scholarly journals Protocol for the Work Engagement and Well-being Study (SWELL): A randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work

2021 ◽  
Author(s):  
Maris Vainre ◽  
Julieta Galante ◽  
Peter Watson ◽  
Tim Dalgleish ◽  
Caitlin Hitchcock
Keyword(s):  
Physical Exercise ◽  
Work Performance ◽  
Controlled Trial ◽  
Well Being ◽  
Performance Outcomes ◽  
Feasibility Trial ◽  
Post Intervention ◽  
Randomised Controlled ◽  
Preventative Interventions

Mental ill health is a major cause of disability. Workplaces are attractive for preventative interventions since most adults work while employers are interested in improving employees’ well-being and productivity. Mindfulness-based programmes are increasingly in occupational settings. However, there is inconsistent evidence whether mindfulness interventions improve work performance and how effective mindfulness-based programmes are, compared to other interventions, in preventing mental ill health.In this online randomised controlled feasibility trial, an anticipated 240 employees will be randomised to either a 4-week light physical exercise course or a mindfulness course of the same duration (1:1 allocation). The primary outcome is work performance, measured using the Work Role Functioning Questionnaire. We aim to evaluate the acceptability, feasibility, and procedural uncertainties of a randomised controlled trial in a workplace, calculate an effect size estimate to inform power calculations for a larger trial, and explore whether improved executive function and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance. Outcomes will be collected at baseline, post-intervention and 12-week follow-up.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

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 A randomised controlled trial to investigate the effectiveness of sustained photoprotective behaviour in xeroderma pigmentosum after intervention

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S287-S287
Author(s):  
Tamara Searle ◽  
Jessica Walburn ◽  
Sam Norton
Keyword(s):  
Randomised Controlled Trial ◽  
Self Efficacy ◽  
Xeroderma Pigmentosum ◽  
Controlled Trial ◽  
Premalignant Lesions ◽  
Mental Wellbeing ◽  
Group Effect ◽  
Post Intervention ◽  
Randomised Controlled

AimsThis study aimed to investigate whether an intervention designed to improve photoprotective behaviours is effective at changing behaviour and whether any change could be maintained.BackgroundXeroderma Pigmentosum (XP) is a rare condition in which patients are at risk of malignancies when exposed to ultra-violet radiation (UVR). Sufferers must take extra precautions to protect themselves from UVR. They must apply sunscreen to exposed skin, wear thick clothing, gloves, and a UVR-protective visor. Treatments include preventative photoprotective measures; the use of sunscreen and protective clothing. Additionally, frequent eye and skin examinations are required and swift removal of any premalignant lesions.MethodIn this randomised controlled trial, 16 participants with XP were given questionnaires at 4 time points; baseline, post-intervention, 5 months and 9 months post-intervention. The intervention involved 7 one-on-one counselling sessions, as well as telephone consultations. Counselling sessions encouraged photoprotection adherence, self-efficacy and discussions of any barriers to improving photoprotective behaviour. This study focused on psychosocial variables, attitudes and photoprotection. Questionnaires included the photoprotection self-efficacy questionnaire, Self-Reported Behavioural Automaticity Index, Short Warwick-Edinburgh Mental Wellbeing Scale, Quality of Life and Brief Photoprotection Adherence Questionnaire.ResultThe intervention was shown to have no significant effect on participants’ questionnaires scores. Univariate ANCOVA revealed a group effect between follow-up 1 (FU1) and follow-up 2 (FU2); η2 = 0.422 for self-efficacy in wearing photoprotective clothing. A group effect was identified from BL to FU1 and FU1 to FU2; η2 = 0.343 and η2 = 0.378 respectively in how often participants reapplied sunscreen to their face when outside for longer periods. Univariate ANCOVA revealed no group or time effect for the other outcome variables; for example, sunscreen self-efficacy.ConclusionThe intervention had no significant effect on photoprotective behaviour questionnaire scores. Future research could focus on recruiting more participants globally to generate more statistically powered results. Research should focus on producing a maintainable intervention so that any positive change would produce better long-term health outcomes. This study lays the foundations for future XP research, which will be vital to improve understanding and enhance photo protective behaviour.

scholarly journals A randomised controlled trial of adjunctive yoga and adjunctive physical exercise training for cognitive dysfunction in schizophrenia

2016 ◽  
Vol 29 (2) ◽  
pp. 102-114 ◽  
Author(s):  
Triptish Bhatia ◽  
Sati Mazumdar ◽  
Joel Wood ◽  
Fanyin He ◽  
Raquel E. Gur ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Physical Exercise ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Cognitive Domains ◽  
Physical Exercise Training ◽  
Randomised Controlled

