BACKGROUND Late-life depression (LLD) is one of the most prevalent mental disorders in old age. It is associated with various adverse outcomes and frequent use of health care services thereby remaining a serious public health concern. Compared with depression in early adulthood, most treatment options of LLD are less effective. Psychotherapy may be particularly beneficial for LLD due to specific psychological conditions in old age and a low risk of side effects. Although cognitive behavioural therapy (CBT) is highly established and effective in depression in young and mid-life there is only a limited number of small studies on CBT in LLD. An LLD-specific CBT has not yet been compared to an active, but unspecific supportive psychological intervention in a multicentre trial. METHODS Here we present the design of the CBTlate trial, which is a multicentre, randomized, observer-blinded, active-controlled, parallel group trial. CBTlate aims at including 248 patients with LLD of both genders at 7 sites in Germany. The purpose of the study is to test the hypothesis that a 15-session individually-delivered CBT specific for LLD is of superior efficacy in reducing symptoms of depression in comparison with a supportive unspecific intervention (SUI) of the same quantity. The intervention includes 8 weeks of individual treatment sessions twice per week and a follow-up period of 6 months after randomization. The primary end point is the severity of depression at the end of treatment measured by the self-rated 30-item Geriatric Depression Scale (GDS). Secondary endpoints include depressive symptoms at week 5 and at follow-up (6 months after randomization). Additional secondary endpoints include the change of depressive symptoms assessed with a clinician-rating-scale and a patient reported outcome instrument for major depressive disorder, anxiety symptoms, sleep, cognition, quality of life, and overall health status from baseline to end-of treatment and to end of follow-up. Add-on protocols include MRI and the collection of blood samples. DISCUSSION This study is the first multicentre trial of a specific CBT intervention for LLD compared to an unspecific supportive psychological intervention administered in a specialist setting. It has important implications for developing and implementing efficient psychotherapeutic strategies for LLD and may be a significant step to broaden treatment options for people suffering from LLD. TRIAL REGISTRATION ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).

中文翻译：

---

治疗晚年抑郁症的认知行为疗法：多中心、随机、观察者盲法对照试验（CBTlate）的研究方案。

背景晚年抑郁症（LLD）是老年时期最普遍的精神障碍之一。它与各种不良后果和频繁使用医疗保健服务有关，因此仍然是一个严重的公共卫生问题。与成年早期的抑郁症相比，LLD 的大多数治疗方案效果较差。由于老年时的特定心理状况和副作用风险较低，心理治疗可能对 LLD 特别有益。尽管认知行为疗法 (CBT) 在治疗青年和中年抑郁症方面已得到高度认可且有效，但针对 LLD 中 CBT 的小型研究数量有限。尚未在多中心试验中将 LLD 特异性 CBT 与积极但非特异性的支持性心理干预进行比较。方法在这里，我们介绍 CBTlate 试验的设计，这是一项多中心、随机、观察者盲法、主动对照、平行组试验。CBTlate 旨在纳入德国 7 个地点的 248 名男女 LLD 患者。该研究的目的是检验以下假设：与相同数量的支持性非特异性干预 (SUI) 相比，针对 LLD 的 15 次单独实施的 CBT 在减轻抑郁症状方面具有更佳的功效。干预措施包括每周两次为期 8 周的个体治疗，以及随机分组后 6 个月的随访期。主要终点是治疗结束时通过自评 30 项老年抑郁量表 (GDS) 测量的抑郁严重程度。次要终点包括第 5 周和随访时（随机分组后 6 个月）的抑郁症状。其他次要终点包括使用临床医生评定量表和患者报告的重度抑郁症结果工具评估的抑郁症状变化、焦虑症状、睡眠、认知、生活质量和从基线到治疗结束的整体健康状况并结束随访。附加方案包括 MRI 和血样采集。讨论 本研究是第一个针对 LLD 的特定 CBT 干预与在专家环境中实施的非特定支持性心理干预进行比较的多中心试验。它对于制定和实施有效的 LLD 心理治疗策略具有重要意义，并且可能是扩大 LLD 患者治疗选择的重要一步。试验注册 ClinicalTrials.gov（NCT03735576，于 2018 年 10 月 24 日注册）；DRKS（DRKS00013769，注册于2018年6月28日）。