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Background: Older adults with advanced dementia require significant care, leading to high stress levels in caregivers. Objectives: The current study aimed to evaluate the effects of an Integrative Stress Reduction Program on Thai caregiver's outcomes of stress, sleep quality, and caregiver-assessed neuropsychiatric symptoms of persons with dementia. Methods: A single-blind randomized-controlled trial was conducted. A sample of family caregivers of people with dementia was recruited from memory clinics at outpatient community health centers in Thailand and randomly assigned to the experimental and control groups. Participants in the experimental group were enrolled in 5 intervention sessions over 4 weeks, while the control group received usual care. Outcome variables were collected at baseline, 4 weeks postintervention, and 8 weeks of follow-up. Results: Compared with the control group, caregivers in the experimental group (n = 27) had significantly decreased stress (p <.01) and better sleep quality (p <.01), and caregivers reported that their family members with dementia (n = 27) had decreased neuropsychiatric symptoms (p <.01) after the intervention (week 4) and at the 8-week follow-up. Conclusions: The Integrative Stress Reduction Program improved outcomes for caregivers and decreased neuropsychiatric symptoms in people with dementia. [ABSTRACT FROM AUTHOR]

Background: The loss of a sibling can have a long-term impact on the mental and physical health of the surviving sibling throughout adolescence and later adulthood. Even though bereaved siblings can be identified as a high-risk group, evidence-based interventions for this bereavement group are still missing. Aim: To evaluate the treatment effects of an internet-based writing intervention for bereaved siblings aged 16–65 years. Design: A two-armed randomized controlled trial (DRKS00011514) compared the intervention to a waiting list control group. The 6-week intervention consisted of six structured writing assignments that were based on cognitive behavioral therapy, focusing on the specific situation of bereaved siblings. Setting/participants: Eighty-six bereaved siblings (loss >1 month ago, no severe psychiatric symptoms) were randomly allocated to the intervention group (n = 47) or the waiting list control group (n = 39). Primary outcomes were symptoms of prolonged grief disorder and depression; secondary outcomes were posttraumatic stress symptoms and survivor guilt. Results: Symptoms of depression and prolonged grief disorder improved significantly in the intention-to-treat analyses from pre-to post-measurement compared with the control group (g Depression = −0.62, g Grief = 0.33). In the intervention group, all primary and secondary outcomes decreased significantly from baseline to 12-month follow-up (g s = −0.38 to −1.04). A significant clinical change could be found for depression (34%) compared to the waitlist control group (10%). Conclusions: Bereaved siblings profited from this brief internet-based writing intervention in the short- and long-term. However, future research, such as dismantling studies, may help to further optimize the benefits of an intervention aimed at bereaved siblings. [ABSTRACT FROM AUTHOR]

Although it is well established that college entrance exams have become a key factor for admission to selective institutions, less is known about the influence of test scores in relation to other academic factors in the evaluation of a student's application file. This study conducts a randomized-controlled trial to determine whether providing students' test scores in context—how they perform relative to their school and neighborhood peers—increases the likelihood that admission officers (n = 321) would recommend admitting low-socioeconomic status (SES) applicants. The study also examines how including a personal admission essay that conveys grit, or ability to persevere in the pursuit of long-term goals, influences admission decision making. Admission officers in the contextual condition were significantly more likely to accept both the low-SES and high-SES applicant than those without contextual information on test scores; however, they were not more likely to accept applicants who convey grit in their personal essays. [ABSTRACT FROM AUTHOR]

Objective: To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. Methods/design: We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. Discussion: This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS. Trial registration: ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019. [ABSTRACT FROM AUTHOR]

Objective: Physical functioning is closely associated with cognition. The current study assessed the impact of three cognitive training programs on objective measures of physical functioning across 5 years. Method: Older adults randomized to a processing speed (n = 702), reasoning (n = 694), or memory (n = 703) training intervention were compared with those randomized to a no-contact control condition (n = 698). Intention-to-treat (ITT) and treatment-received/dosage (time-varying number of training sessions) analyses were conducted. Results: There were no transfer effects in the ITT analyses. Treatment-received models demonstrated that training sessions (i.e., higher dosage) across all intervention arms transferred to better maintained Digit Symbol Copy and Turn 360 performance relative to the control group. More reasoning training transferred to better grip strength. Discussion: This is the first study to demonstrate differential longitudinal cognitive training transfer effects to three performance-based physical functioning measures. Future research should investigate mechanisms of far-transfer effects. [ABSTRACT FROM AUTHOR]

