Data from: Third wave cognitive therapy versus mentalization-based treatment for major depressive disorder: a randomised clinical trial

Objective: To compare the benefits and harms of third-wave cognitive
therapy versus mentalisation-based therapy in a small sample of depressed
participants. Setting: The trial was conducted at an outpatient
psychiatric clinic for non-psychotic patients in Roskilde, Denmark.
Participants: 44 consecutive adult participants diagnosed with major
depressive disorder. Interventions: 18 weeks of third-wave cognitive
therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22).
Outcomes: The primary outcome was the Hamilton Rating Scale for Depression
(HDRS) at end of treatment (18 weeks). Secondary outcomes were: remission
(HDRS <8), Beck's Depression Inventory, Symptom Checklist 90
Revised and The WHO-Five Well-being Index 1999. Results: The trial
inclusion lasted for about 2 years as planned but only 44 out of the
planned 84 participants were randomised. Two mentalisation-based
participants were lost to follow-up. The unadjusted analysis showed that
third-wave participants compared with mentalisation-based participants did
not differ significantly regarding the 18 weeks HDRS score (12.9 vs 17.0;
mean difference −4.14; 95% CI −8.30 to 0.03; p=0.051). In the analysis
adjusted for baseline HDRS score, the difference was favouring third-wave
cognitive therapy (p=0.039). At 18 weeks, five of the third-wave
participants (22.7%) were in remission versus none of the
mentalisation-based participants (p=0.049). We recorded no suicide
attempts or suicides during the intervention period in any of the 44
participants. No significant differences were found between the two
intervention groups on the remaining secondary outcomes. Conclusions:
Third-wave cognitive therapy may be more effective than
mentalisation-based therapy for depressive symptoms measured on the HDRS.
However, more randomised clinical trials are needed to assess the effects
of third-wave cognitive therapy and mentalisation-based treatment for
depression. Trial registration number: Registered with Clinical Trials
government identifier: NCT01070134.

研究目的：在小样本抑郁患者中比较第三波认知疗法（third-wave cognitive therapy）与心理化基础疗法（mentalisation-based therapy）的获益与风险。

研究场景：本试验在丹麦罗斯基勒一家针对非精神病性患者的精神科门诊开展。

研究对象：连续纳入的44名成年重度抑郁症（major depressive disorder）患者。

干预措施：22名患者接受18周第三波认知疗法，22名患者接受18周心理化基础治疗（mentalisation-based treatment）。

结局指标：主要结局指标为治疗结束时（18周）的汉密尔顿抑郁量表（Hamilton Rating Scale for Depression, HDRS）评分。次要结局指标包括：缓解（HDRS评分＜8）、贝克抑郁量表（Beck's Depression Inventory）评分、症状自评量表修订版（Symptom Checklist 90 Revised）评分及世界卫生组织五项幸福感指数1999版（WHO-Five Well-being Index 1999）评分。

研究结果：试验入组时长与计划一致（约2年），但计划纳入的84名参与者中仅44名完成随机化。2名接受心理化基础治疗的参与者失访。未调整分析显示，两组18周时的HDRS评分无显著差异（第三波认知疗法组12.9 vs 心理化基础治疗组17.0；均值差-4.14；95%置信区间-8.30至0.03；p=0.051）。经基线HDRS评分调整后，差异倾向于第三波认知疗法组（p=0.039）。18周时，第三波认知疗法组22.7%（5/22）的参与者达到缓解，而心理化基础治疗组无缓解案例（p=0.049）。干预期间44名参与者均未发生自杀企图或自杀事件。两组在其余次要结局指标上无显著差异。

结论：以HDRS评分衡量，第三波认知疗法对抑郁症状的疗效可能优于心理化基础疗法。然而，仍需更多随机临床试验评估第三波认知疗法与心理化基础治疗对抑郁症的疗效。

试验注册编号：美国临床试验数据库（Clinical Trials.gov）注册号：NCT01070134。