Department of Clinical Psychology, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands.
Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.
Trials. 2021 Nov 27;22(1):848. doi: 10.1186/s13063-021-05712-9.
Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study's aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated.
The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains.
This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome.
Netherlands Trial Register NL6965, registered 25/04/2018.
创伤后应激障碍（PTSD）的焦点治疗通常每周进行一次或两次。初步证据表明，治疗频率会影响治疗效果，但很少有试验研究过治疗频率的影响。本研究旨在比较两种针对儿童期创伤相关 PTSD 的治疗方法——意象重述（ImRs）和眼动脱敏与再加工（EMDR）——每周两次与每周一次治疗的治疗效果。我们假设每周两次治疗比每周一次更有效。治疗频率如何影响治疗反应，治疗类型是否会调节频率效应，以及哪种治疗类型和频率最适合谁，这些也将进行研究。
IREM-Freq 试验是一项在澳大利亚、德国和荷兰的精神保健中心进行的国际多中心随机临床试验。我们的目标是招募 220 名参与者，他们将被随机分配到以下四种条件之一：（1）每周一次 EMDR，（2）每周两次 EMDR，（3）每周一次 ImRs，或（4）每周两次 ImRs。治疗包括 12 次治疗。数据将在基线时收集，直到一年的随访。主要的测量指标是临床医生评定的 PTSD 症状严重程度。次要测量指标包括自我报告的 PTSD 症状严重程度、复杂 PTSD 症状、与创伤相关的认知和情绪、抑郁症状、分离、生活质量和功能。过程测量指标包括记忆、学习、治疗联盟、动机、勉强和回避。其他调查将集中在治疗效果和 PTSD 严重程度的预测因素、EMDR 和 ImRs 的变化机制、情绪、认知和记忆的作用、治疗选择的优化、习得性无助、患者和治疗师的观点、PTSD 症状的网络结构以及突然的治疗进展。
这项研究将扩展我们对与儿童期创伤相关的 PTSD 的焦点治疗的认识，更具体地说，将扩展我们对治疗频率的认识。更深入地了解最佳治疗频率可能会提高治疗效果，减少脱落率，从而降低医疗保健成本。此外，其他研究将拓宽我们对治疗机制和影响治疗效果的变量的理解。
荷兰试验注册 NL6965，于 2018 年 4 月 25 日注册。