This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or Skillstreaming. Groups were matched on parent and child demographics, and intervention staff training. Participants were assessed on social behavior during treatment sessions, peer sociometrics, staff-reported social skills, and parent-reported social skill generalization. Results indicated that both groups increased in reciprocated friendship nominations and staff-reported social skills. Relative to Skillstreaming participants, SDARI participants liked and interacted more with each other after a single session. However, Skillstreaming participants increased in peer liking and interaction over the course of the intervention; SDARI participants decreased slightly. Parents reported no change in social functioning at home. Implications for research and practice are discussed. [ABSTRACT FROM PUBLISHER]

Reperfusion in ischemic stroke can be pursued by either systemic intravenous thrombolysis or endovascular treatment. However, systemic intravenous thrombolysis with alteplase within 4·5 h of symptom onset in selected patients is the only medication of proven efficacy. No randomized-controlled trials have so far compared the two modalities. To explore this, after a pilot phase, we started the SYNTHESIS Expansion trial. To determine whether endovascular treatment (i.e., intra-arterial thrombolysis with alteplase - if necessary, associated to or substituted by mechanical clot disruption and/or retrieval) compared with systemic intravenous thrombolysis with alteplase, administered according to European labelling, increases the proportion of independent survivors at three-months. SYNTHESIS Expansion is an open-label, multicenter randomized-controlled trial, with blinded follow-up. Eligibility applies to; patients with symptomatic ischemic stroke, seen within 4·5 h of onset; being able to initiate intravenous alteplase immediately, and endovascular treatment as soon as possible (not later than six-hours of stroke onset). The study is pragmatically based on the 'uncertainty principle' between endovascular treatment and systemic intravenous thrombolysis for patients eligible for intravenous alteplase. There are no prespecified clinical or instrumental criteria to further select a patient, although investigators are left free to use them. Enrollment will be completed with 350 randomized patients. Primary analysis is on an intent-to-treat basis. Primary: modified Rankin scale score of 0 or 1 at three-months. Secondary: neurological deficit seven-days after thrombolysis and the safety of the procedure on the basis of events reported within seven-days following thrombolysis - symptomatic cerebral hemorrhage, fatal and nonfatal stroke, death from any cause, neurological deterioration. [ABSTRACT FROM AUTHOR]

Rationale Selective Serotonin Reuptake Inhibitors ( SSRI) are effective in the treatment of post-stroke depression and may have potential neuroprotective and vascular effects. Data from registry studies have further indicated a protective effect against recurrent ischemic events, but also an increased risk of bleeding in patients with ischemic stroke. Therefore, prospective studies are needed to determine the effects of SSRI treatment after acute ischemic stroke. Aims and design TALOS is an investigator-initiated, national multicenter randomized- and placebo-controlled, double-blind trial testing citalopram in acute ischemic stroke. We hypothesize that citalopram treatment initiated in the acute phase after ischemic stroke will improve outcome assessed by the modified Rankin Score ( mRS) and reduce the risk of death from vascular causes, transient ischemic attack ( TIA)/stroke and myocardial infarction. Study outcomes There are two co-primary effect variables: (i) Functional status at six-months, measured by the modified Rankin Scale, and (ii) Vascular death, TIA/stroke and myocardial infarction. Secondary effect variables include: (i) Single primary outcomes; (ii) The Barthel Index; (iii) Mini Mental State Examination at six-months; (iv) Final infarct size (Magnetic Resonance Imaging). Discussion SSRI treatment is well tolerated and overall beneficial in the wake of stroke; it may also be neuroprotective and prevent new vascular events. [ABSTRACT FROM AUTHOR]