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

长期悲伤障碍（PGD）是在重要的另一半去世后持续的、致残的悲伤反应，它将被列入即将到来的ICD-11。PGD的患病率估计约为5%，并伴有较高的合并症。认知行为治疗（CBT）已被证明对长期悲伤症状有效，但对次要结果（如抑郁和整体心理健康）效果较差。我们的初步研究结果显示，躯体形式的疾病在PGD患者中尤为普遍，而原本非常有效的悲伤特异性认知行为治疗（PG-CBT）在躯体化方面效果较差。这一随机对照试验将评估PG-CBT与基于基本治疗元素（以现在为中心的治疗，PCT）的支持性对照条件相比，在附加治疗模块的基础上增强的躯体症状治疗模块。204名PGD患者将被随机分配到PG-CBT或PCT组，以显示两组在基线和12个月随访期间PG-13严重程度量表平均变化5.5分的相关最小临床差异，功率为80%，α水平为5%。该程序旨在尽可能避免偏倚（分层、盲结果评估、ITT分析、平衡治疗剂量、忠诚效应控制）。研究结果将在国际和国内推动并为这一新诊断的治疗指南的制定提供信息。

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.