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.

与创伤有关 病后应激障碍（PTSD）的退伍军人。内gui是一种令人痛苦的情感，当创伤时会产生 幸存者将自己的创伤事件的结果归咎于自己，当人们判断时，内gui又动摇了 不仅是他们的行为，而且由于发生了什么而产生负面影响。内gui与 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的患者中，内gui是PTSD治疗后可能持续存在的症状之一，表明进一步 需要进行干预目标有罪。 尽管以循证创伤为重点的PTSD治疗（例如认知处理疗法（CPT））是 有效治疗PTSD和与创伤有关的内gui，许多人仍然患有症状或保持诊断 治疗后，这些通常12多个会话方案的辍学率很高。退伍军人显示较低 与PTSD相比，响应和辍学更高。提供通常12或更多的协议 对于精神保健的需求很高，会议对退伍军人事务（VA）医疗保健系统提出了挑战。 由于这些原因，需要其他繁重的方法。靶向的简短处理 令人痛苦且与多种问题和疾病相关的机制可能是一种理解 但是治疗PTSD和其他创伤后心理病理学的有前途的方法。我们的工作表明了一个简短的 针对创伤相关的罪恶感和休克，创伤知情的罪恶感疗法（TRIGR）的治疗方法，可以 减少退伍军人中的内gui，PTSD，抑郁和困扰，并帮助他们重新参与他们发现的活动 有意义。在对144个OEF/OIF/OND退伍军人的初步效率研究中，部署感到内gui 创伤，我们发现PTSD症状减轻和抑郁症状中等影响 与支持疗法相比，TrigR的减少。超过50％的人失去了PTSD诊断和三分之二 显示出临床意义的变化。辍学率很低，出勤率很高 - 退伍军人参加了更多 平均六个会议中的五个。 Trigr是否效率不如更长，资源更大 下一个关键问题是由VA（例如CPT）散布的循证PTSD处理。 拟议的随机临床试验（RCT）将是Trigr的第一个非效率试验，第一个试验 将TRIGR与第一个层PTSD治疗，特别是CPT进行比较。这也将是第一个评估trigr的人 来自任何类型的创伤的所有时代的退伍军人，因为我们以前的工作专门与退伍军人一起 在伊拉克和阿富汗的冲突中，与部署相关的创伤。 158名VA站点的退伍军人将 被随机分为Trigr或CPT。排除标准将是最小的，因此概括性将很高。 治疗将在VA心理健康诊所进行。主要目的是评估Trigr是否不在 CPT与PTSD的退伍军人减少了PTSD症状严重程度，他们认可与创伤相关的内gui。 次要目的是评估TrigR相对于CPT在抑郁严重程度方面的不劣效率。我们将 探索治疗的潜在机制，例如有罪和羞耻的变化之间的关系 PTSD症状的变化和抑制性学习在治疗结果中的作用。我们还将检查 自杀念头和社会心理功能的差异辍学和变化。拟议的研究至关重要 确定Trigr是否对更大的退伍军人有效，以及它是否像 VA中已经可以使用的更长的治疗方法通知Trigr是否需要进一步研究和传播VA。