◽  
Ultra High Risk ◽  
Social Cognitive Remediation

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.

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 ◽  
...  
Keyword(s):  
Real World ◽  
Symptom Severity ◽  
Social Cognitive ◽  
Real Life ◽  
Cognitive Remediation ◽  
Social Function ◽  
Post Treatment ◽  
Quasi Experimental ◽  
Social Cognitive Remediation

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.

scholarly journals No Effects of Cognitive Remediation on Cerebral White Matter in Individuals at Ultra-High Risk for Psychosis—A Randomized Clinical Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Tina D. Kristensen ◽  
Bjørn H. Ebdrup ◽  
Carsten Hjorthøj ◽  
René C. W. Mandl ◽  
Jayachandra M. Raghava ◽  
...  
Keyword(s):  
Clinical Trial ◽  
White Matter ◽  
High Risk ◽  
Randomized Clinical Trial ◽  
Cognitive Remediation ◽  
Cerebral White Matter ◽  
Ultra High Risk

scholarly journals Effects of relaxation on depression levels in women with high-risk pregnancies: a randomised clinical trial

2016 ◽  
Vol 24 (0) ◽  
Author(s):  
Wanda Scherrer de Araújo ◽  
Walckiria Garcia Romero ◽  
Eliana Zandonade ◽  
Maria Helena Costa Amorim
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Intervention Group ◽  
Depression Scale ◽  
Randomised Clinical Trial ◽  
Nursing Intervention ◽  
Relaxation Technique ◽  
Control Group ◽  
Significance Level ◽  
Symptoms Of Depression

ABSTRACT Objective: to analyse the effects of relaxation as a nursing intervention on the depression levels of hospitalised women with high-risk pregnancies. Methods: a randomised clinical trial realised in a reference centre for high-risk pregnancies. The sample consisted of 50 women with high-risk pregnancies (25 in the control group and 25 in the intervention group). The Benson relaxation technique was applied to the intervention group for five days. Control variables were collected using a predesigned form, and the signs and symptoms of depression were evaluated using the Edinburgh Postnatal Depression Scale (EPDS). The Statistical Package for Social Sciences (SPSS), version 20.0, was used with a significance level of 5%. The Wilcoxon and paired t-tests were used to evaluate depression levels between two timepoints. Using categorical data, the McNemar test was used to analyse differences in depression severity before and after the intervention. Results: depression levels decreased in the intervention group five days after the relaxation technique was applied (4.5 ± 3, p<0.05) compared with the levels at the first timepoint (10.3±5.9). Conclusion: as a nursing intervention, relaxation was effective in decreasing the symptoms of depression in hospitalised women with high-risk pregnancies.

The effects of whole grain intake on anthropometric measures in overweight and obese children: a crossover randomised clinical trial

2021 ◽  
pp. 1-7
Author(s):  
Parisa Hajihashemi ◽  
Leila Azadbakht ◽  
Mahin Hashemipour ◽  
Roya Kelishadi ◽  
Parvane Saneei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Waist Circumference ◽  
Intervention Group ◽  
Randomised Clinical Trial ◽  
Slight Reduction ◽  
Whole Grain ◽  
Obese Children ◽  
Anthropometric Measures ◽  
Before And After ◽  
Grain Foods

Abstract Whole-grain foods have been reported to affect body weight and satiety. However, we are aware of no study in this regard among children. The present study aimed to determine the effects of whole grain consumption on anthropometric measures in overweight or obese children. In this randomised crossover clinical trial, forty-four overweight or obese girls participated. After a 2-week run-in period, subjects were randomly assigned to either intervention (n 44) or non-intervention (n 44) groups. Subjects in the intervention group were given a list of whole-grain foods and were asked to obtain half of their grain servings from these foods each day for 6 weeks. Individuals in the non-intervention group were asked not to consume any of these foods. A 4-week washout period was applied. Then, participants were crossed over to the alternate arm. The measurements were done before and after each phase. Mean age, weight and BMI of participants were 11·2 (sd 1·49) years, 51·2 (sd 10·2) kg and 23·5 (sd 2·5) kg/m2, respectively. Despite the slight reduction in weight and BMI, there were no significant differences in changes in these anthropometric measures. We found a significant effect of whole grain intake on waist circumference (−2·7 v. 0·3 cm, P = 0·04). No significant changes in hip circumference were observed. Changes in the prevalence of overweight, obesity and abdominal obesity were not significantly different. This study indicated a beneficial effect of whole-grain foods on waist circumference in overweight children; however, these foods did not influence weight and BMI.

