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

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          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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          Most cited references78

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          Using thematic analysis in psychology

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            Development and validation of brief measures of positive and negative affect: The PANAS scales.

            In recent studies of the structure of affect, positive and negative affect have consistently emerged as two dominant and relatively independent dimensions. A number of mood scales have been created to measure these factors; however, many existing measures are inadequate, showing low reliability or poor convergent or discriminant validity. To fill the need for reliable and valid Positive Affect and Negative Affect scales that are also brief and easy to administer, we developed two 10-item mood scales that comprise the Positive and Negative Affect Schedule (PANAS). The scales are shown to be highly internally consistent, largely uncorrelated, and stable at appropriate levels over a 2-month time period. Normative data and factorial and external evidence of convergent and discriminant validity for the scales are also presented.
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              The behaviour change wheel: A new method for characterising and designing behaviour change interventions

              Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.
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                Author and article information

                Contributors
                n.howlett@herts.ac.uk
                l.bottoms@herts.ac.uk
                angel.chater@beds.ac.uk
                allan.clark@uea.ac.uk
                timothy.clarke@nsft.nhs.uk
                lee.david@10minutecbt.co.uk
                k.irvine2@herts.ac.uk
                a.p.jones@uea.ac.uk
                j.jones26@herts.ac.uk
                s.mengoni@herts.ac.uk
                jamie.murdoch@uea.ac.uk
                martin.pond@uea.ac.uk
                s.3.sharma@herts.ac.uk
                E.Sims@uea.ac.uk
                david.a.turner@uea.ac.uk
                d.m.wellsted@herts.ac.uk
                jon.wilson@nsft.nhs.uk
                s.wyatt5@herts.ac.uk
                d.trivedi@herts.ac.uk
                Journal
                Pilot Feasibility Stud
                Pilot Feasibility Stud
                Pilot and Feasibility Studies
                BioMed Central (London )
                2055-5784
                4 January 2021
                4 January 2021
                2021
                : 7
                : 6
                Affiliations
                [1 ]GRID grid.5846.f, ISNI 0000 0001 2161 9644, Department of Psychology, Sport, and Geography, , University of Hertfordshire, ; College Lane, Hatfield, Herts AL10 9AB UK
                [2 ]GRID grid.15034.33, ISNI 0000 0000 9882 7057, Institute for Sport and Physical Activity Research (ISPAR), School of Sport Science and Physical Activity, Faculty of Health, Education, Sport and Social Science, , University of Bedfordshire, ; Polhill Avenue, Bedford, MK41 9EA UK
                [3 ]GRID grid.8273.e, ISNI 0000 0001 1092 7967, Norwich Clinical Trials Unit, , University of East Anglia, ; Norwich, Norfolk NR4 7TR UK
                [4 ]GRID grid.439884.a, ISNI 0000 0004 0417 7479, Norfolk and Suffolk NHS Foundation Trust, Hellesdon Hospital, ; Drayton High Road, Norwich, NR6 5BE UK
                [5 ]GRID grid.5846.f, ISNI 0000 0001 2161 9644, Centre for Health Services and Clinical Research, , University of Hertfordshire, ; College Lane, Hatfield, Herts AL10 9AB UK
                [6 ]GRID grid.8273.e, ISNI 0000 0001 1092 7967, Norwich Medical School, , University of East Anglia, ; Norwich, Norfolk NR4 7TJ UK
                [7 ]GRID grid.5846.f, ISNI 0000 0001 2161 9644, Centre for Research in Public Health and Community Care, , University of Hertfordshire, ; College Lane, Hatfield, Herts AL10 9AB UK
                Author information
                http://orcid.org/0000-0002-6502-9969
                Article
                734
                10.1186/s40814-020-00734-7
                7779325
                f3e3a7e2-5c69-4a31-aa4d-98df3abf4bdc
                © The Author(s) 2021

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 3 August 2020
                : 24 November 2020
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000664, Health Technology Assessment Programme;
                Award ID: 17/78/10
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2021

                depression,low mood,young people,exercise,physical activity,behaviour change,feasibility trial

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