Brief digital interventions to support the psychological well-being of NHS staff during the COVID-19 pandemic: a three-arm pilot randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
Johannes De Kock ◽  
Helen Ann Latham ◽  
Richard G. Cowden ◽  
Breda Cullen ◽  
Katia Narzisi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Well Being ◽  
Rate Of Change ◽  
Mental Toughness ◽  
Psychological Interventions ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Health And Social Care ◽  
Randomised Controlled ◽  
Mental Well Being

BACKGROUND Health and social care staff are at high risk of experiencing adverse mental health outcomes during the COVID-19 pandemic. Hence, there is a need to prioritize and identify ways to effectively support their psychological wellbeing. Compared to traditional psychological interventions, digital psychological interventions are cost effective treatment options that allow for large-scale dissemination and transcend social distancing, overcome rurality, and minimize clinician time. OBJECTIVE This study reports outcomes of a CONSORT-compliant parallel-arm pilot randomised controlled trial (RCT) examining the potential usefulness of an existing and a novel digital psychological intervention aimed at supporting psychological health among NHS staff working through the COVID-19 pandemic. METHODS NHS Highland (NHSH) frontline staff volunteers (N = 169) were randomly assigned to the newly developed NHSH Staff Wellbeing Project (NHSWBP), an established digital intervention (My Possible Self; MPS), or to a waitlist (WL) condition for four weeks. Attempts were made to blind participants to which digital intervention they were allocated. The interventions were fully automated, without any human input or guidance. We measured five self-reported psychological outcomes over three time points: before (baseline), middle (after 2 weeks) and after treatment (4 weeks). The primary outcomes were anxiety (GAD-7), depression (PHQ-9) and mental well-being (Warwick-Edinburgh Mental Well-being Scale). The secondary outcomes included mental toughness (Mental Toughness Index) and gratitude (the Gratitude Questionnaire). RESULTS Retention rates at middle and post-intervention were 77% (n = 130) and 63.3% (n = 107), respectively. At post-intervention, small differences were noted between the WL condition and the two treatment conditions on anxiety (vs. MPS: d = .07, 95% CI: -.20, .33; vs. NHSWBP: d = .06, 95% CI: -.19, .31), depression (vs. MPS: d = .37, 95% CI: .07, .66; vs. NHSWBP: d = .18, 95% CI: -.11, .46), and mental well-being (vs. MPS: d = -.04, 95% CI: -.62, -.08; vs. NHSWBP: d = -.15, 95% CI: -.41, .10). A similar pattern of between-group differences was found for the secondary outcomes. The NHSWBP group generally had larger within group effects than the other groups and displayed a greater rate of change compared to the other conditions on all outcomes, except for gratitude, where the rate of change was greatest for the MPS group. CONCLUSIONS Conclusions: Our analyses provided encouraging results for the use of brief digital psychological interventions in improving psychological well-being among health and social care workers. Future multi-site RCTs, with power to reliably detect differences, are needed to determine the efficacy of contextualised interventions relative to existing digital treatments. CLINICALTRIAL Trial registration: ISRCTN18107122

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 Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e027952 ◽  
Author(s):  
Siobhan O'Higgins ◽  
Jennifer Stinson ◽  
Sara Ahola Kohut ◽  
Line Caes ◽  
Caroline Heary ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Support ◽  
Qualitative Content Analysis ◽  
Controlled Trial ◽  
Self Management ◽  
Advisory Panel ◽  
Post Intervention ◽  
Pilot Randomised Controlled Trial ◽  
Taking Charge ◽  
Randomised Controlled

IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.

scholarly journals Acceptability and feasibility pilot randomised controlled trial of medical skin camouflage for recovery of women prisoners with self-harm scarring (COVER): the study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021891
Author(s):  
Heather Mitchell ◽  
Kathryn M Abel ◽  
Brendan James Dunlop ◽  
Tammi Walker ◽  
Sandeep Ranote ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Self Esteem ◽  
Health Concern ◽  
Women Prisoners ◽  
Pilot Randomised Controlled Trial ◽  
North East ◽  
Self Harm ◽  
Randomised Controlled

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.

