ABSTRACT

Few studies have examined brief transdiagnostic groups. The Take Control Course (TCC) was developed for patients with mild to moderate common mental health problems. We examined whether TCC is non-inferior to individual low-intensity cognitive behaviour therapy (CBT) in a single-blind individually randomised parallel non-inferiority trial. The primary outcomes were depression (PHQ9) and anxiety (GAD7) at 6-month follow-up (primary outcome point) and 12-month follow-up. The non-inferiority margin that we set, based on previous trials, corresponds to approximately 3 points on the PHQ9 and approximately 2.5 points on the GAD7. Intention-to-treat (ITT) and per-protocol (PP) analyses of 6-month data of 156 randomised patients indicated that TCC was non-inferior to individual low-intensity CBT on anxiety (ITT Coefficient = 0.24; 95% CI: −1.45 to 1.92; d = 0.04; p = .79), and depression (ITT Coefficient = 0.82; 95% CI: −1.06 to 2.69; d = 0.14; p = .39) outcomes, and functioning (ITT Coefficient = 0.69; 95% CI: −2.56 to 3.94; d = 0.08; p = .68). The findings at 12 months were inconclusive and require further testing. This randomised trial provides preliminary support that TCC is not less effective than short-term individual CBT within Improving Access to Psychological Therapies (IAPT) services.

摘要

很少有研究检查过简短的跨诊断组。采取控制课程 (TCC) 是为患有轻度至中度常见心理健康问题的患者开发的。我们在一项单盲、个体随机化平行非劣效性试验中检验了 TCC 是否不劣于个体低强度认知行为疗法 (CBT)。主要结果是 6 个月随访（主要结果点）和 12 个月随访时的抑郁 (PHQ9) 和焦虑 (GAD7)。我们根据之前的试验设定的非劣效性界值对应于 PHQ9 上的大约 3 分和 GAD7 上的大约 2.5 分。对 156 名随机患者的 6 个月数据进行的意向治疗 (ITT) 和符合方案 (PP) 分析表明，TCC 对焦虑的影响不劣于个体低强度 CBT（ITT 系数 = 0.24；95% CI： -1.45 至 1.92；d  = 0.04；p  = .79）和抑郁（ITT 系数 = 0.82；95% CI：-1.06 至 2.69；d  = 0.14；p  = .39）结果和功能（ITT 系数 = 0.69；95% CI：-2.56 至 3.94 ；d  = 0.08；p  = .68）。12 个月时的结果尚无定论，需要进一步测试。这项随机试验提供了初步支持，即 TCC 在改善获得心理治疗 (IAPT) 服务方面的效果不亚于短期个人 CBT。