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Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms

机译:耐火性抑郁 - 彻底打开辩证行为治疗的机制和有效性(REFRADED):对随机试验的调查结果对益处和危害

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Background Individuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression. Aims To compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627). Method RO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated. Results After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI -2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI -2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group. Conclusions The RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.
机译:背景下抑郁症的个体常常不响应药物或心理治疗。完全开放的辩证行为治疗(RO DBT)是一种靶向过度控制的新治疗,难以抑郁症。旨在将Ro DBT加上常用(TAU)与TAU(试验登记:ISRCTN 85784627)进行耐火抑郁症进行比较。方法RO DBT包含29个治疗课程和27个技能课程超过6个月。我们已完成的随机试验评估了三个英国中学中心18个月以上的耐火抑郁症的RO DBT。在250名成年参与者中,我们将162名(65%)随机分配给RO DBT。主要结果是抑郁症(HRSD)的汉密尔顿评级规模,通过分配的治疗评估并分析并分析。结果7个月后,治疗后立即,RO DBT相对于TAU的HRSD抑郁症状明显减少了5.40点(95%CI 0.94-9.85)。 12个月后(初级终点),HRSD的2.15点的差异有利于RO DBT不显着(95%CI -2.28至6.59); HRSD的18个月也不是1.69点(95%CI -2.84至6.22)。在整个RB DBT参与者报告的心理柔韧性和情感应对的比例方面都比对照。然而,与对照组中没有,他们报告了8种可能的严重不良反应。结论RO DBT组报告的HRSD分数明显低于对照组7个月后,但其后不是。严重不良反应的不平衡可能是因为控制有限的报告这些机会。

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