A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the TREAD trial
- Funder: HTA
- ENHS Lead: Dr Anne Haase
- Co-researchers: Prof Glyn Lewis, Prof A Taylor, Prof Ken Fox, Dr Nicola Wiles, Prof John Campbell, Dr Sandra Hollinghurst, Dr Katrina Turner, Prof Michael Calnan, Dr Alan Montgomery, Prof Debbie Lawlor, Prof Tim Peters, Prof Debbie Sharp
- Research Centre: Exercise Nutrition and Health Sciences
The main aim of the TREAD-UK trial was to investigate the effectiveness of facilitated physical activity as an adjunctive treatment for adults with depression who present in primary care. Using a pragmatic, multicentre, two arm parallel randomised controlled trial design, 361 adults aged 18-69 who had recently consulted their general practitioner with symptoms ofdepression were recruited from general practices in SouthWest England. 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. 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.
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.
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). 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.
- Searle A, Haase AM, Chalder M, Fox KR, Taylor AH, Lewis G, Turner KM. (2013). Participant experiences of facilitated physical activity for the management of depression in primary care. Journal of Health Psychology. epub 10 September 2013; DOI: 10.1177/1359105313493648.
- Chalder M, Wiles NJ, Campbell J, Hollinghurst SP, Haase AM, Taylor AH, Fox KR, Costelloe C, Searle A, Baxter H, Winder R, Wright C, Turner K, Calnan M, Lawlor DA, Peters TJ, Sharp DJ, Montgomery AA, Lewis G. (2012). Facilitated physical activity as a treatment for depressed adults: randomised controlled trial. British Medical Journal, 344:e2758. doi: 10.1136/bmj.e2758.
- Chalder MJE, Wiles NJ, Campbell J, Hollinghurst S, Searle AJ, Haase AM, Taylor AH, Fox KR, Baxter H, Davis MG, Thorp HE Winder R, Wright C, Calnan M, Lawlor D, Peters TJ, Sharp D, Turner K, Montgomery AA & Lewis G. (2012). 'A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the TREAD trial', NHS Health Technology Assessment (HTA) Report, 16 (10)
- Baxter H, Winder R, Chalder M, Wright C, Sherlock S, Haase A, Wiles N, Montgomery A, Taylor A, Fox K, Lawlor D, Peters T, Sharp D, Campbell J, Lewis G. (2010). Physical activity as a treatment for depression: the TREAD randomised trial protocol. BMC Trials, 11, 105-111.
- Haase AM, Taylor AH, Fox KF, Thorp H, Lewis G. (2010). Rationale and development of the physical activity counselling intervention for a pragmatic Trial of Exercise and Depression in the UK (TREAD-UK). Mental Health and Physical Activity, 3, 85-91. doi: 10.1016/j.mhpa.2010.09.004.