Powers Mark B, Douglas Megan E, Driver Simon, Sikka Seema, Hamilton Rita, Swank Chad, Callender Librada, Ochoa Christa, Bennett Monica, Stewart Neil, Chauvin Gregory V, Rothbaum Barbara O, Warren Ann Marie
Baylor Scott & White Spinal Cord Injury Model System, USA.
Baylor Scott and White Research Institute, Dallas, TX, USA.
Contemp Clin Trials Commun. 2022 Nov 11;30:101030. doi: 10.1016/j.conctc.2022.101030. eCollection 2022 Dec.
Scant research has focused on posttraumatic stress disorder (PTSD) in the SCI population, despite high prevalence estimates. Fortunately, prolonged exposure therapy (PE) is a well-researched and highly effective treatment for PTSD. Our recent clinical trial showed that standard 12-session PE was effective for PTSD treatment among inpatients with SCI. Early intervention with brief PE (3-sessions) delivered in the emergency department has also been effective for PTSD prevention, but has not been tested among people post-SCI. Thus, we aim to conduct the first test of the Brief PE intervention to prevent PTSD among patients with SCI.
Adults who have experienced a SCI (N = 200) will be randomly assigned during inpatient rehabilitation to either: (a) 3 60-min sessions of Brief PE (intervention group) or (b) treatment as usual (control group).
The primary outcome measure (PTSD symptoms measured by the PSSI-5) and secondary outcome measures (depression, anxiety, pain, quality of life, sleep disturbance, and resilience) will be assessed at baseline, 1-month, 3-months, and 6-months. Hierarchical linear modeling (HLM) will be used to evaluate the effectiveness of the PE intervention on PTSD and secondary outcomes. Descriptive statistics will examine feasibility and will include the number of participants enrolled, the number of sessions completed, fidelity of Brief PE delivery, and average scores for difficulty and helpfulness of the intervention scales for those randomized to intervention.
Successful completion of this study will provide an evidence-based program to alleviate posttraumatic distress post spinal cord injury and prevent long-term development of PTSD.
尽管创伤后应激障碍（PTSD）在脊髓损伤（SCI）人群中的患病率估计很高，但针对该人群的研究却很少。幸运的是，延长暴露疗法（PE）是一种经过充分研究且对PTSD非常有效的治疗方法。我们最近的临床试验表明，标准的12节PE课程对SCI住院患者的PTSD治疗有效。在急诊科进行的简短PE（3节）早期干预对PTSD预防也有效，但尚未在SCI患者中进行测试。因此，我们旨在首次测试简短PE干预对SCI患者预防PTSD的效果。
经历过SCI的成年人（N = 200）将在住院康复期间随机分配到以下两组之一：（a）3节60分钟的简短PE（干预组）或（b）常规治疗（对照组）。
主要结局指标（通过PSSI - 5测量的PTSD症状）和次要结局指标（抑郁、焦虑、疼痛、生活质量、睡眠障碍和心理弹性）将在基线、1个月、3个月和6个月时进行评估。分层线性模型（HLM）将用于评估PE干预对PTSD和次要结局的有效性。描述性统计将检验可行性，包括纳入的参与者数量、完成的课程数量、简短PE实施的保真度，以及随机分配到干预组的参与者在干预量表的难度和帮助程度方面的平均得分。
本研究的成功完成将提供一个基于证据的方案，以减轻脊髓损伤后的创伤后痛苦，并预防PTSD的长期发展。
