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Walk and Talk: A Randomized Controlled Trial of Multi-Modal Motion-Assisted Memory Desensitization and Reconsolidation Therapy versus Treatment as Usual for Veterans and First Responders with Posttraumatic Stress Disorder. 走路和说话:一项多模态运动辅助记忆脱敏和再巩固疗法与创伤后应激障碍退伍军人和急救人员常规治疗的随机对照试验。
IF 17.4 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-12-01 DOI: 10.1159/000549158
Mirjam J Nijdam, Pia Goorden, Irene J M Martens, Rick de Haart, Nicola S Klein, Stijn B Peeters, Martin L Waagemans, Leona Hakkaart-van Roijen, Dorien de Groot, Eric Vermetten

Introduction: Posttraumatic stress disorder (PTSD) presents a significant challenge within the treatment of mental health issues, particularly in veterans and first responders who often experience resistance to standard treatments. This study evaluated the effectiveness of a virtual reality exposure-based treatment with motion as compared to treatment as usual (TAU), as first-line treatment for PTSD within these populations.

Methods: This multicenter, parallel, single-blind, non-inferiority randomized controlled trial was conducted in three centers across the Netherlands. We included adults diagnosed with occupational or combat-related PTSD, without prior treatment history. Participants were randomized (1:1) to receive either manualized multi-modal motion-assisted memory desensitization and reconsolidation (3MDR) therapy or manualized regular trauma-focused psychotherapy (TAU). 3MDR was applied in fewer sessions than TAU. Primary outcome was self-reported PTSD severity, based on the PTSD Checklist for DSM-5, assessed at baseline, post-treatment, 3 and 6 months post-treatment. Secondary outcomes were clinician-rated PTSD, avoidance, comorbid disorders and symptoms, and functioning. The trial was prospectively registered in the Dutch Trial Register, NL-OMON55588.

Results: Between February 15, 2018, and July 22, 2022, 134 participants with PTSD were enrolled, with 67 (50%) randomized to 3MDR and 67 (50%) to TAU of whom 106 (79%) were veterans, and 28 (21%) were first responders. Significant time effects were demonstrated in self-reported and clinician-rated PTSD severity for both groups, as well as in avoidance, comorbid disorders, and functioning. At 6 months post-treatment, 3MDR proved to be non-inferior to TAU in terms of self-reported PTSD (mean difference = -2.91 [95% CI -7.92, 2.10], p = 0.25).

Conclusion: 3MDR demonstrates to be an effective alternative first-line treatment for PTSD stemming from occupational traumatic events. Even though it leans on infrastructure with a treadmill and other hardware components, it may offer an alternative over conventional trauma-focused psychotherapies for PTSD that yields savings of a quarter of time spent within therapy.

引言:创伤后应激障碍(PTSD)在心理健康问题的治疗中提出了一个重大挑战,特别是在退伍军人和急救人员中,他们经常对标准治疗产生抵抗。这项研究评估了基于虚拟现实暴露的运动治疗与常规治疗(TAU)相比的有效性,作为这些人群中创伤后应激障碍的一线治疗。方法:这项多中心、平行、单盲、非劣效性随机对照试验在荷兰的三个中心进行。我们纳入了被诊断为职业性或与战斗有关的创伤后应激障碍的成年人,他们之前没有治疗史。参与者随机(1:1)接受手动多模态运动辅助记忆脱敏和再巩固(3MDR)治疗或手动常规创伤焦点心理治疗(TAU)。3MDR的应用次数少于TAU。主要结局是自我报告的PTSD严重程度,基于DSM-5的PTSD清单,在基线、治疗后、治疗后3个月和6个月进行评估。次要结局是临床评定的创伤后应激障碍、回避、共病障碍和症状以及功能。该试验已在荷兰试验登记册上前瞻性注册,编号为NL-OMON55588。结果:在2018年2月15日至2022年7月22日期间,招募了134名PTSD患者,其中67名(50%)随机分配到3MDR, 67名(50%)随机分配到TAU,其中106名(79%)是退伍军人,28名(21%)是第一反应者。两组在自我报告和临床评定的创伤后应激障碍严重程度,以及在逃避、共病障碍和功能方面都证明了显著的时间效应。在治疗后6个月,3MDR证明在自我报告PTSD方面不逊于TAU(平均差异= -2.91 [95% CI -7.92, 2.10], p = 0.25)。结论:3MDR是治疗职业创伤事件所致PTSD的有效替代一线治疗方法。尽管它依赖于跑步机和其他硬件组件的基础设施,但它可能为创伤后应激障碍提供一种替代传统的以创伤为重点的心理治疗方法,可以节省四分之一的治疗时间。
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引用次数: 0
An Automated Virtual Reality Cognitive-Behavioural Preventive Intervention for Adults with Agoraphobic Symptoms: A Randomized Controlled Trial of Adapted gameChange in Hong Kong. 对广场恐惧症成人的自动虚拟现实认知行为预防干预:香港一项适应游戏交换的随机对照试验。
IF 17.4 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-12-01 DOI: 10.1159/000549113
Amy T Y Chan, Amanda C M Li, Alan C Y Tong, Daniel Freeman, Yi Mien Koh, Winnie W S Mak

Introduction: Agoraphobic avoidance, fear of situations that seem hard to escape, is common across mental disorders and often remains untreated due to stigma and limited service access. Automated virtual reality (VR) exposure therapy offers a scalable alternative by enabling safe, guided simulations of feared situations. This randomized controlled trial evaluated the efficacy of a culturally adapted version of gameChange VR for reducing agoraphobic avoidance among adults in Hong Kong without psychiatric diagnoses.

Methods: 272 participants were randomly assigned to either a three-session VR intervention (n = 146) or a waitlist control condition (n = 126). Assessments were conducted at baseline, 3-week, and 1-month follow-ups. Compared to the control condition, participants in the VR intervention condition showed significant reductions in the primary outcome of agoraphobic avoidance (Cohen's d = 0.89), and all the secondary outcomes of agoraphobic distress (d = 1.0), social anxiety (d = 0.91), fear of negative evaluation (d = 0.68), generalized anxiety (d = 0.50), depressive symptoms (d = 0.67), and functional impairment (d = 0.85) at 3 weeks.

Results: Significant group differences for all outcomes remained at the 1-month follow-up. Higher baseline levels of agoraphobic symptoms were associated with larger improvements in agoraphobic avoidance.

Conclusion: These findings suggest that the automated VR intervention is effective in reducing agoraphobic symptoms in non-clinical populations and appears to be a scalable treatment in Asia where stigma is strong. Future studies could include longer follow-ups and address pandemic-related confounds on avoidance behaviours.

