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

用长期悲伤特异性认知行为疗法（PROGRID）治疗长期悲伤障碍

• 批准号: 286629540
• 负责人: Professorin Dr. Rita Rosner
• 金额: --
• 依托单位: Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/286629540?language=en
• 关键词: Treating; Prolonged; Grief; Disorder; Specific

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.

持续性悲伤障碍（PGD）是一种持续性和致残性的悲伤反应，在一个重要的人死亡后，这将被纳入即将到来的ICD-11。PGD的患病率估计约为5%，合并症发生率较高。认知行为治疗（CBT）已被证明是有效的针对长期的悲伤症状，但较少与次要结果，例如，抑郁症和整体心理健康。我们的初步研究结果表明，特别是躯体形式障碍是令人惊讶的普遍PGD患者，而一个其他高效的悲伤特异性认知行为治疗（PG-CBT）是有效的躯体化。这项随机对照试验将评估PG-CBT增强与一个额外的治疗模块的躯体形式症状相比，支持性对照条件与基本的治疗元素（目前为中心的治疗，PCT）。将204例PGD患者随机分配至PG-CBT或PCT组，以显示两组之间基线和12个月随访期间PG-13严重程度量表平均变化的相关最小临床差异为5. 5分，把握度为80%，α水平为5%。该程序旨在尽可能避免偏倚（分层、盲态结局评估、ITT分析、平衡治疗剂量、忠诚效应控制）。研究结果将推动并为国际和国内制定这种新诊断的治疗指南提供信息。