Facilitated physical activity as a treatment for depressed adults: randomised controlled trialBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e2758 (Published 06 June 2012) Cite this as: BMJ 2012;344:e2758
- Melanie Chalder, research fellow1,
- Nicola J Wiles, senior lecturer1,
- John Campbell, professor2,
- Sandra P Hollinghurst, senior lecturer1,
- Anne M Haase, senior lecturer3,
- Adrian H Taylor, professor4,
- Kenneth R Fox, professor3,
- Ceire Costelloe, research associate1,
- Aidan Searle, research associate1,
- Helen Baxter, research associate1,
- Rachel Winder, associate research fellow2,
- Christine Wright, associate research fellow2,
- Katrina M Turner, lecturer1,
- Michael Calnan, professor5,
- Deborah A Lawlor, professor1,
- Tim J Peters, professor6,
- Deborah J Sharp, professor1,
- Alan A Montgomery, reader1,
- Glyn Lewis, professor1
- 1School of Social and Community Medicine, University of Bristol, Bristol BS8 2BN, UK
- 2Primary Care Research Group, Peninsula Medical School, Exeter, UK
- 3School of Policy Studies, University of Bristol
- 4Sport and Health Sciences, University of Exeter, Exeter
- 5School of Social Policy, University of Kent, Canterbury, UK
- 6School of Clinical Sciences, University of Bristol
- Correspondence to: M Chalder
- Accepted 22 March 2012
Objective To investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression presenting in primary care.
Design Pragmatic, multicentre, two arm parallel randomised controlled trial.
Setting General practices in Bristol and Exeter.
Participants 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms of depression. All those randomised had a diagnosis of an episode of depression as assessed by the clinical interview schedule-revised and a Beck depression inventory score of 14 or more.
Interventions In addition to usual care, intervention participants were offered up to three face to face sessions and 10 telephone calls with a trained physical activity facilitator over eight months. The intervention was based on theory and aimed to provide individually tailored support and encouragement to engage in physical activity.
Main outcome measures The primary outcome was self reported symptoms of depression, assessed with the Beck depression inventory at four months post-randomisation. Secondary outcomes included use of antidepressants and physical activity at the four, eight, and 12 month follow-up points, and symptoms of depression at eight and 12 month follow-up.
Results There was no evidence that participants offered the physical activity intervention reported improvement in mood by the four month follow-up point compared with those in the usual care group; adjusted between group difference in mean Beck depression inventory score −0.54 (95% confidence interval −3.06 to 1.99; P=0.68). Similarly, there was no evidence that the intervention group reported a change in mood by the eight and 12 month follow-up points. Nor was there evidence that the intervention reduced antidepressant use compared with usual care (adjusted odds ratio 0.63, 95% confidence interval 0.19 to 2.06; P=0.44) over the duration of the trial. However, participants allocated to the intervention group reported more physical activity during the follow-up period than those allocated to the usual care group (adjusted odds ratio 2.27, 95% confidence interval 1.32 to 3.89; P=0.003).
Conclusions The addition of a facilitated physical activity intervention to usual care did not improve depression outcome or reduce use of antidepressants compared with usual care alone.
Trial registration Current Controlled Trials ISRCTN16900744.
We thank the patients and staff who participated in the trial; members of our trial steering committee and data monitoring committee for their valuable support throughout the research (Michael King, Chris Dowrick, Margaret Thorogood, Paul Lanham, Helen Lester, Kerry Hood, and Keith Lloyd); the Mental Health Research Network and Primary Care Research Network in connection with data collection; the contribution of the Department of Health and local primary care trusts in meeting the excess treatment and service support costs associated with the trial; and the following colleagues who contributed to the recruitment and retention of patients, provided administrative support to the study, or delivered the intervention to study participants: Georgina Bentley, Susan Bryant, Amanda Burston, Kate Button, Julia Carver, Joy Choules, Sarah Dawkins, Nathan Filer, Davina Chauhan, Emily Gale, Alice Garrood, Charlotte Hale, Caroline Jenkinson, Rhodri Lewis, Linda Mottram, Adam Saint, Sofie Sherlock, Helen Thorp, Tom Thompson, Alison Wellingham, and Joanna Yarham. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the Department of Health.
Contributors: AMH, NJW, AAM, SPH AHT, KRF, DAL, TJP, DJS, JC, and GL were responsible for the initial proposal, securing funding for the trial, and drafting the original protocol. GL, as principal investigator, had overall management responsibility for the study. MC, as trial coordinator, was responsible for the day to day operationalisation of the trial and monitored data collection. AMH, KRF, AHT, and GL developed the physical activity intervention. All authors contributed to the refinement of the trial protocol and development of the data collections tools. HB, RW, CW, and AS were responsible for data collection and revised the draft paper. MC, NJW, AAM, TJP, DAL, and GL wrote the statistical analysis plan. MC and GL carried out the cleaning, analysis, and interpretation of the data with the assistance of CC, NJW, and AAM. MC and GL wrote the initial draft of the manuscript. All authors contributed to and approved the final manuscript on behalf of the wider research team. MC and CC used data from the study for their PhD and MSc theses, respectively.
Funding: This research was carried out independently by the University of Bristol, University of Exeter and the Peninsula Medical School. It is funded by the Department of Health as part of the National Institute for Health Research Health Technology Assessment programme.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the West Midlands multicentre research ethics committee (MREC 05/MRE07/42), and research governance approval was given by the relevant local National Health Service primary care trusts. The research is listed on the National Research Register and the International Standard Clinical Trial Register.
Data sharing: No additional data available.
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