对广场恐惧症的回避,即对似乎难以逃脱的情况的恐惧,在精神障碍中很常见,但由于污名化和获得服务的机会有限,往往得不到治疗。自动化虚拟现实(VR)暴露疗法提供了一种可扩展的替代方案,通过安全,引导模拟恐惧情况。本随机对照试验评估了文化适应版本的gameChange VR在香港无精神病诊断的成年人中减少广场恐惧症回避的功效。方法:272名参与者被随机分配到三个阶段的VR干预组(n = 146)或候补控制组(n = 126)。在基线、3周和1个月随访时进行评估。与对照组相比,VR干预条件下的参与者在3周时广场恐惧症回避的主要结果(Cohen’s d = 0.89)和广场恐惧症痛苦(d = 1.0)、社交焦虑(d = 0.91)、负面评价恐惧(d = 0.68)、广泛性焦虑(d = 0.50)、抑郁症状(d = 0.67)和功能障碍(d = 0.85)的所有次要结果均显着降低。结果:在1个月的随访中,所有结果仍有显著的组间差异。广场恐惧症症状的基线水平越高,广场恐惧症回避的改善程度越高。结论:这些研究结果表明,自动VR干预在减少非临床人群的广场恐惧症症状方面是有效的,并且在耻辱感强烈的亚洲似乎是一种可扩展的治疗方法。未来的研究可能包括更长时间的随访,并解决与大流行有关的回避行为混淆问题。
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引用次数: 0
The World Health Organization's Early Adolescent Skills for Emotions: A systematic review on current evidence regarding effectiveness and implementation. 世界卫生组织的青少年早期情感技能:关于有效性和实施的现有证据的系统审查。
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-28 DOI: 10.1159/000549240
Lea M Schaubruch,Christian G Schäfer,Clara F Burmeister,Klaus Lieb,Sarah K Schäfer
INTRODUCTIONAdolescents in many low- and middle-income countries are frequently exposed to adversities such as armed conflicts and economic hardship. These stressors occur during a critical developmental period marked by profound physical, social, and psychological changes, increasing vulnerability to mental disorders. To address this mental health care need, the World Health Organization (WHO) and UNICEF developed Early Adolescent Skills for Emotions (EASE), a 10-session group intervention for adolescents and their caregivers. This systematic review summarizes current evidence regarding the effectiveness and implementation of EASE.METHODSWe searched five electronic databases up to July 26, 2025, for trials evaluating the effects of EASE on adolescents' mental distress and caregivers' parenting behaviors. Random-effects multilevel meta-analyses were conducted using standardized mean differences (SMDs) at post-intervention and 3-month follow-up, complemented by a qualitative synthesis of implementation outcomes. Preregistration-ID: CRD42023488490.RESULTSNo evidence was found for superiority of EASE over a 1-session psychoeducation control on overall mental distress or caregiver outcomes. However, for the primary outcome internalizing symptoms, there was strong evidence of a very small to small favorable effect at post-intervention, SMD=-0.17, 95% CI [-0.31, -0.04], which was maintained at follow-up. Implementation studies indicated that EASE is acceptable, feasible, and delivered with good fidelity; yet low caregiver engagement and contextual challenges hindered implementation.CONCLUSIONObserved effects were smaller than those reported for a comparable WHO intervention for adults, highlighting substantial scope for optimization. Additional high-quality trials are warranted to improve the effectiveness of EASE and maximize its potential public health impact.
许多低收入和中等收入国家的青少年经常面临武装冲突和经济困难等逆境。这些压力源发生在发育的关键时期,以深刻的身体、社会和心理变化为标志,增加了对精神障碍的脆弱性。为了满足这一心理保健需求,世界卫生组织(世卫组织)和儿童基金会制定了青少年早期情绪技能(EASE),这是一项针对青少年及其照顾者的10期小组干预。本系统综述总结了目前关于EASE有效性和实施的证据。方法检索截至2025年7月26日的5个电子数据库,收集评估EASE对青少年精神困扰及照顾者教养行为影响的试验。在干预后和3个月的随访中使用标准化平均差异(SMDs)进行随机效应多水平荟萃分析,并辅以实施结果的定性综合。Preregistration-ID: CRD42023488490。结果没有证据表明EASE在总体精神困扰或照顾者结局方面优于1期心理教育控制。然而,对于主要结局内化症状,有强有力的证据表明干预后的有利效果非常小到小,SMD=-0.17, 95% CI[-0.31, -0.04],并在随访中保持。实施研究表明,EASE是可接受的、可行的,并且交付的保真度很高;然而,护理人员参与度低和环境挑战阻碍了实施。结论:观察到的效果小于WHO对成人的类似干预措施,这表明还有很大的优化空间。有必要进行更多高质量的试验,以提高EASE的有效性,并最大限度地发挥其潜在的公共卫生影响。
