A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial
A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial
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DOI：
10.3310/hta16100
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发表时间：
2012-03-01
影响因子：
3.6
通讯作者：
Lewis, G.
中科院分区：
文献类型：
--
作者：
Chalder, M.;Wiles, N. J.;Lewis, G.
目的：体力活动治疗抑郁症(TREAD)研究调查了在常规全科医生护理的基础上，体力活动干预作为抑郁症患者治疗方法的成本效益。设计：一项单独随机、实用的多中心随机对照试验，随访时间分别为4个月、8个月和12个月。一部分参与者参与了一项定性研究，调查了干预的可接受性和感知到的好处。单位：布里斯托尔和埃克塞特地区的一般做法。研究对象：年龄18-69岁，符合《国际疾病及相关健康问题统计分类》第10版(ICD-10)抑郁症诊断标准，Beck抑郁量表(BDI)评分=14分。那些不能完成英语自填式问卷、有体力活动医学禁忌症或患有精神病、躁郁症或严重药物滥用的人被排除在外。干预措施：我们设计了一种干预措施，旨在鼓励选择和自主采用体力活动。它包括由一名训练有素的体力活动促进员在8个月内提供多达3次面对面接触和10次电话联系。主要观察指标：主要结果是在4个月时测量的BDI评分。次要结果包括12个月内的抑郁症状和生活质量、抗抑郁药物的使用和体力活动水平。结果：这项研究招募了361名患者，其中182人被随机分配到干预组，179人被随机分配到常规护理组；在4个月的随访中，80%的患者保留了下来。干预组在4个月时BDI评分略低[-0.54，95%可信区间(CI)-3.06至1.99]，但没有证据表明干预改善了抑郁的结局。也没有任何证据表明抗抑郁药的处方或自我报告的使用情况有所不同。然而，接受干预的人的体力活动量增加了(优势比2.3，95%可信区间1.3比3.9)，并持续到干预结束后。从卫生保健的角度来看，干预组比常规护理组的费用更高，干预费用平均为每人220英镑。因此，按照目前的支付意愿阈值，这种干预作为一种治疗抑郁症的成本效益极低的方法是极不可能的。结论：就抑郁症状而言，这种体力活动干预不太可能带来任何临床益处，也不太可能成为一种经济有效的抑郁症治疗方法。之前的研究已经报告了一些好处，这种差异可能有三个原因：第一，尽管干预增加了自我报告的体力活动，但活动增加的幅度还不够大，不足以产生可测量的影响；第二，只有更剧烈的活动才可能有益；第三，之前的研究招募了先前对体育活动有承诺的人。未来的研究需要确定和解释抑郁症可能被有效治疗的机制，特别是关于产生治疗效果所需的最佳体力活动类型、强度和持续时间的具体指导。
Objective: The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. Design: An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. Setting: General practices in the Bristol and Exeter areas. Participants: Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring >= 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. Interventions: We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. Main outcome measures: The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. Results: The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (Cl) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention 220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. Conclusions: This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect.