University of Exeter Medical School, St Luke's Campus, Exeter, UK.
Psychological Therapy, Tees, Esk & Wear Valleys NHS Foundation Trust, County Durham, UK.
Health Technol Assess. 2017 Aug;21(46):1-366. doi: 10.3310/hta21460.
BACKGROUND: Depression is a common, debilitating and costly disorder. The best-evidenced psychological therapy - cognitive-behavioural therapy (CBT) - is complex and costly. A simpler therapy, behavioural activation (BA), may be an effective alternative. OBJECTIVES: To determine the clinical effectiveness and cost-effectiveness of BA compared with CBT for depressed adults at 12 and 18 months' follow-up, and to investigate the processes of treatments. DESIGN: Randomised controlled, non-inferiority trial stratified by depression severity, antidepressant use and recruitment site, with embedded process evaluation; and randomisation by remote computer-generated allocation. SETTING: Three community mental health services in England. PARTICIPANTS: Adults aged ≥ 18 years with major depressive disorder (MDD) recruited from primary care and psychological therapy services. INTERVENTIONS: BA delivered by NHS junior mental health workers (MHWs); CBT by NHS psychological therapists. OUTCOMES: Primary: depression severity (as measured via the Patient Health Questionnaire-9; PHQ-9) at 12 months. Secondary: MDD status; number of depression-free days; anxiety (as measured via the Generalised Anxiety Disorder-7); health-related quality of life (as measured via the Short Form questionnaire-36 items) at 6, 12 and 18 months; and PHQ-9 at 6 and 18 months, all collected by assessors blinded to treatment allocation. Non-inferiority margin was 1.9 PHQ-9 points. We undertook intention-to-treat (ITT) and per protocol (PP) analyses. We explored cost-effectiveness by collecting direct treatment and other health- and social-care costs and calculating quality-adjusted life-years (QALYs) using the EuroQol-5 Dimensions, three-level version, at 18 months. RESULTS: We recruited 440 participants (BA, = 221; CBT, = 219); 175 (79%) BA and 189 (86%) CBT participants provided ITT data and 135 (61%) BA and 151 (69%) CBT participants provided PP data. At 12 months we found that BA was non-inferior to CBT {ITT: CBT 8.4 PHQ-9 points [standard deviation (SD) 7.5 PHQ-9 points], BA 8.4 PHQ-9 points (SD 7.0 PHQ-9 points), mean difference 0.1 PHQ-9 points, 95% confidence interval (CI) -1.3 to 1.5 PHQ-9 points, = 0.89; PP: CBT 7.9 PHQ-9 points (SD 7.3 PHQ-9 points), BA 7.8 PHQ-9 points (SD 6.5 PHQ-9 points), mean difference 0.0 PHQ-9 points, 95% CI -1.5 to 1.6 PHQ-9 points, = 0.99}. We found no differences in secondary outcomes. We found a significant difference in mean intervention costs (BA, £975; CBT, £1235; < 0.001), but no differences in non-intervention (hospital, community health, social care and medication costs) or total (non-intervention plus intervention) costs. Costs were lower and QALY outcomes better in the BA group, generating an incremental cost-effectiveness ratio of -£6865. The probability of BA being cost-effective compared with CBT was almost 80% at the National Institute for Health and Care Excellence's preferred willingness-to-pay threshold of £20,000-30,000 per QALY. There were no trial-related adverse events. LIMITATIONS: In this pragmatic trial many depressed participants in both groups were also taking antidepressant medication, although most had been doing so for a considerable time before entering the trial. Around one-third of participants chose not to complete a PP dose of treatment, a finding common in both psychotherapy trials and routine practice. CONCLUSIONS: We found that BA is as effective as CBT, more cost-effective and can be delivered by MHWs with no professional training in psychological therapies. FUTURE WORK: Settings and countries with a paucity of professionally qualified psychological therapists, might choose to investigate the delivery of effective psychological therapy for depression without the need to develop an extensive and costly professional infrastructure. TRIAL REGISTRATION: Current Controlled Trials ISRCTN27473954. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 21, No. 46. See the NIHR Journals Library website for further project information.