BackgroundYoga and physical exercise have been used as adjunctive intervention for cognitive dysfunction in schizophrenia (SZ), but controlled comparisons are lacking.AimsA single-blind randomised controlled trial was designed to evaluate whether yoga training or physical exercise training enhance cognitive functions in SZ, based on a prior pilot study.MethodsConsenting, clinically stable, adult outpatients with SZ (n=286) completed baseline assessments and were randomised to treatment as usual (TAU), supervised yoga training with TAU (YT) or supervised physical exercise training with TAU (PE). Based on the pilot study, the primary outcome measure was speed index for the cognitive domain of ‘attention’ in the Penn computerised neurocognitive battery. Using mixed models and contrasts, cognitive functions at baseline, 21 days (end of training), 3 and 6 months post-training were evaluated with intention-to-treat paradigm.ResultsSpeed index of attention domain in the YT group showed greater improvement than PE at 6 months follow-up (p<0.036, effect size 0.51). In the PE group, ‘accuracy index of attention domain showed greater improvement than TAU alone at 6-month follow-up (p<0.025, effect size 0.61). For several other cognitive domains, significant improvements were observed with YT or PE compared with TAU alone (p<0.05, effect sizes 0.30–1.97).ConclusionsBoth YT and PE improved attention and additional cognitive domains well past the training period, supporting our prior reported beneficial effect of YT on speed index of attention domain. As adjuncts, YT or PE can benefit individuals with SZ.

scholarly journals Promoting independence in dementia: protocol for a feasibility trial of the PRIDE intervention for living well with dementia

2018 ◽  
Vol 5 (4) ◽  
pp. 177 ◽  
Author(s):  
Emese Csipke ◽  
Lauren Yates ◽  
Esme Moniz Cook ◽  
Phuong Leung ◽  
Georgina Charlesworth ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Measure Data ◽  
Structured Interviews ◽  
Post Intervention ◽  
Mild Dementia ◽  
Living Well ◽  
People With Dementia ◽  
Randomised Controlled

<p class="abstract"><strong>Background:</strong> Dementia can lead to social exclusion, loss of identity and independence, due to deterioration in cognition and activities of daily living. The aim of the study is to investigate the feasibility of the Promoting Independence in Dementia (PRIDE) intervention, designed to facilitate independence in people with mild dementia.</p><p class="abstract"><strong>Methods:</strong> This is a mixed-methods feasibility trial of the PRIDE, in preparation for a future randomised controlled trial. Up to 50 people with dementia will be recruited. Demetia advisors will deliver the three session intervention. Quantitative outcomes will be taken at baseline and up to three months post baseline. Fidelity checklists will assess fidelity to the intervention. Qualitative implementation data will be gathered in a series of post-intervention semi-structured interviews with staff and participants. This will include data to examine participant experiences of and engagement with the intervention, and other aspects of delivery such as recruitment of DAWs, fidelity and experiences of receiving and delivering the intervention. This study aims to establish and field test the PRIDE intervention; determine the recruitment rate of sites, providers and participants; assess fidelity in delivery of the intervention and engagement with people with dementia; assess the feasibility and acceptability of outcome measure data and assess the acceptability of the intervention by stakeholders.</p><p class="abstract"><strong>Conclusions: </strong>There has been increased need for non-pharmacological interventions for mild dementia. The results of this feasibility study will allow us to plan for a definitive RCT of a three session dementia advisor led intervention for mild dementia.</p>

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.

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

Promoting post-traumatic growth in cancer patients: A study protocol for a randomized controlled trial of guided written disclosure

2016 ◽  
Vol 24 (2) ◽  
pp. 240-253 ◽  
Author(s):  
Valentina Cafaro ◽  
Luca Iani ◽  
Massimo Costantini ◽  
Silvia Di Leo
Keyword(s):  
Cancer Patients ◽  
Psychological Health ◽  
Controlled Trial ◽  
Well Being ◽  
Daily Routine ◽  
Post Intervention ◽  
Writing Interventions ◽  
Post Traumatic Growth ◽  
Post Traumatic

This multicenter study investigates the efficacy of the guided disclosure protocol in promoting post-traumatic growth, through meaning reconstruction, in cancer patients after adjuvant chemotherapy. Participants will be randomized to guided disclosure protocol or to an active control condition. Both conditions consist of three 20-minute writing sessions. Experimental participants verbalize emotions, describe events, and reflect on trauma effects. Control participants write about their past week’s daily routine. Patients, blinded to treatment assignment, will complete questionnaires at pre-intervention, post-intervention, and 6-month follow-up. This study will improve knowledge concerning the effects of writing interventions on psychological health and well-being in cancer patients.

scholarly journals Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lucie Waedel ◽  
Anne Daubmann ◽  
Antonia Zapf ◽  
Olaf Reis
Keyword(s):  
Substance Use ◽  
Randomised Controlled Trial ◽  
Intellectual Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Post Intervention ◽  
Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

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.

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