Dataset Information

A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial.

ABSTRACT:

Background

Mental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers-the Thrive program-has been newly developed to promote habits and activities that contribute to brain health and overall mental well-being.

Objective

This paper describes the protocol for a randomized controlled trial whose objective is to evaluate the Thrive program in comparison with an active control condition to measure whether the program is effective at increasing well-being and decreasing symptoms of psychological distress in health care workers at a designated Australian hospital.

Methods

The trial will comprise two groups (intervention vs active control) and 4 measurement occasions over a 12-week period. A survey will be administered in each of weeks 0, 4, 8, and 12, and the well-being program will be delivered in weeks 1-7 (via web-based video presentations or digital pamphlets). Each of the 4 surveys will comprise a range of questionnaires to measure well-being, psychological distress, and other key variables. The planned analyses will estimate group-by-time interaction effects to test the hypothesis that mental health will increase over time in the intervention condition relative to the active control condition.

Results

The Thrive program was delivered to a small number of wards at the hospital between February 2021 and July 2021, and it will be delivered to the remaining wards from October 2021 to December 2021. A power calculation has recommended a sample size of at least 200 participants in total. A linear mixed model will be used to estimate the interaction effects.

Conclusions

This trial seeks to evaluate a new web-based well-being program for health care workers at a major public hospital. It will contribute to the growing body of research on mental well-being and ways to promote it.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12621000027819; https://tinyurl.com/58wwjut9.

International registered report identifier (irrid)

DERR1-10.2196/34005.

SUBMITTER: Egan LA

PROVIDER: S-EPMC9073619 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial.

Egan Luke A LA Mulcahy Mary M Tuqiri Karen K Gatt Justine M JM

JMIR research protocols 20220421 4

<h4>Background</h4>Mental health has come to be understood as not merely the absence of mental illness but also the presence of mental well-being, and recent interventions have sought to increase well-being in various populations. A population that deserves particular attention is that of health care workers, whose occupations entail high levels of stress, especially given the ongoing COVID-19 pandemic. A neuroscience-based web-based well-being program for health care workers-the Thrive program- ...[more]

PMID: 35451973

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Project description:BackgroundNew parents face increased risks of emotional distress and relationship dissatisfaction. Digital interventions increase support access, but few preventive programs are optimized for both parents.ObjectiveThis study aims to conduct the first randomized controlled trial on universal self-guided digital programs to support positive perinatal adjustment of both mothers and fathers. Effects of childcare information (Baby Care) and information plus an interactive program (Baby Steps Wellbeing) were compared from the third trimester baseline to 3 and 6 months subsequently.MethodsThe study recruited 388 co-parenting male-female adult couples expecting their first single child (26-38 weeks' gestation), using web-based registration. Most (337/388, 86.8%) were obtained from prenatal hospital classes. Couples' randomization was automated and stratified by Edinburgh Postnatal Depression Scale (EPDS) scores (50% couples scored high if either mother >7, father >5). All assessments were web-based self-reports: the EPDS and psychosocial quality of life were primary outcomes; relationship satisfaction, social support, and self-efficacy for parenting and support provision were secondary. Linear mixed models provided intention-to-treat analyses, with linear and quadratic effects for time and random intercepts for participants and couples.ResultsSelection criteria were met by 63.9% (248/388) of couples, who were all randomized. Most participants were married (400/496, 80.6%), tertiary educated (324/496, 65.3%), employed full time (407/496, 82%), and born in Australia (337/496, 67.9%). Their mean age was 32.2 years, and average gestation was 30.8 weeks. Using an EPDS cutoff score of 13, 6.9% (18/248) of men, and 16.1% (40/248) of women screened positive for depression at some time during the 6 months. Retention of both partners was 80.6% (201/248) at the 6-month assessments, and satisfaction with both programs was strong (92% ≥50). Only 37.3% (185/496) of participants accessed their program more than once, with higher rates for mothers (133/248, 53.6%) than fathers (52/248, 20.9%; P<.001). The EPDS, quality of life, and social support did not show differential improvements between programs, but Baby Steps Wellbeing gave a greater linear increase in self-efficacy for support provision (P=.01; Cohen d=0.26) and lower reduction in relationship satisfaction (P=.03; Cohen d=0.20) than Baby Care alone. Mothers had greater linear benefits in parenting self-efficacy over time than fathers after receiving Baby Steps Wellbeing rather than Baby Care (P=.01; Cohen d=0.51). However, the inclusion of program type in analyses on parenting self-efficacy and relationship satisfaction did not improve model fit above analyses with only parent gender and time.ConclusionsThree secondary outcomes showed differential benefits from Baby Steps Wellbeing, but for one (parenting self-efficacy), the effect only occurred for mothers, perhaps reflecting their greater program use. Increased engagement will be needed for more definitive testing of the potential benefits of Baby StepsWellbeing for perinatal adjustment.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001256662; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367277.

