scholarly journals A pragmatic randomized wait-list controlled trial of a smartphone-based well-being training in public school system employees during the COVID-19 pandemic

2021 ◽  
Author(s):  
Matthew James Hirshberg ◽  
Corrina Frye ◽  
Cortland J. Dahl ◽  
Kevin M Riordan ◽  
Nate Vack ◽  
...  
Keyword(s):  
Mental Health ◽  
Public School ◽  
School System ◽  
Controlled Trial ◽  
Well Being ◽  
Vital Role ◽  
Public School System ◽  
Wait List ◽  
Post Intervention ◽  
Secondary Outcomes

While the extraordinary pressures of the COVID-19 pandemic on student mental health have received considerable attention, less attention has been placed on the well-being of school system employees despite their vital role in society and the education of young people. The need for innovative mental health promotion strategies that are acceptable, accessible, and scalable has never been more evident. In a remote pragmatic randomized wait-list controlled trial of Wisconsin public school system employees (N=662) during the COVID-19 pandemic, we investigate a candidate program: a freely available four-week smartphone-based meditation app designed to train key constituents of well-being (Healthy Minds Program; HMP). Following our preregistered analysis plan and consistent with hypotheses, assignment to the HMP predicted significantly larger reductions in psychological distress, our primary outcome, at post-intervention (standardized mean difference (SMD)=-0.52 95% CI [-0.68 to -0.37], P<0.0001) and at the three-month follow-up (SMD=-0.33 [-0.48 to -0.18], P<0.001). Also consistent with hypotheses, similar indications of immediate and sustained benefit following the HMP were observed on all six preregistered secondary outcomes selected to tap skills targeted in the app (absolute value SMDs=0.19 to 0.42, all Ps<0.031 corrected). Secondary outcomes included an antecedent to anxiety and depression (perseverative thinking) and a measure of loneliness. We found no evidence for elevated adverse effects in the HMP group and the HMP was at least as effective in subsample analyses involving participants with elevated anxiety and depressive symptoms at baseline. These data suggest that the HMP has promise as an acceptable, accessible, and scalable mental health intervention.

scholarly journals WHO Parents Skills Training (PST) programme for children with developmental disorders and delays delivered by Family Volunteers in rural Pakistan: study protocol for effectiveness implementation hybrid cluster randomized controlled trial

2017 ◽  
Vol 4 ◽  
Author(s):  
S. U. Hamdani ◽  
P. Akhtar ◽  
Zill-e-Huma ◽  
H. Nazir ◽  
F. A. Minhas ◽  
...  
Keyword(s):  
Mental Health ◽  
Developmental Disorders ◽  
Controlled Trial ◽  
Public Mental Health ◽  
Skills Training ◽  
Well Being ◽  
Evidence Based ◽  
Post Intervention ◽  
Hybrid Cluster ◽  
Rural Pakistan

Background.Development disorders and delays are recognised as a public health priority and included in the WHO mental health gap action programme (mhGAP). Parents Skills Training (PST) is recommended as a key intervention for such conditions under the WHO mhGAP intervention guide. However, sustainable and scalable delivery of such evidence based interventions remains a challenge. This study aims to evaluate the effectiveness and scaled-up implementation of locally adapted WHO PST programme delivered by family volunteers in rural Pakistan.Methods.The study is a two arm single-blind effectiveness implementation-hybrid cluster randomised controlled trial. WHO PST programme will be delivered by ‘family volunteers’ to the caregivers of children with developmental disorders and delays in community-based settings. The intervention consists of the WHO PST along with the WHO mhGAP intervention for developmental disorders adapted for delivery using the android application on a tablet device. A total of 540 parent-child dyads will be recruited from 30 clusters. The primary outcome is child's functioning, measured by WHO Disability Assessment Schedule – child version (WHODAS-Child) at 6 months post intervention. Secondary outcomes include children's social communication and joint engagement with their caregiver, social emotional well-being, parental health related quality of life, family empowerment and stigmatizing experiences. Mixed method will be used to collect data on implementation outcomes. Trial has been retrospectively registered at ClinicalTrials.gov (NCT02792894).Discussion.This study addresses implementation challenges in the real world by incorporating evidence-based intervention strategies with social, technological and business innovations. If proven effective, the study will contribute to scaled-up implementation of evidence-based packages for public mental health in low resource settings.Trial registration.Registered with ClinicalTrials.gov as Family Networks (FaNs) for Children with Developmental Disorders and Delays. Identifier: NCT02792894 Registered on 6 July 2016.

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

10.2196/24264 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24264
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

Benefit-Finding Intervention Delivered Individually to Alzheimer Family Caregivers: Longer-Term Outcomes of a Randomized Double-Blind Controlled Trial

2019 ◽  
Vol 75 (9) ◽  
pp. 1884-1893 ◽  
Author(s):  
Sheung-Tak Cheng ◽  
Emily P M Mak ◽  
Timothy Kwok ◽  
Helene Fung ◽  
Linda C W Lam
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Benefit Finding ◽  
Post Intervention ◽  
Double Blind ◽  
Interaction Terms ◽  
Positive Aspects Of Caregiving ◽  
Secondary Outcomes

