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

Abstract Background: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strengths-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness, and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. Methods: This will be a pilot randomised controlled trial (RCT) comparing a strengths-based digital smartphone application (Peer Tree) with a treatment as usual (TAU) condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidality risk, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, post-intervention, and at follow-up. Participants in the TAU condition complete the same three assessment sessions. The primary outcomes of the study will be self-reported loneliness as well as the acceptability, usability, feasibility and safety of Peer Tree. Depression, social anxiety, and quality of life variables will also be measured as secondary outcomes. Discussion: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN12619000350123. Registered 6th March 2020

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Advance notice of contraceptive availability at surgical abortion: a pilot randomised controlled trial

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2017-200023 ◽

2018 ◽

Vol 44 (3) ◽

pp. 187-192 ◽

Cited By ~ 1

Author(s):

Andrea H Roe ◽

Jennifer Fortin ◽

Danielle Gelfand ◽

Elizabeth Janiak ◽

Rie Maurer ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Contraceptive Method ◽

Controlled Trial ◽

Secondary Outcome ◽

Pilot Randomised Controlled Trial ◽

Contraceptive Knowledge ◽

Advance Notice ◽

Randomised Controlled ◽

Surgical Abortion ◽

The Impact

BackgroundWith advance notice about the availability and effectiveness of contraceptive methods, abortion patients have more time and information for decision-making. We assessed the impact of an informational telephone call prior to the surgical abortion visit on patient contraceptive knowledge.MethodsThis was a pilot randomised controlled trial. Prior to their abortion visit, participants were randomised to the intervention message, a standardised notification about the availability, effectiveness and safety of long-acting (LARC) and short-acting reversible contraception (SARC) on the day of the abortion, or to the control message, a reiteration of appointment logistics without information about contraception. At the visit, participants completed a pre-procedure survey to assess contraceptive knowledge and usefulness of the intervention. The primary outcome was knowledge of LARC availability immediately after surgical abortion. A secondary outcome was contraceptive method uptake.ResultsWe enrolled 234 subjects. The pre-visit telephone notification improved knowledge that LARC is available immediately after surgical abortion (71.3% vs 50.9%, P<0.01). Participants in both study arms found the telephone notifications useful. Post-abortion contraceptive method choice did not differ between study arms.ConclusionsAdvance notice about contraception was acceptable to surgical abortion patients and improved their contraceptive knowledge.Trial registration numberNCT02836561.

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Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate)

BMJ Open ◽

10.1136/bmjopen-2017-015939 ◽

2017 ◽

Vol 7 (6) ◽

pp. e015939 ◽

Cited By ~ 7

Author(s):

Michael D Crossland ◽

Rachel Thomas ◽

Hilary Unwin ◽

Seelam Bharani ◽

Vijaya K Gothwal ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Young People ◽

Low Vision ◽

Controlled Trial ◽

Tablet Computers ◽

Children And Young People ◽

Pilot Randomised Controlled Trial ◽

Randomised Controlled

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

Pilot and Feasibility Studies ◽

10.1186/s40814-020-00734-7 ◽

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.

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