Abstract：
BACKGROUND: In the treatment of borderline personality disorder (BPD), there is empirical support for both dialectical behavior therapy (DBT) and schema therapy (ST); these treatments have never been compared directly. This study examines whether either of them is more effective than the other in treating patients with BPD.
METHODS: In this randomized, parallel-group, rater-blind clinical trial, outpatients aged between 18 and 65 years with a primary diagnosis of BPD were recruited in a tertiary outpatient treatment center (Lübeck, Germany). Participants were randomized to DBT or ST with one individual and one group session per week over 1.5 years. The primary outcome was the BPD symptom severity assessed with the mean score of the Borderline Personality Disorder Severity Index at 1-year naturalistic follow-up.
RESULTS: Between November 26, 2014, and December 14, 2018, we enrolled 164 patients (mean age = 33.7 [SD = 10.61] years). Of these, 81 (49.4%) were treated with ST and 83 (50.6%) with DBT, overall, 130 (79.3%) were female. Intention-to-treat analysis with generalized linear mixed models did not show a significant difference at 1-year naturalistic follow-up between DBT and ST for the BPDSI total score (mean difference 3.32 [95% CI: -0.58-7.22], p = 0.094, d = -24 [-0.69; 0.20]) with lower scores for DBT. Pre-to-follow-up effect sizes were large in both groups (DBT: d = 2.45 [1.88-3.02], ST: d = 1.78 [1.26-2.29]).
CONCLUSIONS: Patients in both treatment groups showed substantial improvements indicating that even severely affected patients with BPD and various comorbid disorders can be treated successfully with DBT and ST. An additional non-inferiority trial is needed to show if both treatments are equally effective. The trial was retrospectively registered on the German Clinical Trials Register, DRKS00011534 without protocol changes.
METHODS: In this randomized, parallel-group, rater-blind clinical trial, outpatients aged between 18 and 65 years with a primary diagnosis of BPD were recruited in a tertiary outpatient treatment center (Lübeck, Germany). Participants were randomized to DBT or ST with one individual and one group session per week over 1.5 years. The primary outcome was the BPD symptom severity assessed with the mean score of the Borderline Personality Disorder Severity Index at 1-year naturalistic follow-up.
RESULTS: Between November 26, 2014, and December 14, 2018, we enrolled 164 patients (mean age = 33.7 [SD = 10.61] years). Of these, 81 (49.4%) were treated with ST and 83 (50.6%) with DBT, overall, 130 (79.3%) were female. Intention-to-treat analysis with generalized linear mixed models did not show a significant difference at 1-year naturalistic follow-up between DBT and ST for the BPDSI total score (mean difference 3.32 [95% CI: -0.58-7.22], p = 0.094, d = -24 [-0.69; 0.20]) with lower scores for DBT. Pre-to-follow-up effect sizes were large in both groups (DBT: d = 2.45 [1.88-3.02], ST: d = 1.78 [1.26-2.29]).
CONCLUSIONS: Patients in both treatment groups showed substantial improvements indicating that even severely affected patients with BPD and various comorbid disorders can be treated successfully with DBT and ST. An additional non-inferiority trial is needed to show if both treatments are equally effective. The trial was retrospectively registered on the German Clinical Trials Register, DRKS00011534 without protocol changes.
摘要：
背景：在治疗边缘性人格障碍（BPD）中，辩证行为疗法（DBT）和图式疗法（ST）都有经验支持；这些治疗方法从未直接比较。这项研究检查了它们中的任何一个在治疗BPD患者方面是否比另一个更有效。
方法：在本随机分组中，平行组，评估者盲临床试验，在三级门诊治疗中心（吕贝克，德国)。参与者被随机分配到DBT或ST，在1.5年内每周有一个人和一个小组。主要结果是在1年的自然随访中，用边缘性人格障碍严重程度指数的平均得分评估BPD症状严重程度。
结果：在2014年11月26日至2018年12月14日之间，我们招募了164名患者（平均年龄=33.7[SD=10.61]岁）。其中,81例（49.4%）接受ST治疗，83例（50.6%）接受DBT治疗，总的来说,130名（79.3％）为女性。使用广义线性混合模型的意向治疗分析在1年的自然随访中，DBT和ST之间的BPDSI总分没有显着差异（平均差异3.32[95％CI：-0.58-7.22]，p=0.094，d=-24[-0.69;0.20]），DBT得分较低。两组的随访前效果均较大（DBT：d=2.45[1.88-3.02]，ST:d=1.78[1.26-2.29])。
结论：两个治疗组的患者均表现出显著的改善，表明即使患有BPD和各种共病的严重患者也可以用DBT和ST成功治疗。需要额外的非劣效性试验来显示两种治疗方法是否同样有效。该试验在德国临床试验登记册上进行了回顾性注册，DRKS00011534无需更改协议。
方法：在本随机分组中，平行组，评估者盲临床试验，在三级门诊治疗中心（吕贝克，德国)。参与者被随机分配到DBT或ST，在1.5年内每周有一个人和一个小组。主要结果是在1年的自然随访中，用边缘性人格障碍严重程度指数的平均得分评估BPD症状严重程度。
结果：在2014年11月26日至2018年12月14日之间，我们招募了164名患者（平均年龄=33.7[SD=10.61]岁）。其中,81例（49.4%）接受ST治疗，83例（50.6%）接受DBT治疗，总的来说,130名（79.3％）为女性。使用广义线性混合模型的意向治疗分析在1年的自然随访中，DBT和ST之间的BPDSI总分没有显着差异（平均差异3.32[95％CI：-0.58-7.22]，p=0.094，d=-24[-0.69;0.20]），DBT得分较低。两组的随访前效果均较大（DBT：d=2.45[1.88-3.02]，ST:d=1.78[1.26-2.29])。
结论：两个治疗组的患者均表现出显著的改善，表明即使患有BPD和各种共病的严重患者也可以用DBT和ST成功治疗。需要额外的非劣效性试验来显示两种治疗方法是否同样有效。该试验在德国临床试验登记册上进行了回顾性注册，DRKS00011534无需更改协议。