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引用次数: 0
Trait-like and State-like Oxytocin: A Biomarker of Alliance in Patients with Depression and Borderline Personality Disorder. 特质样和状态样催产素:抑郁症和边缘型人格障碍患者联盟的生物标志物。
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-25 DOI: 10.1159/000549729
Galit Peysachov,Amit Tchizick,Jaime Delgadillo,Simone Shamay-Tsoory,Sigal Zilcha-Mano
INTRODUCTIONPatients with Major depressive disorder (MDD) and Borderline personality disorder (BPD) show a poorer prognosis compared to patients without BPD. A potential contributor is the complexity of establishing a therapeutic alliance with patients with BPD. A potential underlying biological mechanism is Oxytocin (OT), a hormone associated with social bonding and trust. The aim of this study was to assess whether the interaction between OT pre-session (session-level trait-like) and change in OT throughout session (state-like) in both patients and therapists predicts the therapeutic alliance in patients with MDD and varying severity of BPD. We hypothesized that patients with higher BPD severity would show a compensatory pattern, where increase in state-like OT would compensate for low session-level trait-like OT, resulting in a stronger alliance. We also explored this interplay in the therapists' OT.METHODEighty-four patients from a randomized control trial were assessed for BPD severity prior to beginning 16 sessions of short-term psychotherapy. Both patients and therapists provided saliva samples pre- and post- sessions 4, 8, 12 and 16 for OT analysis. Alliance was measured post-session. A series of linear mixed-effects models was used to test the hypothesis.RESULTSOur hypothesis was partially confirmed. In patients with higher BPD severity, when therapists had low session-level trait-like OT, the more they increased in state-like OT, patients rated their alliance as stronger. However, this compensatory pattern did not emerge in patients.CONCLUSIONThese findings demonstrate the potential importance of OT as a biomarker of therapeutic processes in patients with MDD and BPD.
重度抑郁症(MDD)和边缘型人格障碍(BPD)患者的预后比无BPD患者差。一个潜在的因素是与BPD患者建立治疗联盟的复杂性。一个潜在的潜在生物学机制是催产素(OT),一种与社会联系和信任相关的激素。本研究的目的是评估患者和治疗师在治疗前(治疗水平特征样)和整个治疗过程中(状态样)的OT变化之间的相互作用是否能预测重度抑郁症和不同严重程度BPD患者的治疗联盟。我们假设BPD严重程度较高的患者会表现出一种代偿模式,即状态类OT的增加会补偿低会话水平的特征类OT,从而形成更强的联盟。我们还探讨了治疗师的OT中的这种相互作用。方法:84例随机对照试验患者在16期短期心理治疗开始前进行BPD严重程度评估。患者和治疗师都提供了4、8、12和16次治疗前后的唾液样本用于OT分析。联盟是在会后测量的。使用一系列线性混合效应模型来检验这一假设。结果我们的假设得到部分证实。在BPD严重程度较高的患者中,当治疗师进行低会话水平的特征类OT时,他们进行状态类OT的次数越多,患者认为他们的联盟越强。然而,这种代偿模式并未在患者中出现。结论:这些发现证明了OT作为重度抑郁症和BPD患者治疗过程的生物标志物的潜在重要性。
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引用次数: 0
Sustainability of Treatment Success 5 Years after Exposure-Based Cognitive-Behavioral Therapy for Anxiety Disorders. 基于暴露的认知行为疗法治疗焦虑症5年后治疗成功的可持续性。
IF 17.4 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-24 DOI: 10.1159/000549073
Andre Pittig, Ingmar Heinig, Volker Arolt, Christina Bartnick, Udo Dannlowski, Jürgen Deckert, Katharina Domschke, Thomas Fydrich, Stephan Goerigk, Alfons O Hamm, Maike Hollandt, Tilo Kircher, Katja Koelkebeck, Ulrike Lueken, Jürgen Margraf, Peter Neudeck, Paul Pauli, Jan Richter, Isabelle Ridderbusch, Winfried Rief, Silvia Schneider, Benjamin Straube, Andreas Ströhle, Yunbo Yang, Hans-Ulrich Wittchen, Jürgen Hoyer

