scholarly journals Online Mindfulness Stress Intervention for Family Carers of Children and Adults with Intellectual Disabilities: Feasibility Randomized Controlled Trial

Mindfulness ◽  
2020 ◽  
Vol 11 (9) ◽  
pp. 2161-2175
Author(s):  
Samantha Flynn ◽  
Richard P. Hastings ◽  
Christine Burke ◽  
Simon Howes ◽  
Yona Lunsky ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intellectual Disabilities ◽  
Study Design ◽  
Controlled Trial ◽  
Cost Effective ◽  
Telephone Support ◽  
Family Carers ◽  
Structured Interviews ◽  
Post Intervention ◽  
Randomized Controlled

Abstract Objectives Family carers of people with intellectual disabilities (ID) are twice as likely as other carers to experience stress and mental ill-health, but research exploring interventions is sparse. Online mindfulness may provide an accessible, cost-effective resource. The addition of guided telephone support could help to tailor an existing intervention for this population. A feasibility randomized controlled trial (RCT) was conducted to inform the development of a definitive RCT. Methods Sixty participants were randomized to complete Be Mindful (a brief online mindfulness intervention) either with or without additional Peer Mentor support. Feasibility of recruitment, retention, intervention adherence, and acceptability of study design was examined. Preliminary analyses were undertaken on participant-reported outcomes pre- and post-intervention. Eighteen semi-structured interviews were conducted as a process evaluation. Results Feasibility outcomes indicate that it would be possible to recruit and retain (88%) participants to a definitive RCT, and that the study design and intervention are acceptable. The addition of guided telephone support was not burdensome; indeed, it was additionally motivating. Telephone support can be delivered with high fidelity, but this is inconsistent and requires further piloting. Preliminary comparison data indicate small, but non-significant, improvements for participants receiving guided telephone support relative to those who did not over time. Conclusions It is feasible to deliver online mindfulness with additional telephone-guided support to family carers of people with ID, and this may lead to small benefits over receiving online mindfulness alone. A definitive RCT can be planned to examine the effectiveness and cost-effectiveness of this intervention.

scholarly journals Effectiveness of the serious game ‘You & I’ in changing mentalizing abilities of adults with mild to borderline intellectual disabilities: A parallel superiority randomized controlled trial

2019 ◽  
Author(s):  
S.D.M. Derks ◽  
S. van Wijngaarden ◽  
M. Wouda ◽  
C. Schuengel ◽  
P.S. Sterkenburg
Keyword(s):  
Randomized Controlled Trial ◽  
Intellectual Disabilities ◽  
Social Relationships ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Serious Game ◽  
Post Intervention ◽  
Stress Regulation ◽  
Randomized Controlled

Abstract Background: Persons with mild to borderline intellectual disabilities generally show dysfunctions in mentalization and stress regulation, resulting in problematic social relationships and personal distress. Intervention programs may improve mentalizing abilities. The aim of this study is to examine the effectiveness of the serious game ‘You & I’ in changing mentalizing abilities and stress regulation in adults with mild to borderline intellectual disabilities. Methods: A two-arm, parallel, superiority randomized controlled trial will be used with 172 adults with mild to borderline intellectual disabilities. Participants will be randomly assigned to either the experimental group to play the serious game ‘You & I’ or to a waitlist control group. Participants will be assessed at baseline, post-intervention (5 weeks after baseline), and follow-up (6 to 8 weeks after post-intervention). They also will fill in questionnaires for personal factors, personal development, personal well-being, social validity, autism spectrum quotient (demographic variables), mentalizing abilities (primary outcome measure), and stress regulation (secondary outcome measure). Discussion: The serious game ‘You & I’ aims to improve mentalizing abilities in adults with mild to borderline intellectual disabilities, which is expected to lead to improved regulation of stress in social relationships. The study’s unique feature is the use of a serious game to improve mentalizing abilities. If the intervention is effective, the serious game can be implemented on a broad scale in Dutch care organizations for people with intellectual disabilities as an effective preventive tool to improve mentalizing abilities.

scholarly journals Effectiveness of the serious game ‘You & I’ on the mentalizing abilities of adults with mild to borderline intellectual disabilities: a parallel superiority randomized controlled trial

2019 ◽  
Author(s):  
S.D.M. Derks ◽  
S. van Wijngaarden ◽  
M. Wouda ◽  
C. Schuengel ◽  
P.S. Sterkenburg
Keyword(s):  
Randomized Controlled Trial ◽  
Intellectual Disabilities ◽  
Social Relationships ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Autism Spectrum ◽  
Serious Game ◽  
Post Intervention ◽  
Stress Regulation ◽  
Randomized Controlled

Abstract Background: Persons with mild to borderline intellectual disabilities generally show dysfunctions in mentalization, including impairments in stress regulation, resulting in problematic social relationships and personal distress. Inteention programs can, however, improve mentalizing abilities. The aim of this study is to examine the effectiveness of the serious game ‘You & I’ on mentalizing abilities and stress regulation in adults with mild to borderline intellectual disabilities. Methods: A two-arm, parallel, superiority randomized controlled trial will be used with 172 adults with mild to borderline intellectual disabilities. Participants will be randomly assigned to either the experimental group to play the serious game ‘You & I’ or a waitlist control group. Participants will be assessed at baseline, post-intervention (5 weeks after baseline), and follow-up (6 to 8 weeks after post-intervention). They also will fill in questionnaires measuring personal factors, personal development, and personal well-being, social validity, and autism spectrum quotient (demographic variables), mentalizing abilities (primary outcome measure), and stress regulation (secondary outcome measure). Discussion: The serious game ‘You & I’ aims to improve mentalizing abilities in adults with mild to borderline intellectual disabilities, which is expected to lead to improved regulation of stress in social relationships. The study’s unique feature is the use of a serious game to improve mentalizing abilities, which is expected to provide insight into the game’s effectiveness for adults with mild to borderline intellectual disabilities. If the intervention is effective, the serious game can be implemented on a broad scale in Dutch care organizations for people with intellectual disabilities as an effective tool to improve mentalizing abilities. It will be made available online, free of charge. Trial Registration: Nederlands Trial Register NTR7418 (registered 2 August 2018). Keywords: Mentalization, stress regulation, intellectual disability, serious game.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

2021 ◽  
pp. 154596832110231
Author(s):  
Kishoree Sangarapillai ◽  
Benjamin M. Norman ◽  
Quincy J. Almeida
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Randomized Controlled Trial ◽  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Motor Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

scholarly journals Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

2021 ◽  
Vol 18 (14) ◽  
pp. 7510
Author(s):  
Guillermo García Pérez de Sevilla ◽  
Olga Barceló Guido ◽  
María de la Paz De la Cruz ◽  
Ascensión Blanco Fernández ◽  
Lidia B. Alejo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Effect Size ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Nutrition Intervention ◽  
Sitting Time ◽  
Post Intervention ◽  
University Employees ◽  
Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

scholarly journals The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

2015 ◽  
Vol 31 (7) ◽  
pp. 1381-1394 ◽  
Author(s):  
Ana Carolina Barco Leme ◽  
Sonia Tucunduva Philippi
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Waist Circumference ◽  
Study Design ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Activity Level ◽  
Randomized Controlled ◽  
Healthy Habits ◽  
Design Protocol

The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

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