Schmitt Andreas, Kulzer Bernhard, Reimer André, Herder Christian, Roden Michael, Haak Thomas, Hermanns Norbert
Research Institute of the Diabetes Academy Mergentheim, Diabetes Center Mergentheim, Bad Mergentheim, Germany.
German Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.
Psychother Psychosom. 2022;91(2):107-122. doi: 10.1159/000520319. Epub 2021 Dec 7.
Depression is a common and serious complication of diabetes. Treatment approaches addressing the specific demands of affected patients are scarce.
The aim of this work was to test whether a stepped care approach for patients with diabetes and depression and/or diabetes distress yields greater depression reduction than treatment-as-usual.
Two-hundred and sixty patients with diabetes and elevated depressive symptoms (CES-D ≥16) and/or elevated diabetes distress (PAID ≥40) were randomized to stepped care for depression or diabetes treatment-as-usual. The primary outcome was the rate of meaningful depression reduction at the 12-month follow-up according to the HAMD (score <9 or reduction by ≥50%). Secondary outcomes were changes in depression scores (HAMD/CES-D), diabetes distress (PAID), diabetes acceptance (AADQ), well-being (WHO-5), quality of life (EQ-5D/SF-36), self-care behavior (SDSCA/DSMQ), HbA1c, and biomarkers of inflammation.
One-hundred and thirty-one individuals were assigned to stepped care and 129 to treatment-as-usual. Overall, 15.4% were lost to follow-up. Meaningful depression reduction was observed in 80.2 versus 51.2% in stepped care versus treatment-as-usual (p < 0.001, intention-to-treat analysis). Of the secondary measures, the HAMD (∆ -3.2, p < 0.001), WHO-5 (∆ 1.5, p = 0.007), and AADQ (∆ -1.0, p = 0.008) displayed significant treatment effects, while effects on CES-D (∆ -2.3, p = 0.065), PAID (∆ -3.5, p = 0.109), and SDSCA (∆ 0.20, p = 0.081) were not significantly different. Both groups showed comparable changes in EQ-5D/SF-36, DSMQ, HbA1c, and biomarkers of inflammation (all p ≥ 0.19).
The stepped care approach improved depression, well-being, and acceptance. The results support that increasing treatment intensity on demand is effective and can help provide more optimal treatment. The inclusion of diabetes-specific interventions may be beneficial for patients with diabetes and elevated depression.
抑郁症是糖尿病常见且严重的并发症。针对受影响患者特定需求的治疗方法稀缺。
本研究旨在测试针对糖尿病合并抑郁症和/或糖尿病困扰患者的阶梯式护理方法是否比常规治疗能更有效地减轻抑郁症状。
260例糖尿病患者，其抑郁症状评分（CES-D≥16）和/或糖尿病困扰评分（PAID≥40）升高，被随机分为抑郁症阶梯式护理组或糖尿病常规治疗组。主要结局指标是根据汉密尔顿抑郁量表（HAMD）在12个月随访时抑郁症状显著减轻的比例（评分<9或降低≥50%）。次要结局指标包括抑郁评分（HAMD/CES-D）、糖尿病困扰（PAID）、糖尿病接受度（AADQ）、幸福感（WHO-5）、生活质量（EQ-5D/SF-36）、自我护理行为（SDSCA/DSMQ）、糖化血红蛋白（HbA1c）以及炎症生物标志物的变化。
131人被分配到阶梯式护理组，129人被分配到常规治疗组。总体而言，15.4%的患者失访。在阶梯式护理组和常规治疗组中，分别有80.2%和51.2%的患者抑郁症状显著减轻（p<0.001，意向性分析）。在次要测量指标中，HAMD（差值-3.2，p<0.001）、WHO-5（差值1.5，p=0.007）和AADQ（差值-1.0，p=0.008）显示出显著的治疗效果，而对CES-D（差值-2.3，p=0.065）、PAID（差值-3.5，p=0.109）和SDSCA（差值0.20，p=0.081）的影响无显著差异。两组在EQ-5D/SF-36、DSMQ、HbA1c和炎症生物标志物方面的变化相当（所有p≥0.19）。
阶梯式护理方法改善了抑郁症状、幸福感和接受度。结果表明，按需增加治疗强度是有效的，有助于提供更优化的治疗。纳入针对糖尿病的干预措施可能对糖尿病合并抑郁症状加重的患者有益。
