Lear M Kati, Smith Sarah M, Pilecki Brian, Stauffer Chris S, Luoma Jason B
Portland Psychotherapy Clinic, Research, and Training Center, Portland, OR, United States.
Department of Psychiatry, Oregon Health and Science University, Portland, OR, United States.
Front Psychiatry. 2023 Jul 14;14:1083354. doi: 10.3389/fpsyt.2023.1083354. eCollection 2023.
Social anxiety disorder (SAD) is a serious and prevalent psychiatric condition that heavily impacts social functioning and quality of life. Though efficacious treatments exist for SAD, remission rates remain elevated and a significant portion of those affected do not access effective treatment, suggesting the need for additional evidence-based treatment options. This paper presents a protocol for an open-label pilot study of MDMA-assisted therapy (MDMA-AT) for social anxiety disorder. The study aims to assess preliminary treatment outcomes, feasibility and safety, and psychological and physiological processes of change in the treatment of SAD with MDMA-AT. A secondary aim includes the development of a treatment manual for MDMA-AT for SAD.
The outlined protocol is a randomized, open-label delayed treatment study. We will recruit 20 participants who meet criteria with moderate-to-severe social anxiety disorder (SAD) of the generalized subtype. Participants will be randomly assigned to an immediate treatment ( = 10) or delayed treatment condition ( = 10). Those in the immediate treatment condition will proceed immediately to active MDMA-AT consisting of three preparation sessions, two medicine sessions in which they receive oral doses of MDMA, and six integration sessions over approximately a 16-week period. The delayed treatment condition will receive the same intervention after a 16-week delay. Our primary outcome is SAD symptom reduction as measured by the Liebowitz Social Anxiety Scale administered by blinded raters at post-treatment and 6 month follow up. Secondary outcomes include changes in functional impairment, feasibility and safety measures, and novel therapeutic processes of change including shame and shame-related coping, belongingness, self-concealment, and self-compassion at post-treatment. Exploratory outcomes are also discussed.
The results of this pilot trial advance the field's understanding of the acceptability and potential effectiveness of MDMA-AT for social anxiety disorder and provide an overview of relevant therapeutic mechanisms unique to SAD. We hope findings from this protocol will inform the design of subsequent larger-scale randomized controlled trials (RCT) examining the efficacy of MDMA-AT for SAD.
https://clinicaltrials.gov/, NCT05138068.
社交焦虑障碍（SAD）是一种严重且普遍的精神疾病，对社交功能和生活质量有重大影响。尽管存在有效的SAD治疗方法，但缓解率仍然很高，且很大一部分患者无法获得有效治疗，这表明需要更多基于证据的治疗选择。本文介绍了一项关于摇头丸辅助治疗（MDMA-AT）社交焦虑障碍的开放标签试点研究方案。该研究旨在评估初步治疗结果、可行性和安全性，以及MDMA-AT治疗SAD过程中的心理和生理变化过程。次要目标包括为SAD的MDMA-AT制定治疗手册。
概述的方案是一项随机、开放标签的延迟治疗研究。我们将招募20名符合广泛性亚型中度至重度社交焦虑障碍（SAD）标准的参与者。参与者将被随机分配到立即治疗组（n = 10）或延迟治疗组（n = 10）。立即治疗组的参与者将立即开始积极的MDMA-AT治疗，包括三次准备会议、两次服药会议（期间他们口服MDMA）以及在大约16周内进行的六次整合会议。延迟治疗组将在延迟16周后接受相同的干预。我们的主要结局是通过盲法评估者在治疗后和6个月随访时使用利博维茨社交焦虑量表测量的SAD症状减轻情况。次要结局包括功能损害的变化、可行性和安全性指标，以及治疗后新的治疗变化过程，包括羞耻感和与羞耻相关的应对方式、归属感、自我隐瞒和自我同情。还讨论了探索性结局。
这项试点试验的结果推进了该领域对MDMA-AT治疗社交焦虑障碍的可接受性和潜在有效性的理解，并概述了SAD特有的相关治疗机制。我们希望该方案的研究结果将为后续更大规模的随机对照试验（RCT）设计提供信息，以检验MDMA-AT治疗SAD的疗效。