背景：抑郁症是一种常见的、使人衰弱且代价高昂的疾病。最有证据支持的心理疗法——认知行为疗法（CBT）——比较复杂且费用高昂。一种更简单的疗法，行为激活（BA），可能是一种有效的替代疗法。
目的：在 12 个月和 18 个月的随访中，比较 BA 与 CBT 对抑郁成年患者的临床疗效和成本效益，并调查治疗过程。
设计：这是一项随机对照、非劣效性试验，按抑郁严重程度、抗抑郁药物使用情况和招募地点分层，同时进行嵌入式过程评估；并通过远程计算机生成的分配进行随机分组。
地点：英格兰的三个社区心理健康服务机构。
参与者：从初级保健和心理治疗服务中招募的年龄≥18 岁、患有主要抑郁症（MDD）的成年人。
干预措施：由 NHS 初级心理健康工作者（MHWs）提供 BA；由 NHS 心理治疗师提供 CBT。
结局：主要结局：12 个月时的抑郁严重程度（采用患者健康问卷-9 量表（PHQ-9）进行测量）。次要结局：MDD 状态；无抑郁天数；焦虑（采用广泛性焦虑障碍-7 量表进行测量）；健康相关生活质量（采用 36 项简短问卷进行测量），分别在 6、12 和 18 个月进行评估；以及 18 个月时的 PHQ-9，所有评估均由对治疗分配不知情的评估者进行。非劣效性边界为 1.9 个 PHQ-9 分。我们进行了意向治疗（ITT）和符合方案（PP）分析。我们通过收集直接治疗和其他健康和社会保健费用，并使用欧洲五维健康量表（EQ-5D）在 18 个月时计算质量调整生命年（QALY），来探索成本效益。
结果：我们招募了 440 名参与者（BA， = 221；CBT， = 219）；175 名（79%）BA 和 189 名（86%）CBT 参与者提供了 ITT 数据，135 名（61%）BA 和 151 名（69%）CBT 参与者提供了 PP 数据。在 12 个月时，我们发现 BA 不劣于 CBT{ITT：CBT 的 PHQ-9 评分为 8.4 分[标准偏差（SD）为 7.5 分]，BA 的 PHQ-9 评分为 8.4 分[SD 为 7.0 分]，平均差异为 0.1 分，95%置信区间（CI）为-1.3 至 1.5 分， = 0.89；PP：CBT 的 PHQ-9 评分为 7.9 分[SD 为 7.3 分]，BA 的 PHQ-9 评分为 7.8 分[SD 为 6.5 分]，平均差异为 0.0 分，95%CI 为-1.5 至 1.6 分， = 0.99}。我们没有发现次要结局的差异。我们发现干预的平均成本存在显著差异（BA，£975；CBT，£1235； < 0.001），但非干预（医院、社区卫生、社会保健和药物治疗）或总（非干预加干预）成本没有差异。BA 组的干预成本较低，QALY 结果较好，产生了增量成本效益比为-£6865。在国家卫生与保健卓越研究所（NICE）首选的 20000-30000 英镑/QALY 支付意愿阈值下，BA 与 CBT 相比具有成本效益的可能性几乎为 80%。试验没有相关不良事件。
局限性：在这项实用的试验中，两组中有许多抑郁的参与者也在服用抗抑郁药物，尽管他们大多数人在进入试验前已经服用了相当长一段时间的药物。大约三分之一的参与者选择不完成 PP 剂量的治疗，这在心理治疗试验和常规实践中都很常见。
结论：我们发现 BA 与 CBT 一样有效，更具成本效益，并且可以由没有接受过心理治疗专业培训的初级心理健康工作者提供。
未来工作：在缺乏专业合格心理治疗师的环境和国家，可能会选择调查不依赖于发展广泛而昂贵的专业基础设施，就能提供有效的心理治疗来治疗抑郁症。
试验注册：当前对照试验 ISRCTN27473954。
资金：该项目由英国国家卫生研究院（NIHR）卫生技术评估计划资助，将在；第 21 卷，第 46 期。请访问 NIHR 期刊库网站以获取更多项目信息。
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