scholarly journals Effect of a Mobile-based Intervention on Mental Health in Frontline Healthcare Workers Against COVID-19: Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Maria J. Serrano-Ripoll ◽  
Ignacio Ricci-Cabello ◽  
Rafael Jiménez ◽  
Rocío Zamanillo-Campos ◽  
Aina M. Yañez Juan ◽  
...  
Keyword(s):  
Mental Health ◽  
Mobile Health ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Interventions ◽  
Control Group ◽  
The Impact ◽  
To Receive ◽  
Trial Participants

ABSTRACTAimTo evaluate the impact of a psychoeducational, mobile health intervention based on cognitive behavioural therapy and mindfulness-based approaches on the mental health of healthcare workers at the frontline against COVID-19 in Spain.DesignWe will carry out a two-week, individually randomised, parallel group, controlled trial. Participants will be individually randomised to receive the PsyCovidApp intervention or control App intervention.MethodsThe PsyCovidApp intervention will include five modules: emotional skills, lifestyle behaviour, work stress and burnout, social support, and practical tools. Healthcare workers having attended COVID-19 patients will be randomized to receive the PsyCovidApp intervention (intervention group) or a control App intervention (control group). A total of 440 healthcare workers will be necessary to assure statistical power. Measures will be collected telephonically by a team of psychologists at baseline and immediately after the two weeks intervention period. Measures will include stress, depression and anxiety (DASS-21 questionnaire – primary endpoint), insomnia (ISI), burnout (MBI-HSS), post-traumatic stress disorder (DTS), and self-efficacy (GSE). The study was funded in May 2020, and was ethically approved in June 2020. Trial participants, outcome assessors and data analysts will be blinded to group allocation.DiscussionDespite the increasing use of mobile health interventions to deliver mental health care, this area of research is still on its infancy. This study will help increase the scientific evidence regarding the effectiveness of this type of intervention on this specific population and context.ImpactDespite the lack of solid evidence about their effectiveness, mobile-based health interventions are already being widely implemented because of their low cost and high scalability. The findings from this study will help health services and organizations to make informed decisions in relation to the development and implementation of this type of interventions, allowing them pondering not only their attractive implementability features, but also empirical data about its benefits.Clinical trial registrationNCT04393818 (ClinicalTrials.gov identifier)

scholarly journals The Effect of Physiotherapy Group Intervention in Reducing Pain Disorders and Mental Health Symptoms among Syrian Refugees: A Randomized Controlled Trial

2020 ◽  
Vol 17 (24) ◽  
pp. 9468
Author(s):  
Wegdan Hasha ◽  
Jannicke Igland ◽  
Lars T. Fadnes ◽  
Bernadette Kumar ◽  
Jasmin Haj-Younes ◽  
...  
Keyword(s):  
Mental Health ◽  
Chronic Pain ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Intervention Group ◽  
Complex Interventions ◽  
Control Group ◽  
Syrian Refugees ◽  
The Impact

Chronic pain is common among refugees, and often related to mental health problems. Its management, however, is often challenging. A randomized waitlist-controlled trial was designed to study the effect of group physiotherapy activity and awareness intervention (PAAI) on reducing pain disorders, and secondarily improving mental health, among Syrian refugees. A total of 101 adult Syrian refugees suffering from chronic pain were randomized to either the intervention group or the control group, which thereafter also received PAAI after a waiting period. Pain intensity measured by the Brief Pain Inventory (BPI) was the primary outcome. Scores from the Impact of Events Scale-Revised (IES-R 22) and the General Health Questionnaire (GHQ-12) were secondary outcomes. Intention-to-treat analyses (ITT) showed no effect of the intervention on either pain levels (regression coefficient [B {95% CI} of 0.03 {−0.91, 0.96}], IESR scores [4.8 {−3.7, 13.4}] or GHQ-12 scores [−0.4 {−3.1, 2.3}]). Yet, participants highly appreciated the intervention. Despite the negative findings, our study contributes to the evidence base necessary to plan targeted and effective health care services for refugees suffering from chronic pain and highlights the challenge of evaluating complex interventions adapted to a specific group.

scholarly journals Impacts of a Standing Desk Intervention within an English Primary School Classroom: A Pilot Controlled Trial

2020 ◽  
Vol 17 (19) ◽  
pp. 7048
Author(s):  
Aron P. Sherry ◽  
Natalie Pearson ◽  
Nicola D. Ridgers ◽  
William Johnson ◽  
Sally E. Barber ◽  
...  
Keyword(s):  
Mental Health ◽  
Primary School ◽  
Controlled Trial ◽  
School Setting ◽  
Intervention Group ◽  
Traditional Classroom ◽  
Control Group ◽  
Musculoskeletal Discomfort ◽  
Class Time ◽  
The Impact

