You are here

  • Home
  • Archive
  • Volume 9, Issue 10
  • 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, i…

Article Text

Article menu

Download PDFPDF

XML
Mental health
Protocol
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
  1. Alexandra G. Parker1,2,3,
  2. Connie Markulev2,3,
  3. Debra J. Rickwood4,5,
  4. Andrew Mackinnon6,7,
  5. Rosemary Purcell2,3,
  6. Mario Alvarez-Jimenez2,3,
  7. Alison R. Yung3,8,
  8. Patrick McGorry2,3,
  9. Sarah E. Hetrick3,9,
  10. Anthony Jorm6
  1. 1 Institute for Health and Sport, Victoria University, Footscray, Victoria, Australia
  2. 2 Centre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia
  3. 3 Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Victoria, Australia
  4. 4 Department of Psychology, University of Canberra, Canberra, Australian Capital Territory, Australia
  5. 5 headspace, National Youth Mental Health Foundation, Melbourne, Victoria, Australia
  6. 6 School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia
  7. 7 The University of New South Wales, Black Dog Institute, Randwick, New South Wales, Australia
  8. 8 School of Health Sciences, The University of Manchester, Manchester, United Kingdom
  9. 9 Department of Psychological Medicine, University of Auckland, Auckland, New Zealand
  1. Correspondence to Professor Alexandra G. Parker; alexandra.parker{at}vu.edu.au

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.

  • MENTAL HEALTH
  • Depression & mood disorders
  • Clinical trials

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/.

https://doi.org/10.1136/bmjopen-2019-034002

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors AGP led the development of this manuscript. AGP, DJR, AM, RP, MA-J, ARY, PM, SH and AJ secured the funding for the project and, together with author CM, devised the research design and measures. AGP, CM, DR, RP, MA-J, ARY, PM, SH and AJ were involved in devising the intervention content and intervention implementation strategies, which were based on those established and previously operated by AGP, RP, ARY, PM, SH and AJ. AM was primarily responsible for the sample size and power calculations and development of proposed statistical analyses. AGP wrote the initial draft of the manuscript. All authors contributed to and approved the final version of the manuscript.

    • Funding This work was supported by a National Health and Medical Research Council (NHMRC) Project Grant (GNT1063033) titled ‘Physical activity for young people with depression: A cluster randomised controlled trial to test the effectiveness of incorporating a brief intervention into routine clinical care’. AJ received salary support from an NHMRC Senior Principal Research Fellowship (APP1059785). AY received salary support from an NHMRC Principal Research Fellowship (APP1136829). Study sponsor: the study is sponsored by the Sponsor Operations Department, Orygen, The National Centre of Excellence in Youth Mental Health. Contact details: 35 Poplar Road, Parkville, Victoria, Australia 3052. A risk assessment of the study conducted by the study sponsor determined that a data monitoring committee was not needed due to the low-risk nature of the intervention.

    • Disclaimer The funding body has had no role in the study design or the decision to submit the manuscript for publication. The study sponsor has had no role in the study design or the decision to submit the manuscript for publication.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Data availability statement There are no data in this work.