Introduction: Achieving sustainable success in the treatment of anxiety disorders remains a central objective in mental health care. Although research has demonstrated the short-term efficacy of psychotherapy, evidence regarding long-term sustainability is limited. This study examined treatment outcomes 5 years after prediction-error-based exposure therapy.

Methods: For 355 patients (616 eligible; 58% follow-up rate), newly collected follow-up data on anxiety symptoms and psychosocial functioning were compared to pretreatment, posttreatment, and 6-month follow-up data from a multicenter clinical trial characterized by high treatment fidelity.

Results: Improvements in anxiety symptoms and psychosocial functioning that were evident at posttreatment and 6-month follow-up were largely preserved after 5 years. No significant differences emerged between randomized groups of temporally intensified and non-intensified exposure. From 6 months to 5 years, overall remission rates remained stable, with the majority of patients exhibiting no reliable change in symptom severity. Reliable relapse occurred in 4.9% and reliable new remission in 6.5%. Most patients (63.4%) did not seek additional treatment. Among those who did, depression (64.2%) and anxiety (60.5%) were the most frequently cited reasons, although only a minority (6.0%) sought further treatment exclusively for anxiety. Additional treatment during the follow-up period was associated with higher symptom severity throughout assessments.

Conclusion: These findings highlight the sustainability and long-term public health benefits of exposure-based CBT for anxiety disorders. Most patients do not need additional treatments for mental disorders even 5 years after treatment. Nevertheless, further efforts are needed to optimize interventions for those patients who do not achieve remission or experience relapse.