Traditional classroom furniture dictates that children predominantly sit during class time. This study evaluated the impact of providing standing desks within a deprived UK primary school setting over 8 months using mixed-method approaches. All children within a Year 5 class (9–10-year-olds, n = 30) received an adjustable sit–stand desk, while another Year 5 class (n = 30) in a nearby school retained traditional furniture as a control classroom. At baseline, 4 months, and 8 months, activPAL monitors (PAL Technologies, Glasgow, UK) were worn for 7 days to provide time spent sitting and standing. Behavior-related mental health, musculoskeletal discomfort surveys, and a cognitive function test battery were also completed at all three timepoints. Intervention experiences from pupils and the teacher were captured using focus groups, interviews, and classroom observations. At both 4 months and 8 months, multi-level models revealed a reduction in class time sitting in the intervention group compared to the control group ((β (95%CI) 4 months −25.3% (−32.3, −18.4); 8 months −19.9% (−27.05, −12.9)). Qualitative data revealed challenges to teaching practicalities and a gradual decline in behavior-related mental health was observed (intervention vs. control: 4 months +5.31 (+2.55, +8.08); 8 months +7.92 (+5.18, +10.66)). Larger trials within similar high-priority settings are required to determine the feasibility and cost-effectiveness of providing standing desks to every child in the classroom.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

scholarly journals Assessing the impact of the European resilience curriculum in preschool, early and late primary school children

2021 ◽  
pp. 014303432110250
Author(s):  
Celeste Simões ◽  
Anabela C. Santos ◽  
Paula Lebre ◽  
João R. Daniel ◽  
Cátia Branquinho ◽  
...  
Keyword(s):  
Mental Health ◽  
Intervention Group ◽  
Well Being ◽  
Primary School Children ◽  
Control Group ◽  
Physical And Mental Health ◽  
Quasi Experimental ◽  
Mental Health Difficulties ◽  
Prosocial Behaviours ◽  
The Impact

Resilience is an individual’s ability to adapt successfully to and persevere during and after significant challenges. Resilience programmes based on a socioemotional learning approach have been associated with an increase in protextive factors (e.g., prosocial competencies), improvements in physical and mental health, and a decrease in internalised and externalised symptoms. The present study aimed to evaluate the impact of the RESCUR curriculum implemented in Portuguese schools on students’ academic, behavioural, and socioemotional outcomes, based on child and teacher reports. Participants included 1,084 children (53.2% male) aged 3-15 ( M = 7.24, SD = 2.31). A quasi-experimental study compared outcomes for an experimental intervention group (AIG) with a waiting list control group (WG). The results showed the RESCUR programme decreased mental health difficulties while increasing both prosocial behaviours and well-being. In addition, academic performance increased for those in preschool after implementation. Both teachers and children consistently reported positive behavioural changes in resilience-related competencies after implementing RESCUR. Our findings contribute to the recent research on the potential of RESCUR to address key socioemotional competencies and improve relevant protextive factors. Study limitations and future recommendations are addressed.

scholarly journals The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Alireza Amanollahi ◽  
Sheikh Mohammed Shriful Islam ◽  
Jenna McVicar ◽  
...  
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

scholarly journals Effect of Hope-oriented group counseling on mental health of infertile women with failed IVF cycles: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour
Keyword(s):  
Mental Health ◽  
Confidence Interval ◽  
Group Counseling ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mean Difference ◽  
Control Group ◽  
The Mean ◽  
And Control

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

scholarly journals The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Nicolaas P. Pronk ◽  
A. Lauren Crain ◽  
Jeffrey J. VanWormer ◽  
Brian C. Martinson ◽  
Jackie L. Boucher ◽  
...  
Keyword(s):  
Body Weight ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Study Groups ◽  
Outcome Variable ◽  
Control Group ◽  
Immediate Feedback ◽  
The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

scholarly journals The side effects of service changes: exploring the longitudinal impact of participation in a randomised controlled trial (DOORWAYS) on staff perceptions of barriers to change

2019 ◽  
Author(s):  
Caroline Laker ◽  
Matteo Cella ◽  
Felicity Callard ◽  
Til Wykes
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Occupational Status ◽  
Intervention Group ◽  
Direct Care ◽  
Care Staff ◽  
Control Group ◽  
Staff Perceptions ◽  
Barriers To Change ◽  
Randomised Controlled

Abstract Background Staff and service users have expressed concerns that service improvements in U.K. mental health wards have been slow or transient. It is possible that certain changes are positive for some (e.g. service users), but negative for others (e.g. staff), which may affect implementation success. In this study, we explore whether a programme of change to improve the therapeutic milieu on mental health wards influenced staff perceptions of barriers to change, 12 months after implementation. Method A cluster randomised controlled trial called DOORWAYS was conducted on eight inner-city U.K. acute mental health wards. Randomisation was achieved using a list randomly generated by a computer. A psychologist trained ward staff (mainly nurses) to deliver evidence-based groups and supported their initial implementation. The impact of these changes was measured over 12 months (when 4 wards were randomised), according to nurses’ perceptions of barriers to change (VOCALISE), using unstructured multivariate linear regression models. This innovative analysis method allows maximum use of data in randomised controlled trials with reduced sample sizes due to substantial drop out rates. The contextual influences of occupational status (staff) and of workplace setting (ward) were also considered. Results Staff who participated in the intervention had significantly worse perceptions of barriers to change at follow up. The perceptions of staff in the control group did not change over time. In both groups (N=120), direct care staff had more negative perceptions of barriers to change, and perceptions varied according to ward. Across time, direct care staff in the intervention group became more negative than those in the control group. Conclusion Participation in this program of change, worsened staff perceptions of barriers to change. In addition, occupational status (being from the direct care group) had a negative effect on perceptions of barriers to change, an effect that continued across time and was worse in the intervention group. Those providing direct care should be offered extra support when changes are introduced and through the implementation process. More effort should be placed around reducing the perceived burden of innovation for staff in mental health wards.

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