scholarly journals Evaluating the effectiveness and cost effectiveness of the ‘strengthening families, strengthening communities’ group-based parenting programme: study protocol and initial insights

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Annemarie Lodder ◽  
Anita Mehay ◽  
Hana Pavlickova ◽  
Zoe Hoare ◽  
Leandra Box ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Study Protocol ◽  
Well Being ◽  
Preventive Strategy ◽  
Parenting Interventions ◽  
Post Intervention ◽  
Parenting Programme ◽  
Randomised Controlled ◽  
Strengthening Families ◽  
Mental Well Being

Abstract Background Up to 20% of UK children experience socio-emotional difficulties which can have serious implications for themselves, their families and society. Stark socioeconomic and ethnic inequalities in children’s well-being exist. Supporting parents to develop effective parenting skills is an important preventive strategy in reducing inequalities. Parenting interventions have been developed, which aim to reduce the severity and impact of these difficulties. However, most parenting interventions in the UK focus on early childhood (0–10 years) and often fail to engage families from ethnic minority groups and those living in poverty. Strengthening Families, Strengthening Communities (SFSC) is a parenting programme designed by the Race Equality Foundation, which aims to address this gap. Evidence from preliminary studies is encouraging, but no randomised controlled trials have been undertaken so far. Methods/design The TOGETHER study is a multi-centre, waiting list controlled, randomised trial, which aims to test the effectiveness of SFSC in families with children aged 3–18 across seven urban areas in England with ethnically and socially diverse populations. The primary outcome is parental mental well-being (assessed by the Warwick-Edinburgh Mental Well-Being Scale). Secondary outcomes include child socio-emotional well-being, parenting practices, family relationships, self-efficacy, quality of life, and community engagement. Outcomes are assessed at baseline, post intervention, three- and six-months post intervention. Cost effectiveness will be estimated using a cost-utility analysis and cost-consequences analysis. The study is conducted in two stages. Stage 1 comprised a 6-month internal pilot to determine the feasibility of the trial. A set of progression criteria were developed to determine whether the stage 2 main trial should proceed. An embedded process evaluation will assess the fidelity and acceptability of the intervention. Discussion In this paper we provide details of the study protocol for this trial. We also describe challenges to implementing the protocol and how these were addressed. Once completed, if beneficial effects on both parental and child outcomes are found, the impact, both immediate and longer term, are potentially significant. As the intervention focuses on supporting families living in poverty and those from minority ethnic communities, the intervention should also ultimately have a beneficial impact on reducing health inequalities. Trial registration Prospectively registered Randomised Controlled Trial ISRCTN15194500.

scholarly journals Early Positive Approaches to Support (E-PAtS) for Families of Young Children With Intellectual Disability: A Feasibility Randomised Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Elinor Coulman ◽  
Nick Gore ◽  
Gwenllian Moody ◽  
Melissa Wright ◽  
Jeremy Segrott ◽  
...  
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Service Provider ◽  
Controlled Trial ◽  
Well Being ◽  
Retention Rates ◽  
Future Trial ◽  
Randomised Controlled ◽  
Mental Well Being ◽  
Post Randomisation

Background: Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS.Methods: This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures.Results: Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial.Conclusions: The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers.Clinical Trial Registration:https://www.isrctn.com, identifier: ISRCTN70419473.

scholarly journals Impact of a farmers’ market nutrition coupon programme on diet quality and psychosocial well-being among low-income adults: protocol for a randomised controlled trial and a longitudinal qualitative investigation

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035143 ◽  
Author(s):  
Michelle L Aktary ◽  
Stephanie Caron-Roy ◽  
Tolulope Sajobi ◽  
Heather O'Hara ◽  
Peter Leblanc ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Diet Quality ◽  
Low Income ◽  
Controlled Trial ◽  
Well Being ◽  
Farmers Markets ◽  
Post Intervention ◽  
Farmers Market ◽  
Randomised Controlled