引言:在治疗焦虑症方面取得持续成功仍然是精神卫生保健的中心目标。虽然研究证明了心理治疗的短期疗效,但关于长期可持续性的证据有限。这项研究检查了基于预测错误的暴露疗法5年后的治疗结果。方法:对355例患者(616例符合条件,58%的随访率),新收集的焦虑症状和心理社会功能的随访数据与治疗前、治疗后和6个月的随访数据进行比较,这些数据来自一项治疗保真度高的多中心临床试验。结果:在治疗后和6个月的随访中,焦虑症状和心理社会功能的改善在5年后基本保持不变。时间强化和非强化暴露随机分组之间没有显著差异。从6个月到5年,总体缓解率保持稳定,大多数患者的症状严重程度没有可靠的变化。可靠复发发生率为4.9%,可靠新缓解发生率为6.5%。大多数患者(63.4%)没有寻求额外治疗。在这些人中,抑郁(64.2%)和焦虑(60.5%)是最常被提及的原因,尽管只有少数人(6.0%)专门为焦虑寻求进一步治疗。随访期间的额外治疗与整个评估过程中较高的症状严重程度相关。结论:这些发现强调了基于暴露的CBT治疗焦虑症的可持续性和长期公共健康益处。大多数患者甚至在治疗5年后也不需要额外的精神障碍治疗。然而,需要进一步的努力来优化那些没有达到缓解或复发的患者的干预措施。
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引用次数: 0
Acknowledgement to Reviewers. 向审稿人致谢。
IF 17.4 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-20 DOI: 10.1159/000549200
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引用次数: 0
Improving patient involvement: It's now mandatory! 改善患者参与:现在是强制性的!
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-20 DOI: 10.1159/000549700
Til Wykes
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引用次数: 0
An Online Guided Written Exposure Therapy for Symptoms of Posttraumatic Stress Disorder: A Randomized Controlled Trial. 创伤后应激障碍症状的在线指导书面暴露疗法:一项随机对照试验
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-19 DOI: 10.1159/000549609
Muyang Li,Ye Zhao,David Rosenfield,Zeyu Guo,Mingcen Wei,Shijia Fan,Yu Li,Yinyin Zang
INTRODUCTIONAccess to effective post-traumatic stress disorder (PTSD) treatment is limited in low-resource regions (LRRs).METHODSWe conducted a randomized controlled trial to evaluate the efficacy of Guided Written Exposure (GWE), an online therapy developed for LRRs, in reducing PTSD, depression, and insomnia symptoms compared to minimal contact control (MCC). Adults (N=95) meeting DSM-5 criteria for PTSD or subthreshold PTSD were randomly assigned to GWE (N=65) or MCC (N=30) in China from June 27, 2022, to August 11, 2023, with a final follow-up on April 16, 2024. Assessments were conducted at pre-treatment, post-treatment, and 1-month follow-up for both groups, and at 3- and 6-month follow-ups for the GWE group. The primary outcome was the PTSD Symptom Scale Interview-DSM5 (PSSI-5, assessed by blinded evaluators) and PTSD CheckList-5 (PCL-5).RESULTSGWE had significantly lower PSSI-5 (1-month: d=-0·74, 95% CI [-0·98, -0·51], p<·001) and lower PCL-5 (1-month: d=-0·79, 95% CI [-1·03, -0·54], p<·001) than MCC. Reliable change in PTSD symptoms at 1-month: GWE 65% (42/65) vs. MCC 37% (11/30), p=·01. GWE also had significantly lower depression and insomnia severity than MCC at post-treatment and 1-month follow-up. Effects maintained through 6 months for PTSD, depression, and insomnia in the GWE group.CONCLUSIONSGWE may be an efficacious intervention for individuals with PTSD in LRRs.
在低资源地区(lrr),获得有效的创伤后应激障碍(PTSD)治疗是有限的。方法:我们进行了一项随机对照试验,以评估引导书面暴露(GWE)的疗效,与最小接触控制(MCC)相比,GWE是一种为lrr开发的在线治疗,在减少PTSD、抑郁和失眠症状方面。在2022年6月27日至2023年8月11日期间,符合DSM-5 PTSD或阈下PTSD标准的成人(N=95)在中国随机分为GWE组(N=65)或MCC组(N=30),最终随访时间为2024年4月16日。两组在治疗前、治疗后和1个月随访时进行评估,GWE组在3个月和6个月随访时进行评估。主要结果为PTSD症状量表访谈- dsm5 (psi -5,由盲法评估者评估)和PTSD检查表-5 (PCL-5)。结果gwe患者psi -5(1个月:d=- 0.74, 95% CI [- 0.98, - 0.51], p<·001)和PCL-5(1个月:d=- 0.79, 95% CI [- 0.03, - 0.54], p<·001)明显低于MCC。1个月后PTSD症状的可靠变化:GWE 65% (42/65) vs. MCC 37% (11/30), p= 0.01。在治疗后和1个月的随访中,GWE的抑郁和失眠严重程度也明显低于MCC。GWE组对PTSD、抑郁和失眠的影响持续了6个月。结论sgwe可能是一种有效的干预措施。
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引用次数: 0
Therapeutic change may begin before the therapist and patient ever meet: Pre-treatment alliance changes predict clinical outcomes. 治疗改变可能在治疗师和患者见面之前就开始了:治疗前联盟的改变可以预测临床结果。
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-18 DOI: 10.1159/000548510
Sigal Zilcha-Mano