Project description:BackgroundResilience is a protective factor in healthy aging, helping to maintain and recover physical and mental functions. The Resilience in Illness Model has proven effective in fostering resilience and well-being. Physical activity is crucial for older adults' independence and well-being, even as aging causes a progressive decline. Additionally, older adults face challenges such as spousal loss and physical disability, making preventive intervention strategies necessary.ObjectiveThis study aims to develop and evaluate a web-based program to enhance resilience, physical activity, and well-being among community-dwelling older adults. Additionally, we aim to gather feedback on the program's strengths and limitations.MethodsA 4-week resilience-enhancing program was created, incorporating role-play and talk-in-interaction and focusing on 3 key skills: coping, control belief, and manageability. The program included scenarios such as becoming widowed and suffering a stroke, designed to engage older adults. A pilot test preceded the intervention. As a result of the COVID-19 pandemic, the program shifted from in-person to web-based sessions. A single-blind, parallel-group, randomized controlled trial was conducted. Participants aged over 65 years were recruited offline and randomly assigned to either an intervention or control group. A certified resilience practitioner delivered the program. Outcomes in resilience, physical activity, and well-being were self-assessed at baseline (T0), 4 weeks (T1), and 12 weeks (T2) after the program. A mixed methods approach was used to evaluate feedback.ResultsA web-based participatory program enhancing 3 skills-coping, control belief, and manageability for resilience-was well developed. Among 96 participants, 63 were randomized into the intervention group (n=31) and the control group (n=32). The mean age in the intervention group was 69.27 (SD 3.08) years and 74.84 (SD 6.23) years in the control group. Significant between-group differences at baseline were found in age (t45.6=-4.53, P<.001) and physical activity at baseline (t61=2.92, P=.005). No statistically significant between-group differences over time were observed in resilience (SE 7.49, 95% CI -10.74 to 18.61, P=.60), physical activity (SE 15.18, 95% CI -24.74 to 34.74, P=.74), and well-being (SE 3.74, 95% CI -2.68 to 11.98, P=.21) after controlling for baseline differences. The dropout rate was lower in the intervention group (2/31, 6%) compared with the control group (5/32, 16%). Moreover, 77% (24/31) of participants in the intervention group completed the entire program. Program feedback from the participants indicated high satisfaction with the web-based format and mentorship support.ConclusionsThis study demonstrated that a web-based resilience-enhancing program is appropriate, acceptable, feasible, and engaging for community-dwelling older adults. The program garnered enthusiasm for its potential to optimize resilience, physical activity, and well-being, with mentorship playing a crucial role in its success. Future studies should aim to refine program content, engagement, and delivery methods to effectively promote healthy aging in this population.Trial registrationClinicalTrials.gov NCT05808491; https://clinicaltrials.gov/ct2/show/NCT05808491.

Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:BACKGROUND:Emotional exhaustion (EE) in health care workers is common and consequentially linked to lower quality of care. Effective interventions to address EE are urgently needed. OBJECTIVE:This randomized single-exposure trial examined the efficacy of a gratitude letter-writing intervention for improving health care workers' well-being. METHODS:A total of 1575 health care workers were randomly assigned to one of two gratitude letter-writing prompts (self- vs other focused) to assess differential efficacy. Assessments of EE, subjective happiness, work-life balance, and tool engagement were collected at baseline and 1-week post intervention. Participants received their EE score at baseline and quartile benchmarking scores. Paired-samples t tests, independent t tests, and correlations explored the efficacy of the intervention. Linguistic Inquiry and Word Count software assessed the linguistic content of the gratitude letters and associations with well-being. RESULTS:Participants in both conditions showed significant improvements in EE, happiness, and work-life balance between the intervention and 1-week follow-up (P<.001). The self-focused (vs other) instruction conditions did not differentially predict improvement in any of the measures (P=.91). Tool engagement was high, and participants reporting higher motivation to improve their EE had higher EE at baseline (P<.001) and were more likely to improve EE a week later (P=.03). Linguistic analyses revealed that participants high on EE at baseline used more negative emotion words in their letters (P=.005). Reduction in EE at the 1-week follow-up was predicted at the level of a trend by using fewer first-person (P=.06) and positive emotion words (P=.09). No baseline differences were found between those who completed the follow-up assessment and those who did not (Ps>.05). CONCLUSIONS:This single-exposure gratitude letter-writing intervention appears to be a promising low-cost, brief, and meaningful tool to improve the well-being of health care workers.

