scholarly journals Peer group-based online intervention program to empower families of those raising children with disabilities: Study protocol for a non-randomized waitlist-controlled trial

2021 ◽  
Author(s):  
Akemi Matsuzawa ◽  
Rie Wakimizu ◽  
Iori Sato ◽  
Hiroshi Fujioka ◽  
Kaori Nishigaki ◽  
...  
Keyword(s):  
Children With Disabilities ◽  
Controlled Trial ◽  
Social Resources ◽  
Early Group ◽  
Post Intervention ◽  
Intervention Evaluation ◽  
Raising Children ◽  
Family Empowerment ◽  
Evaluation Time ◽  
Delayed Group

Abstract BackgroundFamilies raising children with disabilities assume risks to their health and lives. Therefore, it is necessary to support these families to improve family empowerment, which is the ability of these families to control their own lives and to promote the collaborative raising of children with disabilities. This is the first online program development and interventional study focusing on the empowerment of families raising children with disabilities who live at home in Japan.MethodThe program consisted of four online peer-based group sessions. Moreover, the families engage in several activities in stages wherein they discover their own issues, find measures to resolve them, and take action, while visualizing interfamily relationships, including social resources, and the status of their family life, with facilitators and other peer members. This study was a non-randomized, waitlist-controlled trial. It compared the results of the intervention group (early group) and the waitlist-controlled group (delayed group). The participants were allocated to the early or delayed group in the order of their applications. The main outcome was family empowerment. Other outcomes are the caregiver burden, awareness of the use of social resources, self-compassion, and the quality of life (QOL) of primary caregivers. The timing of the online surveys was as follows: the initial evaluation (Time 1 [T1]) was conducted before the start of the first early group program, and post-intervention evaluation (Time 2 [T2]) was conducted immediately (within one week) after the early group had completed all four sessions (four weeks) of the program. Follow-up evaluation (Time 3 [T3]) was conducted four weeks after the post-intervention evaluation. This timing was the same in the delayed group, but the delayed group attended the program after a four-week waiting period, compared to the early group.DiscussionThe intention is to evaluate whether the provision of the program developed in this study and the evaluation test design are feasible and to verify the efficacy of this program.Clinical trial registrationThe UMIN Clinical Trials Registry (UMIN000044172), registration date: May 19, 2021. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050422

Family caregiver grief and depression outcomes from the ENABLE III randomized controlled trial.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 48-48
Author(s):  
J Nicholas Dionne-Odom ◽  
Andres Azuero ◽  
Kathleen Lyons ◽  
Jay Hull ◽  
Tor Tosteson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Advanced Cancer ◽  
Effect Size ◽  
Controlled Trial ◽  
Group Effect ◽  
Early Group ◽  
Randomized Controlled ◽  
Care Recipients ◽  
After Care ◽  
Delayed Group

48 Background: Little is known whether early palliative care (PC) support for family caregivers (FCGs) impacts grief and depression after care recipients die. We conducted a randomized controlled trial (RCT) of a nurse-led, phone-based concurrent PC intervention for FCGs delivered at the time of care recipients’ advanced cancer diagnosis (early group) or 12 weeks later (delayed group). We hypothesized that grief and depression scores would be lower for early compared to delayed group FCGs. Methods: Early vs. delayed RCT (10/2010-9/2013) of 123 FCGs of community dwelling persons with advanced cancer in a rural, New Hampshire NCI-designated comprehensive cancer center and affiliated outreach clinics and a Vermont VA medical center receiving a multicomponent intervention (ENABLE [Educate, Nurture, Advise, Before Life Ends]) consisting of 3 weekly sessions, monthly follow-up, and a bereavement call. FCGs of persons dying during the study period completed the Center for Epidemiological Study-Depression scale (CESD) and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients’ deaths. Generalized estimating equations were used to compute group means, standard deviations, and between-group effect size differences. Results: For care recipients who died (n = 70), 44 FCGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depression scores (CESD) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Between-group effect size differences were not statistically significant (CESD: d = -.27, p = .38; PG13: d = -.36, p = .24). Conclusions: Though statistically insignificant, the magnitude of the observed between-group differences for depression was small and for grief was medium. Considering the small sample size and the delayed group’s mean depression score surpassing the clinical cutoff (CESD score > 16), the clinical relevance of these findings cannot be ruled out. Future upstream FCG PC interventions initiated long before end of life should continue to examine intervention effects on FCG after-death outcomes. Clinical trial information: NCT01245621.