Mechanisms of change are widely assumed to be activated by the onset of treatment. This foundational premise underlies decades of psychotherapy research and guides the timing of measurement and intervention in clinical science. The present study challenges this assumption by demonstrating that one of the most well-established predictors of treatment outcome-the therapeutic alliance-not only changes before therapy begins, but that these early, pre-treatment changes predict both alliance development and symptom reduction throughout treatment. In a randomized controlled trial for depression (N=100), the therapeutic alliance was assessed twice before patients met their therapist, and weekly thereafter. The pre-treatment change in alliance significantly predicted subsequent alliance dynamics and clinical improvement, above and beyond baseline levels. The findings remained robust even after controlling for pre-treatment outcome expectations and previous treatment experience. These findings suggest that mechanisms traditionally viewed as the result of treatment targeting may, in fact, be antecedents. By revealing pre-treatment shifts in a mechanism once thought to be non-existent prior to patient-therapist contact, this work may challenge fundamental assumptions in clinical psychology and highlights the need to reconceptualize therapeutic change as a dynamic, temporally extended process that may begin before any intervention has occurred. Such a shift has implications for how we define, measure, and intervene on core mechanisms of human change.
改变的机制被广泛认为是在治疗开始时激活的。这一基本前提奠定了数十年心理治疗研究的基础,并指导了临床科学测量和干预的时机。目前的研究挑战了这一假设,证明了治疗结果最完善的预测因素之一——治疗联盟——不仅在治疗开始前发生变化,而且这些早期的、治疗前的变化预测了整个治疗过程中联盟的发展和症状的减轻。在一项针对抑郁症的随机对照试验中(N=100),在患者见治疗师之前对治疗联盟进行两次评估,之后每周评估一次。治疗前联盟的变化显著预测了随后的联盟动态和临床改善,高于和超过基线水平。即使在控制了治疗前的预期结果和以前的治疗经验后,研究结果仍然是强有力的。这些发现表明,传统上被视为治疗靶向结果的机制实际上可能是先决条件。通过揭示在患者-治疗师接触之前曾经被认为不存在的机制中的治疗前转变,这项工作可能挑战临床心理学的基本假设,并强调需要将治疗变化重新定义为一个动态的、暂时延长的过程,这个过程可能在任何干预发生之前就开始了。这种转变对我们如何定义、衡量和干预人类变化的核心机制具有启示意义。
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引用次数: 0
Placebo effect of verbal instructions coupled with pharmacological treatment: results from a randomized controlled trial in migraine patients. 口头说明与药物治疗相结合的安慰剂效应:偏头痛患者随机对照试验的结果。
IF 22.8 1区 医学 Q1 PSYCHIATRY Pub Date : 2025-11-18 DOI: 10.1159/000548932
Sara Romanazzo,Francesca Monti,Sara Ceccatelli,Francesco De Cesaris,Alberto Chiarugi,Fiammetta Cosci
INTRODUCTIONVerbal instructions modulate the expectation concerning a given drug. Knowing that the prescribing clinician is positive and enthusiastic toward the prescribed treatment may lead to positive expectations. We tested whether administering strongly positive verbal instructions together with a pharmacological prescription might trigger a placebo effect in migraine patients.METHODSOutpatients (n = 102) were randomly assigned to: (a) an experimental condition: the pharmacological prescription was coupled to strongly positive verbal instructions; (b) a control condition: the prescription was coupled to positive verbal instructions. Subjects were assessed before the prescription (T0), 7-day (T1), 15-day (T2), 1-month (T3), 2-month (T4), and 3-month after it (T5). At each assessment point, Headache Impact Test (HIT-6) and two Numeric Rating Scales (NRSs) were proposed. Kellner's scale of change was administered at T1-T5.RESULTSPatients who received strongly positive instructions had no HIT decrease (p = 0.177; η2 = 0.034). Patients who received positive instructions had HIT decrease (p = 0.006; η2 = 0.770). No difference was found between the groups. No significant across timepoints change of expectations was observed in the group who received strongly positive instructions (p = 0.433; η2 = 0.021) or in the group who received positive instructions (p = 0.151; η2 = 0.037). Since the first group had a decrease across timepoints of the score while the second group had a peak at T2, difference between them was statistically significant (p = 0.029; η2 = 0.049).CONCLUSIONStrongly positive verbal instructions did not produce placebo effect.
口头说明调节对某一药物的期望。知道开处方的临床医生对所规定的治疗是积极和热情的,可能会导致积极的期望。我们测试了是否给予强烈积极的口头指导和药物处方可能会引发偏头痛患者的安慰剂效应。方法102例门诊患者随机分配到:(a)实验条件:药物处方与强烈积极的口头指导相结合;(b)对照条件:处方与积极的口头指示相结合。分别于开药前(T0)、开药后7天(T1)、15天(T2)、开药后1个月(T3)、2个月(T4)、3个月(T5)对受试者进行评估。在每个评估点,提出头痛冲击测试(HIT-6)和两个数值评定量表(NRSs)。在t1 ~ t5阶段采用Kellner变化量表。结果接受强阳性指导的患者HIT无明显下降(p = 0.177; η2 = 0.034)。接受阳性指导的患者HIT降低(p = 0.006; η2 = 0.770)。两组之间没有发现差异。在接受强烈积极指导的组(p = 0.433; η2 = 0.021)和接受积极指导的组(p = 0.151; η2 = 0.037)中,期望在时间点上没有显著变化。由于第一组在各时间点评分均下降,而第二组在T2达到峰值,故两组间差异有统计学意义(p = 0.029; η2 = 0.049)。结论强烈积极的口头指导不产生安慰剂效应。
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引用次数: 0
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Psychotherapy and Psychosomatics
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