Department of Psychiatry and Psychotherapy, University of Cologne, Faculty of Medicine and University Hospital Cologne, Kerpener Straße 62, 50931, Cologne, Germany.
Max-Planck-Institute for Metabolism Research, Gleueler Str 50, 50931, Cologne, Germany.
BMC Psychiatry. 2019 Dec 27;19(1):423. doi: 10.1186/s12888-019-2412-0.
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.
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.
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.
ClinicalTrials.gov (NCT03735576, registered on 24 October 2018); DRKS (DRKS00013769, registered on 28 June 2018).
老年期抑郁症（LLD）是老年人中最常见的精神障碍之一。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 的大多数治疗选择效果较差。由于老年人的特殊心理状况和较低的副作用风险，心理治疗可能对 LLD 特别有益。尽管认知行为疗法（CBT）在年轻人和中年人的抑郁症中得到了高度确立和有效应用，但在 LLD 中，关于 CBT 的小型研究数量有限。在多中心试验中，尚未将针对 LLD 的 CBT 与积极但非特异性的支持性心理干预进行比较。
在这里，我们介绍了 CBTlate 试验的设计，这是一项多中心、随机、观察者设盲、活性对照、平行组试验。CBTlate 的目的是在德国的 7 个地点纳入 248 名患有 LLD 的男性和女性患者。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，15 节专门针对 LLD 的个体化 CBT 治疗在减轻抑郁症状方面更有效。该干预包括 8 周的每周两次个体治疗课程和随机分组后 6 个月的随访期。主要终点是治疗结束时自我报告的 30 项老年抑郁量表（GDS）评估的抑郁严重程度。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用于重性抑郁障碍的患者报告结局工具评估的抑郁症状变化，以及从基线到治疗结束和随访结束时的焦虑症状、睡眠、认知、生活质量和整体健康状况。附加协议包括 MRI 和血液样本采集。
这是第一项比较专科环境中特定 CBT 干预与非特异性支持性心理干预治疗 LLD 的多中心试验。它对开发和实施针对 LLD 的有效心理治疗策略具有重要意义，可能是拓宽 LLD 患者治疗选择的重要一步。
ClinicalTrials.gov（NCT03735576，于 2018 年 10 月 24 日注册）；DRKS（DRKS00013769，于 2018 年 6 月 28 日注册）。