Parental socioeconomic status and prognosis in individuals with ultra-high risk for psychosis: A 2-year follow-up study

2015 ◽  
Vol 168 (1-2) ◽  
pp. 56-61 ◽  
Author(s):  
Ji Won Hur ◽  
Soo-Hee Choi ◽  
Je-Yeon Yun ◽  
Myong-Wuk Chon ◽  
Jun Soo Kwon
Keyword(s):  
Socioeconomic Status ◽  
High Risk ◽  
Follow Up Study ◽  
Ultra High Risk ◽  
Parental Socioeconomic Status

scholarly journals Physical therapy plus general practitioners’ care versus general practitioners’ care alone for sciatica: a randomised clinical trial with a 12-month follow-up

2008 ◽  
Vol 17 (4) ◽  
pp. 509-517 ◽  
Author(s):  
Pim A. J. Luijsterburg ◽  
Arianne P. Verhagen ◽  
Raymond W. J. G. Ostelo ◽  
Hans J. M. M. van den Hoogen ◽  
Wilco C. Peul ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
General Practitioners ◽  
Randomised Clinical Trial

Depth of response and minimal residual disease status in ultra high-risk multiple myeloma and plasma cell leukemia treated with daratumumab, bortezomib, lenalidomide, cyclophosphamide and dexamethasone (Dara-CVRd): Results of the UK optimum/MUKnine trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8001-8001
Author(s):  
Martin F. Kaiser ◽  
Andrew Hall ◽  
Katrina Walker ◽  
Ruth De Tute ◽  
Sadie Roberts ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Minimal Residual Disease ◽  
Plasma Cell ◽  
Residual Disease ◽  
Cell Leukemia ◽  
Ultra High Risk ◽  
Grade 3 ◽  
Minimal Residual

8001 Background: Patients with ultra high-risk (UHiR) newly diagnosed multiple myeloma (NDMM) and patients with plasma cell leukemia (PCL) continue to have dismal outcomes and are underrepresented in clinical trials. Recently, improved responses with anti-CD38 monoclonal antibody combination therapy have been reported for NDMM patients. We report here outcomes for NDMM UHiR and PCL patients treated in the OPTIMUM/MUKnine (NCT03188172) trial with daratumumab, cyclophosphamide, bortezomib, lenalidomide, dexamethasone (Dara-CVRd) induction, augmented high-dose melphalan (HDMEL) and ASCT. With final analysis follow-up surpassed in Feb 2021, we report here early protocol defined endpoints from induction to day 100 post ASCT. Methods: Between Sep 2017 and Jul 2019, 107 patients with UHiR NDMM by central trial genetic (≥2 high risk lesions: t(4;14), t(14;16), t(14;20), gain(1q), del(1p), del(17p)) or gene expression SKY92 (SkylineDx) profiling, or with PCL (circulating plasmablasts > 20%) were included in OPTIMUM across 39 UK hospitals. Patients received up to 6 cycles of Dara-CVRd induction, HDMEL and ASCT augmented with bortezomib, followed by Dara-VR(d) consolidation for 18 cycles and Dara-R maintenance. Primary trial endpoints are minimal residual disease (MRD) status post ASCT and progression-free survival. Secondary endpoints include response, safety and quality of life. Data is complete but subject to further data cleaning prior to conference. Results: Median follow-up for the 107 patients in the safety population was 22.2 months (95% CI: 20.6 – 23.9). Two patients died during induction due to infection. Bone marrow aspirates suitable for MRD assessment by flow cytometry (10-5 sensitivity) were available for 81% of patients at end of induction and 78% at D100 post ASCT. Responses in the intention to treat population at end of induction were 94% ORR with 22% CR, 58% VGPR, 15% PR, 1% PD, 5% timepoint not reached (TNR; withdrew, became ineligible or died) and at D100 post ASCT 83% ORR with 47% CR, 32% VGPR, 5% PR, 7% PD, 10% TNR. MRD status was 41% MRDneg, 40% MRDpos and 19% not evaluable post induction and 64% MRDneg, 14% MRDpos and 22% not evaluable at D100 post ASCT. Responses at D100 post ASCT were lower in PCL with 22% CR, 22% VGPR, 22% PR, 22% PD, 12% TNR. Most frequent grade 3/4 AEs during induction were neutropenia (21%), thrombocytopenia (12%) and infection (12%). Grade 3 neuropathy rate was 3.7%. Conclusions: This is to our knowledge the first report on a trial for UHiR NDMM and PCL investigating Dara-CVRd induction and augmented ASCT. Response rates were high in this difficult-to-treat patient population, with toxicity comparable to other induction regimens. However, some early progressions highlight the need for innovative approaches to UHiR NDMM. Clinical trial information: NCT03188172.

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