Project description:BackgroundMental health issues among emerging adults (aged 19-25 years) on a global scale have underscored the need to address their widespread experiences of depression and anxiety. As a result of the COVID-19 pandemic, emerging studies are being directed toward the development and deployment of digital peer emotional disclosure and support for the psychological well-being of emerging adults. However, it is important to explore the implementation and clinical effectiveness, as well as associated mechanisms of change, for optimal approaches in conducting digital peer support interventions for emerging adults' psychological well-being.ObjectiveWe describe a randomized controlled trial to evaluate the implementation and clinical effectiveness of Acceset, a digital peer support intervention to address emerging adult mental well-being. The intervention has 2 components. First, the digital peer support training equips befrienders (ie, peers who provide support) to harness 4 components of psychological well-being-mattering, selfhood, compassion, and mindfulness-to provide effective peer support for seekers (ie, peers who seek support). Second, Acceset incorporates psychological well-being digital markers and harnesses community engagement to drive emotional disclosure among peers.MethodsA total of 100 participants (aged 19-25 years) from the National University of Singapore will be recruited and randomized into 2 arms. In arm 1 (n=50), the seekers will use Acceset with befrienders (n=30) as well as moderators (n=30) for 3 weeks. Arm 2 comprises a wait-listed control group (n=50). A questionnaire battery will be used to monitor seekers and befrienders at 4 time points. These include baseline (before the intervention), 3 weeks (end of the intervention), and 6 and 9 weeks (carryover effect measurement). Implementation outcomes of the intervention will involve evaluation of the training curriculum with respect to adoption and fidelity as well as user acceptability of the Acceset platform and its feasibility for broader deployment. Clinical outcomes will include mattering, selfhood, compassion, mindfulness, perceived social support, and psychological well-being scores.ResultsThis protocol received National University of Singapore Institutional Ethics Review Board approval in October 2021. Recruitment will commence in January 2022. We expect data collection and analyses to be completed in June 2022. Preliminary findings are expected to be published in December 2022. The Cohen d index will be used for effect size estimation with a .05 (95% reliability) significance level and 80% power.ConclusionsThis protocol considers a novel digital peer support intervention-Acceset-that incorporates components and digital markers of emerging adult mental well-being. Through the validation of the Acceset intervention, this study defines the parameters and conditions for digital peer support interventions for emerging adults.Trial registrationClinicalTrials.gov NCT05083676; https://clinicaltrials.gov/ct2/show/NCT05083676.International registered report identifier (irrid)PRR1-10.2196/34602.

Project description:IntroductionStress at work and psychosocial risks are a major public health problem. Sophrology and neurolinguistic programming (NLP) have demonstrated benefits in terms of mental, physical and social health, both in the general population and in patients, and both in and out of hospital settings. However, these approaches have never been provided at the hospital for the benefit of health professionals at risk of suffering at work. In general, we aim to demonstrate the effectiveness of a hospital sophrology/NLP intervention for health care professionals at risk of stress-related disorders. The secondary objectives are to study (i) within-group, and (ii) between-group): (1) effects on mental, physical, and social health; (2) persistence of effect; (3) relationships between job perception and mental, physical, and social health; (4) intervention success factors (personality and job perception, attendance and practice, other); (5) effects on other stress biomarkers (other measures of autonomic nervous system activity, DHEAS, cortisol, etc.).MethodsOur study will be a randomized controlled prospective study (research involving the human person of type 2). The study will be proposed to any health-care workers (HCW) or any non-HCW (NHCW) from a healthcare institution (such as CHU of Clermont-Ferrand, other hospitals, clinics, retirement homes). Participants will benefit from NLP and sophrology interventions at the hospital. For both groups: (i) heart rate variability, skin conductance and saliva biomarkers will be assessed once a week during the intervention period (6 to 8 sophrology sessions) and once by month for the rest of the time; (ii) the short questionnaire will be collected once a week during the whole protocol (1-2 min); (iii) the long questionnaire will be assessed only 5 times: at baseline (M0), month 1 (M1), month 3 (M3), month 5 (M5) and end of the protocol (M7).Ethics and disseminationThe protocol, information and consent form had received the favorable opinion from the Ethics Committee. Notification of the approval of the Ethics Committee was sent to the study sponsor and the competent authority (ANSM). The study is registered in ClinicalTrials.gov under the identification number NCT05425511 after the French Ethics Committee's approval. The results will be reported according to the CONSORT guidelines.Strengths and limitations of this studyThe psychological questionnaires in this study are self-assessed. It is also possible that responses suffer from variation. For the study, participants need to attend 6 to 8 sophrology sessions and one visit per month for 7 months, which might seem demanding. Therefore, to make sure that participants will complete the protocol, two persons will be fully in charge of the participants' follow-up.

