Treating Prolonged Grief Disorder with Prolonged Grief-Specific Cognitive-Behavioural Therapy (PROGRID)

长期悲痛障碍(PGD)是在重要的另一半去世后的一种持续性和致残性的悲痛反应，这将包括在即将到来的ICD-11中。据估计，PGD的患病率约为5%，并有很高的共患率。认知行为治疗(CBT)已被证明在治疗长期悲伤症状方面有效，但对次级结果，如抑郁症和整体心理健康则不太有效。我们的初步研究结果显示，躯体形式障碍在PGD患者中尤其普遍，而其他高效的悲痛特定认知行为治疗(PG-CBT)在躯体化方面效果较差。这项随机对照试验将评估PG-CBT与支持性对照条件(目前中心治疗，PCT)的比较，其中PG-CBT增强了一个治疗躯体症状的治疗模块。204名PGD患者将被随机分为PG-CBT组或PCT组，在基线和12个月的随访期间，PG-13严重程度量表的平均临床变化相关的最小临床差异为5.5分，功率为80%，α水平为5%。该程序旨在尽可能避免偏见(分层、盲目结果评估、ITT分析、平衡治疗剂量、效忠效应控制)。结果将推动和指导国际和国家这一新诊断的治疗指南的制定。

Prolonged grief disorder (PGD) is a persistent and disabling grief reaction following the death of a significant other, which will be included in the upcoming ICD-11. The prevalence of PGD is estimated to be around 5%, with high comorbidity rates. Cognitive behavioural treatment (CBT) has been shown to be effective in targeting prolonged grief symptoms, but less so with secondary outcomes, e.g., depression and overall mental health. Results of our pilot study showed that somatoform disorders in particular were surprisingly prevalent in PGD patients, and that an otherwise highly effective grief-specific cognitive behavioural treatment (PG-CBT) was less effective in somatization. This randomized controlled trial will evaluate PG-CBT enhanced with an additional treatment module for somatoform symptoms in comparison to a supportive control condition with basic therapeutic elements (Present-Centered Therapy, PCT). 204 PGD patients will be randomized to either PG-CBT or PCT to show a relevant minimal clinical difference of 5.5 points in mean change at the PG-13 severity scale between baseline and 12 month follow-up between the groups, with a power of 80%, alpha level of 5%. The procedure is designed to avoid bias as much as possible (stratification, blind outcome assessment, ITT analysis, balanced treatment dose, control for allegiance effects). Results will advance and inform the development of treatment guidelines for this new diagnosis internationally as well as nationally.