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 EXPRESS: Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach

2021 ◽  
pp. 174749302110176
Author(s):  
Brodie M Sakakibara ◽  
Scott A Lear ◽  
Susan I Barr ◽  
Charles Goldsmith ◽  
Amy Schneeberg ◽  
...  
Keyword(s):  
Risk Factors ◽  
Controlled Trial ◽  
Cognitive Status ◽  
Self Management ◽  
Community Living ◽  
Memory Training ◽  
Stroke Survivors ◽  
Post Intervention ◽  
Lifestyle Behaviour ◽  
Mild Stroke

Background: Stroke Coach is a lifestyle coaching telehealth program to improve self-management of stroke risk factors. Aims: To examine the efficacy of Stroke Coach on lifestyle behaviour and risk factor control among community-living stroke survivors within one-year post stroke. Methods: Participants were randomized to Stroke Coach or an attention control Memory Training group. Lifestyle behaviour was measured using the Health Promoting Lifestyle Profile II. Secondary outcomes included specific behavioural and cardiometabolic risk factors, health-related quality of life (HRQoL), cognitive status, and depressive symptoms. Measurements were taken at baseline, post-intervention (6 months), and retention (12 month). Linear mixed-effects models were used to test the study hypotheses (p<0.05). All analyses were intention-to-treat. Results: The mean age of the Stroke Coach (n=64) and Memory Training (n=62) groups was 67.2 and 69.1 years, respectively. The majority of participants (n = 100) had mild stroke (modified Rankin Scale = 1 or 2), were active, with controlled blood pressure (mean = 129/79 mmHg) at baseline. At post-intervention, there were no significant differences in lifestyle (b = -2.87; 95%CI -8.03 to 2.29; p=0.28). Glucose control, as measured by HbA1c (b = 0.17; 95%CI 0.17 to 0.32; p=0.03), and HRQoL, measured using SF-36 Physical Component Summary (b = -3.05; 95%CI -5.88 to -0.21; p=0.04), were significantly improved in Stroke Coach compared to Memory Training, and the improvements were maintained at retention. Conclusion: Stroke Coach did not improve lifestyle behaviour, however, there were improvements to HbA1c and HRQoL among community-living stroke survivors with mild stroke-related disability. (ClinicalTrials.gov identifier: NCT02207023)

scholarly journals A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 910
Author(s):  
Dorthe Djernis ◽  
Mia S. O’Toole ◽  
Lone O. Fjorback ◽  
Helle Svenningsen ◽  
Mimi Y. Mehlsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Effect Sizes ◽  
Medium Effect ◽  
Control Group ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Self Compassion ◽  
Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

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.

scholarly journals Impact of a behaviourally focused nutrition education intervention on attitudes and practices related to eating habits and activity levels in Indian adolescents

2021 ◽  
pp. 1-12
Author(s):  
Panchali Moitra ◽  
Jagmeet Madan ◽  
Preeti Verma
Keyword(s):  
Nutrition Education ◽  
Eating Habits ◽  
Vegetable Consumption ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Activity Levels ◽  
Post Intervention ◽  
Attitudes And Practices ◽  
Indian Adolescents

Abstract Objective: To evaluate the effectiveness of a behaviourally focused nutrition education (NE) intervention based on the Health Belief Model (HBM) to improve knowledge, attitudes and practices (KAP) related to eating habits and activity levels in 10–12-year-old adolescents in Mumbai, India. Design: School-based cluster randomised controlled trial. The experimental group (EG) received weekly NE and three parent sessions over 12 weeks; no sessions were conducted for the control group (CG). The theoretical framework of HBM and focus group discussion results guided the development of behaviour change communication strategies and NE aids. KAP were measured using a validated survey instrument, administered at baseline and endline in EG and CG. Paired and independent t tests determined within-group and between-group changes in pre–post scores. Setting: Two aided and two private schools that were randomly allocated to either an EG or CG. Participants: Adolescent boys and girls (n 498; EG n 292 and CG n 206). Results: EG reported improvements in mean knowledge (39·3%), attitude (7·3 %), diet (9·6 %) and activity practice (9·4%) scores from pre to post intervention. No significant changes were observed in CG. Significant improvements in scores associated with perceived benefits, barriers and self-efficacy, breakfast and vegetable consumption, and moderate-to-vigorous activities were observed in EG. Conclusions: Integrating NE into the academic curriculum and adopting evidence-based lessons that entail targeted information delivery and participatory activities can improve knowledge, foster right attitudes and facilitate better eating and activity-related practices in Indian adolescents.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

scholarly journals The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ben Young ◽  
Marie Kotzur ◽  
Lauren Gatting ◽  
Carissa Bonner ◽  
Julie Ayre ◽  
...  
Keyword(s):  
Online Survey ◽  
Controlled Trial ◽  
Significant Proportion ◽  
General Information ◽  
School Level ◽  
Text And Image ◽  
Post Intervention ◽  
Full Protocol ◽  
The Impact ◽  
Illness Coherence

