Haugen Tina, Halvorsen Joar Øveraas, Friborg Oddgeir, Mork Paul Jarle, Mikkelsen Gustav, Schei Berit, Hagemann Cecilie
Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
Department of Mental Healthcare, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
Pilot Feasibility Stud. 2024 Sep 2;10(1):118. doi: 10.1186/s40814-024-01541-0.
Rape is one of the trauma incidents with the highest risk of subsequent post-traumatic stress disorder. Early interventions, such as prolonged exposure therapy (PE), have shown promise in preventing PTSD following a sexual assault. The primary objective of this internal pilot trial was to examine the feasibility of the EIR study protocol, which used modified prolonged exposure therapy (mPE) as a preventive intervention after rape.
This parallel two-arm clinical pilot study involved three sexual assault centers (SACs) in Trondheim, Oslo, and Vestfold, with data collected between June 2022 and March 2023. Women seeking assistance at one of these three SACs within 72 h after rape or attempted rape received acute medical treatment and forensic examinations. Women who wanted further psychosocial treatment were, if eligible and consenting, recruited to complete baseline assessments and a clinical interview before being randomized to one of two study arms. The intervention group prescribed up to five sessions of modified PE (mPE) in addition to treatment as usual (TAU), starting within the first 14 days after the rape incident, followed by weekly sessions. The other group received TAU. The present pilot evaluation is based on 22 participants, i.e., nine mPE + TAU and 13 TAU alone. Primary outcomes were predefined progression criteria regarding recruitment, retention, intervention implementation, a harm reporting system, and applying biological measurements and actigraphy.
During the 6-month recruitment period, 235 women visited the three SACs. After eligibility screening and consent, 22 (9.4%) women were randomized. Three months later, 14 (63.6%) participants completed the final assessments. Intervention implementation was successful using trained SAC personnel to deliver mPE. The harm reporting system was used according to the study's plan, and adverse and serious adverse events were detected during the trial. The biological measurements and actigraphy had substantial missing data but were still considered usable for statistical analyses.
It may be feasible to conduct a full-scale RCT of early intervention after rape by comparing mPE + TAU to TAU alone. Minor design refinements were made to the protocol to enhance the main study outcome.
ClinicalTrials.gov Identifier: NCT05489133. Registered on 15 July 2022, retrospectively.
强奸是后续创伤后应激障碍风险最高的创伤事件之一。早期干预措施，如延长暴露疗法（PE），已显示出在预防性侵犯后创伤后应激障碍方面的前景。这项内部试点试验的主要目的是检验EIR研究方案的可行性，该方案使用改良延长暴露疗法（mPE）作为强奸后的预防性干预措施。
这项平行双臂临床试点研究涉及特隆赫姆、奥斯陆和西福尔的三个性侵犯中心（SAC），数据收集于2022年6月至2023年3月之间。在强奸或强奸未遂后72小时内在这三个SAC之一寻求帮助的女性接受了急性医疗治疗和法医检查。如果符合条件并同意，想要进一步接受心理社会治疗的女性会被招募来完成基线评估和临床访谈，然后被随机分配到两个研究组之一。干预组除了常规治疗（TAU）外，还规定进行多达五节改良延长暴露疗法（mPE）课程，从强奸事件后的前14天内开始，随后每周进行一次。另一组接受常规治疗（TAU）。本次试点评估基于22名参与者，即9名mPE+TAU组和13名单独TAU组。主要结果是关于招募、留存、干预实施、伤害报告系统以及应用生物测量和活动记录的预定义进展标准。
在为期6个月的招募期内，235名女性访问了这三个性侵犯中心。经过资格筛选和同意后，22名（9.4%）女性被随机分组。三个月后，14名（63.6%）参与者完成了最终评估。通过使用经过培训的性侵犯中心人员来实施mPE，干预实施取得成功。伤害报告系统按照研究计划使用，并且在试验期间检测到了不良事件和严重不良事件。生物测量和活动记录有大量缺失数据，但仍被认为可用于统计分析。
通过比较mPE+TAU与单独TAU来对强奸后的早期干预进行全面随机对照试验可能是可行的。对方案进行了一些小的设计改进以提高主要研究结果。
ClinicalTrials.gov标识符：NCT05489133。于2022年回顾性注册。
