scholarly journals A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
N. Howlett ◽  
L. Bottoms ◽  
A. Chater ◽  
A. B. Clark ◽  
T. Clarke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Large Scale ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Exercise Session ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration ISRCTN, ISRCTN66452702. Registered 9 April 2020.

scholarly journals Using neuroimaging to investigate the impact of Mandolean® training in young people with obesity: a pilot randomised controlled trial

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Elanor C. Hinton ◽  
Laura A. Birch ◽  
John Barton ◽  
Jeffrey M. P. Holly ◽  
Kalina M. Biernacka ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled ◽  
The Impact

scholarly journals Evaluating Palin Stammering Therapy for School Children (Palin STSC 8-14): Protocol for a Feasibility Randomised Control Trial Comparing Palin STSC(8-14) with Usual Treatment

2021 ◽  
Author(s):  
Sharon K Millard ◽  
Suzanne Murphy ◽  
Garry Barton ◽  
Maria Lethersich ◽  
Lorna Rixon ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Peer Relations ◽  
School Children ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Randomised Control Trial ◽  
Treatment As Usual ◽  
Children And Parents ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Having a stammer can have a significant effect on a child’s social, emotional and educational development. With approximately 66,000 children in the UK having a stammer, there is a need to establish an adequate evidence base to inform clinical practise. We describe a feasibility trial to explore the effectiveness of a new therapy programme for children aged 8-14: Palin Stammering Therapy for School Children (Palin STSC(8-14)). Preliminary data from the Michael Palin Centre, where the programme was developed, indicate that Palin STSC(8-14) is effective in reducing stammering frequency and impact for children, with beneficial effects for parents too. We will investigate the feasibility of the methods required for a definitive randomised control trial to investigate the application of this therapy by NHS speech and language therapists (SLTs), compared with ‘treatment as usual’ (TAU), beyond the specialist context in which it was developed.Methods: This is a two-arm feasibility cluster-randomised controlled trial of Palin STSC(8-14) with TAU control arm, and randomisation at the level of the SLT. Quantitative and qualitative data will be collected to examine: the recruitment and retention of therapists and families; the acceptability of the research processes and the therapeutic intervention; the appropriateness of the therapy outcome measures. Assessments will be completed by children and parents at baseline and six months later, including measures of: stammering severity; the impact of child’s stammering on both children and parents; child temperament, behaviour, peer relations, anxiety; quality of life; and, economic outcomes. There will also be a qualitative process evaluation, including interviews with parents, children, SLTs and SLT managers to explore the acceptability of both the research and therapy methods. Treatment fidelity will be examined through analysis of therapy session records and recordings. Discussion: The findings of this feasibility trial will inform the decision as to whether to progress to a full-scale randomised controlled trial to explore the effectiveness of Palin STSC(8-14) when compared to Treatment as Usual in NHS SLT services. There is a strong need for an evidence based intervention for school age children who stammer. Trial registration: ISRCTN. ISRCTN17058884. Registered 18th December 2019. https://www.isrctn.com/ISRCTN17058884

scholarly journals FACT: a randomised controlled trial to assess the feasibility of QbTest in the assessment process of attention deficit hyperactivity disorder (ADHD) for young people in prison—a feasibility trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e035519
Author(s):  
Charlotte Lennox ◽  
Charlotte Lucy Hall ◽  
Lesley-Anne Carter ◽  
Bryony Beresford ◽  
Susan Young ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Usual Care ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Assessment Process ◽  
Feasibility Trial ◽  
Hyperactivity Disorder ◽  
Randomised Controlled

IntroductionThe prevalence of attention deficit hyperactivity disorder (ADHD) within the Children and Young People Secure Estate (CYPSE) is much higher than seen in the general population. To make a diagnosis of ADHD, clinicians draw on information from multiple sources, including parents and teachers. However, obtaining these is particularly difficult for young people in the secure estate. There is increasing evidence in the community that QbTest is able to assist in the accurate and earlier diagnosis of ADHD. The objective of this study is to assess the feasibility and acceptability of QbTest in the assessment of ADHD within the CYPSE.Methods and analysisA single-centre parallel group feasibility randomised controlled trial will be conducted. Sixty young people within the CYPSE identified as displaying possible symptoms of ADHD will be randomised to the intervention arm (n=30; QbTest plus usual care) or control arm (n=30; usual care). Primary analyses will be descriptive and a process evaluation will be conducted to assess the contexts involved in implementing the intervention. Interviews will be conducted to explore acceptability and thematic analysis will be used to analyse the data.Ethics and disseminationThis study was approved by National Health Service Wales research ethics committee 3 (18/WA/0347) on 15 February 2019. The findings will be published in peer-reviewed journals, presented at relevant conferences and disseminated to the public via summaries cocreated with our patient and public involvement group.Trial registration numberISRCTN17402196

scholarly journals Promoting physical activity in vulnerable adults ‘at risk’ of homelessness: a randomised controlled trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e026466 ◽  
Author(s):  
Charlotte Stringer ◽  
Mike Loosemore ◽  
Eloise Moller ◽  
Sarah E Jackson ◽  
Guillermo Felipe López-Sánchez ◽  
...  
Keyword(s):  
Mental Health ◽  
Physical Activity ◽  
At Risk ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
The Impact ◽  
Mental And Physical Health

IntroductionPeople who are homeless, or at risk of homelessness, have substantially poorer health. Sustained and regular participation in physical activity is beneficial for both mental and physical health. Limited data suggest that levels of physical activity in the homeless and those at risk of homelessness are low, and access to community-based exercise is limited or non-existent for this population. Nonetheless, exercise programmes for the homeless could provide a feasible and scalable intervention for providing beneficial effects on physical and mental health in this population. The primary aim of this study is to evaluate the impact of a group exercise intervention on activity levels in people who are homeless or at risk of homelessness in central London, UK. The secondary aim is to evaluate the impact of the intervention on mental and physical health outcomes.Method and analysisA 2-arm, individually randomised controlled trial in people who are homeless and those vulnerable and at risk of homelessness in central London, UK. Participants will be recruited through a London-based homeless charity, Single Homeless Project. Following baseline assessments and allocation to intervention (exercise classes) or control (usual care), participants will be followed up at 3, 6, 9 and 12 months. The primary outcomes will be change in objective physical activity. The secondary outcomes will include change in fitness assessments and mental health parameters. Changes in drug use and alcohol dependency will also be explored.Ethics and disseminationEthical approval to process and analyse data and disseminate findings was obtained through the Anglia Ruskin University Department of Sport and Exercise Sciences Research Ethics Committee. Results of this study will be disseminated through peer-reviewed publications and scientific presentations.

scholarly journals INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e029185
Author(s):  
Richard Collings ◽  
Jennifer A Freeman ◽  
Jos Latour ◽  
Patricia Jane Vickery ◽  
Sam Glasser ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Diabetic Neuropathy ◽  
Usual Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Control Group ◽  
Foot Ulceration ◽  
Randomised Controlled

IntroductionFoot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.AimThis study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.Methods and analysisThis study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.Ethics and disseminationThe study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.Trials registration numberISRCTN16011830; Pre-results.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

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