Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD

创伤知情内疚减轻疗法 (TrIGR) 治疗 PTSD 的非劣效性试验

• 批准号: 10584430
• 负责人: SONYA NORMAN
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584430
• 关键词: Afghanistan; Aftercare; Clinic; Clinical; Cognitive; Diagnosis; Disease; Distress; Dropout; Emotions; Enrollment; Exclusion Criteria; Feeling suicidal; Guilt; Healthcare Systems; Impairment; Intervention; Iraq; Learning; Mediating; Mental Depression; Mental Health; Mental Health Services; Outcome; Persons; Phase; Post-Traumatic Stress Disorders; Protocols documentation; Psychopathology; Randomized; Reporting; Resources; Role; Severities; Shame; Site; Supportive care; Survivors; Symptoms; Trauma; Treatment outcome; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; Work; arm; brief intervention; cost; depressive symptoms; efficacy study; evidence base; experience; improved; psychosocial; randomized, clinical trials; reduce symptoms; response; suicidal risk; trauma exposure; traumatic event

Trauma-related guilt is common and impairing among trauma survivors, particularly among treatment seeking Veterans with posttraumatic stress disorder (PTSD). Guilt is a distressing emotion that arises when trauma survivors blame themselves for the outcome of a traumatic event and guilt turns to shame when people judge not just their actions but themselves negatively because of what happened. Guilt is positively associated with severity of PTSD and depression symptoms, suicidal ideation, poorer psychosocial functioning, and shame. Among those with PTSD, guilt is one of the symptoms likely to persist after PTSD treatment, suggesting further intervention targeting guilt is needed. Although evidence-based trauma-focused PTSD treatments such as Cognitive Processing Therapy (CPT) are effective to treat PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment, and dropout from these generally 12+ session protocols is high. Veterans show lower response and higher dropout than others with PTSD. Delivering protocols that are generally 12 or more sessions challenges the Veterans Affairs (VA) healthcare system given high demand for mental health care. For these reasons, additional and less burdensome approaches are needed. Brief treatment that targets mechanisms that are distressing and associated with multiple problems and disorders may be an understudied but promising way to treat PTSD and other posttraumatic psychopathology. Our work shows that a brief treatment targeting trauma-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with activities they find meaningful. In a preliminary efficacy study with 144 OEF/OIF/OND Veterans with guilt from a deployment trauma, we found large effects in PTSD symptom reduction and moderate effects in depression symptom reduction in TrIGR compared to supportive therapy. More than 50% lost their PTSD diagnosis and two thirds showed clinically meaningful change. Dropout was low and attendance was high - Veterans attended more than five of six sessions on average. Whether TrIGR is no less effective than longer, more resource heavy evidence-based PTSD treatments disseminated across by VA, like CPT, is the next critical question. The proposed randomized clinical trial (RCT) will be the first non-inferiority trial of TrIGR and the first to compare TrIGR to a first tier PTSD treatment, specifically CPT. It will also be the first to evaluate TrIGR with Veterans from all eras with guilt from any type of traumas, as our previous work was exclusively with Veterans of the conflicts in Iraq and Afghanistan with deployment-related traumas. 158 Veterans across two VA sites will be randomized to TrIGR or CPT. Exclusion criteria will be minimal so that generalizability will be high. Treatment will be delivered in VA mental health clinics. The primary aim is to evaluate if TrIGR is non-inferior to CPT in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate TrIGR’s non-inferiority relative to CPT regarding depression severity. We will explore potential mechanisms of treatment, such as the relationship between change in guilt and shame change in PTSD symptoms and the role of inhibitory learning in treatment outcomes. We will also examine differential dropout and change in suicidal ideation and psychosocial functioning. The proposed study is critical to establish whether TrIGR is effective for a much larger group of Veterans and whether it is as effective as longer treatments already available in VA to inform if TrIGR warrants further study and dissemination in VA.

与创伤相关的内疚感在创伤幸存者中很常见，并且会造成损害，特别是在寻求治疗的人中 患有创伤后应激障碍（PTSD）的退伍军人在遭受创伤时会产生一种令人痛苦的情绪。 幸存者将创伤事件的结果归咎于自己，而当人们做出评判时，内疚就会变成羞耻 不仅是他们的行为，而且他们自己也因为所发生的事情而产生负面影响。 创伤后应激障碍（PTSD）和抑郁症状的严重程度、自杀意念、较差的社会心理功能和羞耻感。 在患有 PTSD 的人中，内疚是 PTSD 治疗后可能持续存在的症状之一，这进一步表明 需要针对内疚感进行干预。 尽管认知加工疗法 (CPT) 等基于证据的创伤后应激障碍 (PTSD) 治疗方法 有效治疗创伤后应激障碍和创伤相关的内疚感，许多人仍然出现症状或维持诊断 治疗后，退伍军人从这些通常 12 次以上的治疗方案中退出的比例较低。 与其他患有 PTSD 的人相比，他们的反应和辍学率更高，交付的协议通常为 12 或更多。 鉴于对心理健康护理的高需求，会议对退伍军人事务部 (VA) 的医疗保健系统提出了挑战。 由于这些原因，需要额外的、负担较轻的针对性治疗方法。 令人痛苦并与多种问题和疾病相关的机制可能尚未得到充分研究 但治疗 PTSD 和其他创伤后精神病理学的有希望的方法我们的工作表明了这一点。 针对创伤相关内疚和羞耻的治疗，创伤知情内疚减少疗法（TrIGR），可以 减少退伍军人的内疚、创伤后应激障碍、抑郁和痛苦，并帮助他们重新参与他们发现的活动 在一项对 144 名因部署而感到内疚的 OEF/OIF/OND 退伍军人进行的初步功效研究中，这一结果很有意义。 创伤，我们发现对减轻 PTSD 症状有很大影响，对抑郁症状有中等影响 与支持治疗相比，TrIGR 减少 超过 50% 的人失去了 PTSD 诊断，三分之二的人失去了 PTSD 诊断。 显示出具有临床意义的变化，辍学率低，出勤率高——退伍军人出勤率更高。 TrIGR 的效果是否不亚于更长、资源消耗更大的 VA 推广的循证 PTSD 治疗方法（如 CPT）是下一个关键问题。 拟议的随机临床试验（RCT）将是 TrIGR 的第一个非劣效性试验，也是第一个 将 TrIGR 与一级 PTSD 治疗（特别是 CPT）进行比较 这也将是第一个用 TrIGR 进行评估的治疗。 来自各个时代的退伍军人，因任何类型的创伤而感到内疚，因为我们之前的工作专门针对退伍军人 伊拉克和阿富汗冲突以及与部署相关的创伤将在两个退伍军人事务部驻地的 158 名退伍军人中进行。 被随机分配到 TrIGR 或 CPT 的排除标准将是最小的，因此普遍性将很高。 治疗将在 VA 心理健康诊所进行，主要目的是评估 TrIGR 是否不劣于。 CPT 可以减轻患有 PTSD 的退伍军人的 PTSD 症状严重程度，这些退伍军人支持与创伤相关的内疚感。 次要目标是评估 TrIGR 在抑郁严重程度方面相对于 CPT 的非劣效性。 探索潜在的治疗机制，例如内疚感和羞耻感变化之间的关系 我们还将研究 PTSD 症状的变化以及抑制性学习在治疗结果中的作用。 自杀意念和心理社会功能的差异退出和变化这项研究至关重要。 确定 TrIGR 是否对更多的退伍军人有效，以及它是否与 VA 中已有的治疗方法，以告知 TrIGR 是否值得在 VA 进行进一步研究和传播。