Sleep disturbances (SDs) are among the most distressing and commonly reported symptoms in posttraumatic stress disorder (PTSD). Despite increased attention on sleep in clinical PTSD research, SDs remain difficult to treat. In Phase 2 trials, 3,4-methylenedioxymethamphetamine (MDMA)–assisted psychotherapy has been shown to greatly improve PTSD symptoms. We hypothesized that MDMA-assisted psychotherapy would improve self-reported sleep quality (SQ) in individuals with PTSD and be associated with declining PTSD symptoms. Participants in four studies (n = 63) were randomized to receive 2–3 sessions of active MDMA (75–125 mg; n = 47) or placebo/control MDMA (0–40 mg, n = 16) during all-day psychotherapy sessions. The PSQI was used to assess change in SQ from baseline to the primary endpoint, 1–2 months after the blinded sessions. Additionally, PSQI scores were measured at treatment exit (TE) and 12-month follow-up. Symptoms of PTSD were measured using the CAPS-IV. At the primary endpoint, CAPS-IV total severity scores dropped more after active MDMA than after placebo/control (−34.0 vs. −12.4), p = .003. Participants in the active dose group showed more improvement in SQ compared to those in the control group (PSQI total score ΔM = −3.5 vs. 0.6), p = .003. Compared to baseline, SQ had improved at TE, p < .001, with further significant gains reported at 12-month follow-up (TE to 12-months ΔM = −1.0), p = .030. Data from these randomized controlled double-blind studies provide evidence for the beneficial effects of MDMA-assisted psychotherapy in treating SDs in individuals with PTSD.

中文翻译：

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MDMA 辅助心理治疗治疗创伤后应激障碍后睡眠质量的改善


睡眠障碍（SD）是创伤后应激障碍（PTSD）中最令人痛苦和最常见的症状之一。尽管临床创伤后应激障碍 (PTSD) 研究越来越关注睡眠，但创伤后应激障碍 (SD) 仍然难以治疗。在 2 期试验中，3,4-亚甲二氧基甲基苯丙胺 (MDMA) 辅助心理治疗已被证明可以极大改善 PTSD 症状。我们假设 MDMA 辅助心理治疗会改善 PTSD 患者自我报告的睡眠质量 (SQ)，并与 PTSD 症状的减轻相关。四项研究的参与者 ( n = 63) 在全天心理治疗期间随机接受 2-3 次活性 MDMA（75-125 毫克； n = 47）或安慰剂/对照 MDMA（0-40 毫克， n = 16）会议。 PSQI 用于评估盲法治疗后 1-2 个月的 SQ 从基线到主要终点的变化。此外，在治疗退出 (TE) 和 12 个月随访时测量 PSQI 评分。使用 CAPS-IV 测量 PTSD 的症状。在主要终点，CAPS-IV 总严重程度评分在主动 MDMA 治疗后比安慰剂/对照治疗后下降更多（-34.0 与 -12.4）， p = .003。与对照组相比，活性剂量组的参与者在 SQ 方面表现出更大的改善（PSQI 总分 Δ M = -3.5 与 0.6）， p = 0.003。与基线相比，SQ 在 TE 时有所改善， p < .001，并在 12 个月的随访中报告进一步显着改善（TE 至 12 个月 Δ M = -1.0）， p = .030。这些随机对照双盲研究的数据提供了证据，证明 MDMA 辅助心理治疗对治疗 PTSD 患者的 SD 具有有益效果。