IntroductionLow-income populations have poorer diet quality and lower psychosocial well-being than their higher-income counterparts. These inequities increase the burden of chronic disease in low-income populations. Farmers’ market subsidies may improve diet quality and psychosocial well-being among low-income populations. In Canada, the British Columbia (BC) Farmers’ Market Nutrition Coupon Programme (FMNCP) aims to improve dietary patterns and health among low-income participants by providing coupons to purchase healthy foods from farmers’ markets. This study will assess the impact of the BC FMNCP on the diet quality and psychosocial well-being of low-income adults and explore mechanisms of programme impacts.Methods and analysisIn a parallel group randomised controlled trial, low-income adults will be randomised to an FMNCP intervention (n=132) or a no-intervention control group (n=132). The FMNCP group will receive 16 coupon sheets valued at CAD$21/sheet over 10–15 weeks to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts and herbs at farmers’ markets and will be invited to participate in nutrition skill-building activities. Overall diet quality (primary outcome), diet quality subscores, mental well-being, sense of community, food insecurity and malnutrition risk (secondary outcomes) will be assessed at baseline, immediately post-intervention and 16 weeks post-intervention. Dietary intake will be assessed using the Automated Self-Administered 24-hour Dietary Recall. Diet quality will be calculated using the Healthy Eating Index-2015. Repeated measures mixed-effect regression will assess differences in outcomes between groups from baseline to 16 weeks post-intervention. Furthermore, 25–30 participants will partake in semi-structured interviews during and 5 weeks after programme completion to explore participants’ experiences with and perceived outcomes from the programme.Ethics and disseminationEthical approval was obtained from the University of Calgary Conjoint Health Research Ethics Board, Rutgers University Ethics and Compliance, and University of Waterloo Office of Research Ethics. Findings will be disseminated through policy briefs, conference presentations and peer-reviewed publications.Trial registration numberNCT03952338.

Feasibility and Acceptability of DemPower: A Couple Management App for Couples Where One Partner has a Dementia (Preprint)

2019 ◽  
Author(s):  
Reena Lasrado ◽  
Therese Bielsten ◽  
Mark Hann ◽  
James Schumm ◽  
Siobhan Reilly ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Self Management ◽  
Limited Attention ◽  
Post Intervention ◽  
Relational Networks ◽  
Health And Social Care ◽  
Diagnosis Of Dementia ◽  
Memory Clinics ◽  
Randomised Controlled ◽  
Study Participants

BACKGROUND The increasing rate of dementia and high health and social care costs call for effective measures to improve public health and enhance the wellbeing of people living with dementia and their relational networks. Most post diagnostic services focus on the condition and the person with dementia with limited attention to the spouse or partner caregiver. The key focus of the study is to develop a self-management guide for couples where one partner has a diagnosis of dementia. This couple self-management guide is delivered in the form of an app, DemPower. The contents of the app were organized into four main themes, ‘Home and Neighbourhood’, ‘Activities and Relationship’, ‘Meeting, Sharing and Caring’ ‘Communication and Emotions’. Each of these themes included a series of videos and activities for couples to do together. OBJECTIVE The study aimed to investigate the feasibility and acceptability of DemPower. METHODS The study used a non-randomized feasibility design. The study recruited 25 couples in the United Kingdom and 19 couples in Sweden. We aimed to complete the app within three months and collected usage data from the devices at the end of the study. Outcome measures were obtained at baseline and post intervention. RESULTS 21 couples completed the study (48%). Of these, 18 (86%) completed all parts of the app and each couple spent an average of 8hrs on the app during the study period. Among the four themes, ‘Home and Neighbourhood’ averaged 250 visits, ‘Activities and Relationship’ average 174 visits, ‘Meeting, Sharing and Caring’ average 160 and ‘Communication and Emotions’ received average 122 visits. Over the course of the study, participants visited suggested activities pages more frequently (average 95) than the core contents pages displaying section specific introductory videos (average 71) or videos of couples (average 69), for example taking pictures, physical exercise, talking to each other, walking, music and home adaptation checklist. CONCLUSIONS The findings suggest that the DemPower app is a useful resource for couples where one partner has a dementia and that its implementation requires the support of memory clinics to reach couples at early diagnosis. CLINICALTRIAL International Standard Randomised Controlled Trial Number (ISRCTN): 10122979; http://www.isrctn.com/ISRCTN10122979 (Archived by WebCite at http://www.webcitation.org/70rB1iWYI)

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