Project description:BackgroundMindfulness can improve overall well-being by training individuals to focus on the present moment without judging their thoughts. However, it is unknown how much mindfulness practice and training are necessary to improve well-being.ObjectiveThe primary aim of this study was to determine whether a standard 8-session web-based mindfulness-based cognitive therapy (MBCT) program, compared with a brief 3-session mindfulness intervention, improved overall participant well-being. In addition, we sought to explore whether the treatment effects differed based on the baseline characteristics of the participants (ie, moderators).MethodsParticipants were recruited from 17 patient-powered research networks, web-based communities of stakeholders interested in a common research area. Participants were randomized to either a standard 8-session MBCT or a brief 3-session mindfulness training intervention accessed on the web. The participants were followed for 12 weeks. The primary outcome of the study was well-being, as measured by the World Health Organization-Five Well-Being Index. We hypothesized that MBCT would be superior to a brief mindfulness training.ResultsWe randomized 4411 participants, 3873 (87.80%) of whom were White and 3547 (80.41%) of female sex assigned at birth. The mean baseline World Health Organization-Five Well-Being Index score was 50.3 (SD 20.7). The average self-reported well-being in each group increased over the intervention period (baseline to 8 weeks; model-based slope for the MBCT group: 0.78, 95% CI 0.63-0.93, and brief mindfulness group: 0.76, 95% CI 0.60-0.91) as well as the full study period (ie, intervention plus follow-up; baseline to 20 weeks; model-based slope for MBCT group: 0.41, 95% CI 0.34-0.48; and brief mindfulness group: 0.33, 95% CI 0.26-0.40). Changes in self-reported well-being were not significantly different between MBCT and brief mindfulness during the intervention period (model-based difference in slopes: -0.02, 95% CI -0.24 to 0.19; P=.80) or during the intervention period plus 12-week follow-up (-0.08, 95% CI -0.18 to 0.02; P=.10). During the intervention period, younger participants (P=.05) and participants who completed a higher percentage of intervention sessions (P=.005) experienced greater improvements in well-being across both interventions, with effects that were stronger for participants in the MBCT condition. Attrition was high (ie, 2142/4411, 48.56%), which is an important limitation of this study.ConclusionsStandard MBCT improved well-being but was not superior to a brief mindfulness intervention. This finding suggests that shorter mindfulness programs could yield important benefits across the general population of individuals with various medical conditions. Younger people and participants who completed more intervention sessions reported greater improvements in well-being, an effect that was more pronounced for participants in the MBCT condition. This finding suggests that standard MBCT may be a better choice for younger people as well as treatment-adherent individuals.Trial registrationClinicalTrials.gov NCT03844321; https://clinicaltrials.gov/ct2/show/NCT03844321.

Project description:BackgroundPromoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother's health and well-being, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation).ObjectiveThe primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD values for the outcome measures to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions.MethodsPregnant women (n=75) participating in a longitudinal birth cohort study (the ORIGINS project) will be recruited to this study from 18 weeks of gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies and the participants' engagement and adherence to the interventions. We will also assess the experiences of women in each of the 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews.ResultsThis project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.ConclusionsIf the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women.Trial registrationAustralian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx.International registered report identifier (irrid)PRR1-10.2196/19803.

Project description:BackgroundA growing body of evidence suggests that early life health and developmental outcomes can be improved through parental support programs. The objective of this project was to test the feasibility, impact, and relative cost-effectiveness of an adapted "Reach Up and Learn" program delivered through home-visiting programs as well as through center-based parenting groups on child health and development in the municipality of Boa Vista, Brazil.MethodsA randomized, stepped-wedge design was used to roll out and evaluate the two parenting platforms in Boa Vista municipality. A total of 39 neighborhoods with a high Neighborhood Vulnerability Index were selected for the study. For the first phase of the program, nine neighborhoods were randomly selected for home visits, and two were randomly selected for the center-based parenting groups. In the second phase of the program, 10 neighborhoods were added to the home-visiting program, and eight were added to the center-based program. In the final phase of the program, the remaining 10 control areas will also be assigned to treatment. Study eligibility will be assessed through a baseline survey completed by all pregnant women in the 39 study areas. Pregnant women will be eligible to participate in the study if they are either classified as poor, were under age 20 years when they became pregnant, or if they indicate to have been exposed to domestic or sexual violence. To assess program impact, an endline survey will be conducted when children reach age 2 years. The primary study outcome is child development at age 2 years as measured by the PRIDI instrument. Secondary outcome will be infant mortality, which will be assessed linking municipal vital registration systems to the program rollout.DiscussionThis trial will assess the feasibility and impact of parenting programs rolled out at medium scale. The results from the trial should create evidence urgently needed for guiding Brazil's national Criança Feliz program as well as similar efforts in other countries.Trial registrationClinicalTrials.gov, ID: NCT03386747. Registered on 13 December 2017. All items of the World Health Organization Trial Registration Data Set are available in this record.

Dataset Information

A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

A Web-Based Well-being Program for Health Care Workers (Thrive): Protocol for a Randomized Controlled Trial.

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