Abstract Objectives Uptake of vaccination against COVID-19 is key to controlling the pandemic. However, a significant proportion of people report that they do not intend to have a vaccine, often because of concerns they have about vaccine side effects or safety. This study will assess the impact of theory-based messages on COVID-19 vaccination intention, drawing on the Necessity-Concerns framework to address previously reported beliefs and concerns about COVID-19 vaccination, and assess whether hypothesised variables (illness coherence, perceived necessity and concerns) mediate change in vaccination intention. Trial design Prospective, parallel two-arm, individually randomised (1:1) trial. Participants Adults aged over 18 years, living in Scotland and not vaccinated for COVID-19. A quota sampling approach will be used with the aim of achieving a nationally representative sample on gender, region and ethnic group, with oversampling of individuals with no educational qualifications or with only school-level qualifications. Intervention and comparator Intervention: Brief exposure to online text and image-based messages addressing necessity beliefs and concerns about COVID-19 vaccination. Comparator: Brief exposure to online text and image-based messages containing general information about COVID-19 and COVID-19 vaccination. Main outcomes Primary outcome: Self-reported intention to receive a vaccine for COVID-19 if invited, immediately post-intervention. Secondary outcomes: Self-reported COVID-19 illness coherence, perceived necessity of a COVID-19 vaccine and concerns about a COVID-19 vaccine, immediately post-intervention. Randomisation Quasi-randomisation performed automatically by online survey software, by creating a variable derived from the number of seconds in the minute that the participant initiates the survey. Participants starting the survey at 0-14 or 30-44 seconds in the minute are allocated to the intervention and 15-29 or 45-59 seconds to the comparator. Blinding (masking) Participants will not be blinded to group assignment but will not be informed of the purpose of the study until they have completed the follow-up survey. Investigators will be blinded to allocation as all procedures will be undertaken digitally and remotely without any investigator contact with participants. Numbers to be randomised (sample size) A total of 1,094 will be randomised 1:1 into two groups with 547 individuals in each. Trial Status Protocol version number 1.0, 26th February 2021. Recruitment status: Not yet recruiting, set to start April 2021 and end April 2021. Trial registration ClinicalTrials.gov, NCT04813770, 24th March 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

‘No one ever asked us’: a feasibility study assessing the co-creation of a physical activity programme with adolescent girls

2019 ◽  
Vol 27 (3) ◽  
pp. 34-43
Author(s):  
Méabh Corr ◽  
Elaine Murtagh
Keyword(s):  
Physical Activity ◽  
Data Collection ◽  
Behaviour Change ◽  
Adolescent Girls ◽  
Retention Rate ◽  
Controlled Trial ◽  
Activity Level ◽  
Health Concern ◽  
Post Intervention ◽  
Behaviour Change Wheel

Background: Globally, the poor activity level of adolescent girls is a public health concern. Little research has involved adolescents in the design of interventions. This study assessed the feasibility of involving girls in the co-creation of an activity programme. Methods: Thirty-one students (15–17 years old) were recruited from a post-primary school. The Behaviour Change Wheel guided intervention design, providing insights into participants’ capability, opportunity and motivation for change. Step counts and self-reported physical activity levels were recorded pre- and post-intervention. Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence. Results: Activity and educational sessions were delivered for six weeks during physical education class. Average attendance was 87% (benchmark = 80%). Eligibility was 61% (benchmark = 60%). There was a 100% retention rate (benchmark = 90%). All participants ( n = 31) completed baseline measures and 71% ( n = 22) completed post-measures. 54% ( n = 17) of students completed pedometer measurements, with 32% ( n = 10) having complete data. Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p > 0.05). Data collection was feasible, receiving a mean score > 4/5 (benchmark > 3.5/5). Conclusions: The Behaviour Change Wheel can be used to co-create an activity programme with adolescent girls. Predetermined benchmarks, except for pedometer recordings, were reached or exceeded, providing evidence for the need of a randomised controlled trial to test effectiveness.

scholarly journals A Pragmatic Controlled Trial of Forest Bathing Compared with Compassionate Mind Training in the UK: Impacts on Self-Reported Wellbeing and Heart Rate Variability

2021 ◽  
Vol 13 (3) ◽  
pp. 1380
Author(s):  
Kirsten McEwan ◽  
David Giles ◽  
Fiona J. Clarke ◽  
Yasu Kotera ◽  
Gary Evans ◽  
...  
Keyword(s):  
Heart Rate ◽  
Heart Rate Variability ◽  
Positive Emotions ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Increase Heart Rate ◽  
Future Research ◽  
Post Intervention ◽  
Forest Bathing ◽  
Mind Training

Forest Bathing, where individuals use mindfulness to engage with nature, has been reported to increase heart rate variability and benefit wellbeing. To date, most Forest Bathing studies have been conducted in Asia. Accordingly, this paper reports the first pragmatic controlled trial of Forest Bathing in the United Kingdom, comparing Forest Bathing with a control comprising an established wellbeing intervention also known to increase heart rate variability called Compassionate Mind Training. Sixty-one university staff and students (50 females, 11 males) were allocated to (i) Forest Bathing, (ii) Compassionate Mind Training or (iii) Forest Bathing combined with Compassionate Mind Training. Wellbeing and heart rate variability were measured at baseline, post-intervention and three-months follow-up. There were improvements in positive emotions, mood disturbance, rumination, nature connection and compassion and 57% of participants showed an increase in heart rate variability. There were no significant differences between conditions, showing that Forest Bathing had equivalence with an established wellbeing intervention. The findings will help healthcare providers and policy makers to understand the effects of Forest Bathing and implement it as a feasible social prescription to improve wellbeing. Future research needs to involve clinical populations and to assess the effects of Forest Bathing in a fully powered randomised controlled trial.

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