Abstract Objectives To examine the longer-term effects of benefit-finding on caregivers’ depressive symptoms (primary outcome), and global burden, role overload, psychological well-being, and positive aspects of caregiving (secondary outcomes). Method Ninety-six Hong Kong Chinese caregivers of relatives with Alzheimer’s disease were randomly assigned to receive the benefit-finding intervention (BFT) or one of the two control conditions, namely, simplified psychoeducation (lectures only; SIM-PE) or standard psychoeducation (STD-PE). Caregivers received four biweekly one-to-one interventions of 3 hours each at their own homes. We focused on outcomes measured at 4- and 10-month follow-ups. The trajectories of intervention effects were modeled by BFT × time and BFT × time2 interaction terms. Results Mixed-effects regression showed significant BFT × time2 interaction effects on depressive symptoms against both control conditions, suggesting diminishing BFT effects over time. Z tests showed that, compared with controls, BFT participants reported substantial reductions in depressive symptoms at 4-month follow-up (d = −0.85 and −0.75 vs. SIM-PE and STD-PE, respectively). For depressive symptoms measured at 10-month follow-up, BFT was indistinguishable from STD-PE, whereas a moderate effect was observed in comparison with SIM-PE (d = −0.52). Moreover, positive aspects of caregiving, but not other secondary outcomes, continued to show intervention effect up to 10-month follow-up. Discussion Benefit-finding is an efficacious intervention for depressive symptoms in Alzheimer caregivers, with strong effects in the medium-term post-intervention and possible moderate effects in the longer-term post-intervention.

scholarly journals Online single-session interventions for Kenyan adolescents: study protocol for a comparative effectiveness randomised controlled trial

2021 ◽  
Vol 34 (3) ◽  
pp. e100446
Author(s):  
Akash R Wasil ◽  
Tom Lee Osborn ◽  
John R Weisz ◽  
Robert J DeRubeis
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Comparative Effectiveness ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Single Session ◽  
Post Intervention ◽  
Digital Interventions ◽  
Randomised Controlled

BackgroundMental health problems are the leading cause of disability among adolescents worldwide, yet access to treatment is limited. Brief digital interventions have been shown to improve youth mental health, but little is known about which digital interventions are most effective.AimsTo evaluate the effectiveness of two digital single-session interventions (Shamiri-Digital and Digital-CBT (cognitive-behavioural therapy)) among Kenyan adolescents.MethodsWe will perform a school-based comparative effectiveness randomised controlled trial. Approximately 926 Kenyan adolescents will be randomly assigned to one of three conditions: Shamiri-Digital (focused on gratitude, growth mindsets and values), Digital-CBT (focused on behavioural activation, cognitive restructuring and problem solving) or a study-skills control condition (focused on note-taking and essay writing skills). The primary outcomes include depressive symptoms (measured by the Patient Health Questionnaire-8), anxiety symptoms (Generalized Anxiety Disorder Screener-7) and subjective well-being (Short Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes include acceptability, appropriateness, primary control and secondary control. Acceptability and appropriateness will be measured immediately post-intervention; other outcomes will be measured 2 weeks, 4 weeks and 12 weeks post-intervention.ResultsWe hypothesise that adolescents assigned to Shamiri-Digital and adolescents assigned to Digital-CBT will experience greater improvements (assessed via hierarchical linear models) than those assigned to the control group. We will also compare Shamiri-Digital with Digital-CBT, although we do not have a preplanned hypothesis.ConclusionsOur findings will help us evaluate two digital single-session interventions with different theoretical foundations. If effective, such interventions could be disseminated to reduce the public health burden of common mental health problems.Trial registration numberPACTR202011691886690.

PRELIMINARY REPORT OF A CONTROLLED MENTAL HEALTH WORKSHOP IN A PUBLIC SCHOOL SYSTEM

1955 ◽  
Vol 112 (3) ◽  
pp. 199-205 ◽  
Author(s):  
BENJAMIN H. BALSER ◽  
FRED BROWN ◽  
MINERVA L. BROWN ◽  
EDWARD D. JOSEPH ◽  
DONALD K. PHILLIPS
Keyword(s):  
Mental Health ◽  
Public School ◽  
School System ◽  
Preliminary Report ◽  
Public School System

scholarly journals Brief self-affirmation intervention for adults with psoriasis for reducing anxiety and depression and boosting well-being: Evidence from a randomized controlled trial

2021 ◽  
pp. 1-11
Author(s):  
Patryk Łakuta
Keyword(s):  
Mental Health ◽  
Health Outcomes ◽  
Active Control ◽  
Implementation Intentions ◽  
Controlled Trial ◽  
Well Being ◽  
Mental Health Outcomes ◽  
Control Group ◽  
Post Intervention

Abstract Background There are relatively few studies to address mental health implications of self-affirming, especially across groups experiencing a chronic health condition. In this study, short- and longer-term effects of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions; S-AII) were evaluated against an active control group (non-affirming implementation intentions; N-AII), matched to the target condition, and mere goal intention condition (a non-active control) in adults with psoriasis. The three pre-registered primary outcomes captured depression, anxiety, and well-being. Methods Adults with psoriasis (N = 175; Mage = 36.53, s.d. = 11.52) were randomized into S-AII, N-AII, or control. Participants' mental health outcomes were assessed prior to randomization (at baseline), at week 2 (post-intervention), and at a 1-month follow-up. Results Linear mixed models were used and results were reported on the intention-to-treat principle. Analyses revealed that S-AII exerted significantly more improvement in the course of well-being (ds > 0.25), depressive symptoms (ds > −0.40), and anxiety (ds > −0.45) than the N-AII and control group at 2-week post-intervention. Though the differences between groups faded at 1-month follow-up, the within-group changes over time for S-AII in all mental health outcomes remained significant. Conclusions Brief and low-intensity S-AII intervention exerted in the short-term a considerable impact on mental health outcomes. The S-AII shows promising results as a relevant public mental health strategy for enhancing well-being and reducing psychological distress. Future studies could consider whether these effects can be further enhanced with booster interventions.

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

BACKGROUND During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. OBJECTIVE We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. METHODS Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. RESULTS All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. CONCLUSIONS This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. CLINICALTRIAL ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24264

Sign in / Sign up

Export Citation Format

Share Document