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Complex interventions in a mental health setting : using a pragmatic randomised controlled trial (TREAD) to evaluate an innovative non-pharmacological treatment for depression

Depression is a common and disabling condition which is often treated with antidepressant medication within the primary care setting. There is growing interest in the possibility that non-pharmacological treatments such as physical activity could lead to a reduction in depressive symptoms. A pragmatic, multi-centre, two-arm, parallel, individually-randomised controlled trial investigated the effectiveness of a facilitated physical activity intervention as an adjunctive treatment to usual care for adults presenting to general practitioners with depression. The intervention comprised three face-to-face sessions and ten telephone calls with a Physical Activity Facilitator over an 8-month period. The primary outcome was depressive symptoms assessed using the Beck Depression Inventory at 4-month follow-up. Secondary . outcomes included quality of life, prescription and use of antidepressants and physical activity at 4-, 8- and 12-months post-randomisation as well as longer term depressive symptoms measured at the 8- and 12-month end-points. 361 patients with a depression diagnosis were recruited from 65 general practices in Bristol and Exeter. Adherence to the intervention was good, with 71 % of those offered the additional treatment receiving an 'adequate dose'. The primary comparative analysis indicated an adjusted between-groups difference in means of -0.54 points (95% CI -3.06 to 1.99; p=0.68) on the Beck Depression Inventory at 4-month follow-up. There was no evidence that the intervention influenced the prescription or use of antidepressants or made any impact on quality of life at any stage. However, there was a significant increase in the amount of physical activity reported by the intervention group (OR = 2.27, 95% CI 1.32 to 3.89; p=0.0003) over the course of the 12-month trial compared to the usual care group. It was clear that adding a facilitated physical activity intervention to usual care did not benefit depression outcomes and that, consequently, it should not be recommended as a treatment option within UK primary care.

Identiferoai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:684366
Date January 2013
CreatorsChalder, Melanie Jane Emma
PublisherUniversity of Bristol
Source SetsEthos UK
Detected LanguageEnglish
TypeElectronic Thesis or Dissertation

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