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      Improving Mood with Physical ACTivity (IMPACT) trial: a cluster randomised controlled trial to determine the effectiveness of a brief physical activity behaviour change intervention on depressive symptoms in young people, compared with psychoeducation, in addition to routine clinical care within youth mental health services—a protocol study

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          Abstract

          Introduction

          Depression is highly prevalent and the leading contributor to the burden of disease in young people worldwide, making it an ongoing priority for early intervention. As the current evidence-based interventions of medication and psychological therapy are only modestly effective, there is an urgent need for additional treatment strategies. This paper describes the rationale of the Improving Mood with Physical ACTivity (IMPACT) trial. The primary aim of the IMPACT trial is to determine the effectiveness of a physical activity intervention compared with psychoeducation, in addition to routine clinical care, on depressive symptoms in young people. Additional aims are to evaluate the intervention effects on anxiety and functional outcomes and examine whether changes in physical activity mediate improvements in depressive symptoms.

          Methods and analysis

          The study is being conducted in six youth mental health services across Australia and is using a parallel-group, two-arm, cluster randomised controlled trial design, with randomisation occurring at the clinician level. Participants aged between 12 years and 25 years with moderate to severe levels of depression are randomised to receive, in addition to routine clinical care, either: (1) a physical activity behaviour change intervention or (2) psychoeducation about physical activity. The primary outcome will be change in the Quick Inventory of Depressive Symptomatology, with assessments occurring at baseline, postintervention (end-point) and 6-month follow-up from end-point. Secondary outcome measures will address additional clinical outcomes, functioning and quality of life. IMPACT is to be conducted between May 2014 and December 2019.

          Ethics and dissemination

          Ethical approval was obtained from the University of Melbourne Human Research Ethics Committee on 8 June 2014 (HREC 1442228). Trial findings will be published in peer-reviewed journals and presented at conferences. Key messages will also be disseminated by the youth mental health services organisation (headspace National Youth Mental Health Foundation).

          Trial registration number

          ACTRN12614000772640.

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          Most cited references35

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          Global burden of disease in young people aged 10-24 years: a systematic analysis.

          Fiona M Gore, Paul J N Bloem, George C Patton … (2011)
          Young people aged 10-24 years represent 27% of the world's population. Although important health problems and risk factors for disease in later life emerge in these years, the contribution to the global burden of disease is unknown. We describe the global burden of disease arising in young people and the contribution of risk factors to that burden. We used data from WHO's 2004 Global Burden of Disease study. Cause-specific disability-adjusted life-years (DALYs) for young people aged 10-24 years were estimated by WHO region on the basis of available data for incidence, prevalence, severity, and mortality. WHO member states were classified into low-income, middle-income, and high-income countries, and into WHO regions. We estimated DALYs attributable to specific global health risk factors using the comparative risk assessment method. DALYs were divided into years of life lost because of premature mortality (YLLs) and years lost because of disability (YLDs), and are presented for regions by sex and by 5-year age groups. The total number of incident DALYs in those aged 10-24 years was about 236 million, representing 15·5% of total DALYs for all age groups. Africa had the highest rate of DALYs for this age group, which was 2·5 times greater than in high-income countries (208 vs 82 DALYs per 1000 population). Across regions, DALY rates were 12% higher in girls than in boys between 15 and 19 years (137 vs 153). Worldwide, the three main causes of YLDs for 10-24-year-olds were neuropsychiatric disorders (45%), unintentional injuries (12%), and infectious and parasitic diseases (10%). The main risk factors for incident DALYs in 10-24-year-olds were alcohol (7% of DALYs), unsafe sex (4%), iron deficiency (3%), lack of contraception (2%), and illicit drug use (2%). The health of young people has been largely neglected in global public health because this age group is perceived as healthy. However, opportunities for prevention of disease and injury in this age group are not fully exploited. The findings from this study suggest that adolescent health would benefit from increased public health attention. None. Copyright © 2011 Elsevier Ltd. All rights reserved.
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            The Lancet Psychiatry Commission: a blueprint for protecting physical health in people with mental illness

            Joseph Firth, Najma Siddiqi, Ai Koyanagi … (2019)
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              What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice.

              John Weisz, Sofie Kuppens, Mei Ng … (2017)
              Across 5 decades, hundreds of randomized trials have tested psychological therapies for youth internalizing (anxiety, depression) and externalizing (misconduct, attention deficit and hyperactivity disorder) disorders and problems. Since the last broad-based youth meta-analysis in 1995, the number of trials has almost tripled and data-analytic methods have been refined. We applied these methods to the expanded study pool (447 studies; 30,431 youths), synthesizing 50 years of findings and identifying implications for research and practice. We assessed overall effect size (ES) and moderator effects using multilevel modeling to address ES dependency that is common, but typically not modeled, in meta-analyses. Mean posttreatment ES was 0.46; the probability that a youth in the treatment condition would fare better than a youth in the control condition was 63%. Effects varied according to multiple moderators, including the problem targeted in treatment: Mean ES at posttreatment was strongest for anxiety (0.61), weakest for depression (0.29), and nonsignificant for multiproblem treatment (0.15). ESs differed across control conditions, with "usual care" emerging as a potent comparison condition, and across informants, highlighting the need to obtain and integrate multiple perspectives on outcome. Effects of therapy type varied by informant; only youth-focused behavioral therapies (including cognitive-behavioral therapy) showed similar and robust effects across youth, parent, and teacher reports. Effects did not differ for Caucasian versus minority samples, but more diverse samples are needed. The findings underscore the benefits of psychological treatments as well as the need for improved therapies and more representative, informative, and rigorous intervention science. (PsycINFO Database Record
              Article 0 comments Cited 203 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2019
                Publication date (Electronic): 28 October 2019
                Volume: 9
                Issue: 10
                Electronic Location Identifier: e034002
                Affiliations
                [1 ] departmentInstitute for Health and Sport , Victoria University , Footscray, Victoria, Australia
                [2 ] departmentCentre for Youth Mental Health , The University of Melbourne , Melbourne, Victoria, Australia
                [3 ] Orygen, The National Centre of Excellence in Youth Mental Health , Parkville, Victoria, Australia
                [4 ] departmentDepartment of Psychology , University of Canberra , Canberra, Australian Capital Territory, Australia
                [5 ] headspace, National Youth Mental Health Foundation , Melbourne, Victoria, Australia
                [6 ] School of Population and Global Health, The University of Melbourne , Melbourne, Victoria, Australia
                [7 ] departmentThe University of New South Wales , Black Dog Institute , Randwick, New South Wales, Australia
                [8 ] departmentSchool of Health Sciences , The University of Manchester , Manchester, United Kingdom
                [9 ] departmentDepartment of Psychological Medicine , University of Auckland , Auckland, New Zealand
                Author notes
                [Correspondence to ] Professor Alexandra G. Parker; alexandra.parker@ 123456vu.edu.au
                Author information
                http://orcid.org/0000-0002-2398-6306
                Article
                Publisher ID: bmjopen-2019-034002
                DOI: 10.1136/bmjopen-2019-034002
                PMC ID: 6830686
                PubMed ID: 31662409
                SO-VID: e337239a-2bf4-4691-9d0b-807d206605af
                Copyright © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 01 September 2019
                Date revision received : 29 September 2019
                Date accepted : 02 October 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Award ID: GNT1063033
                Categories
                Subject: Mental Health
                Subject: Protocol
                Subject: 1506
                Subject: 1712
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: mental health,depression & mood disorders,clinical trials
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: mental health, depression & mood disorders, clinical trials

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