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创伤后应激障碍伴精神病性障碍患者的延长暴露与眼动脱敏再处理治疗与等待治疗的随机临床试验

Prolonged exposure vs eye movement desensitization and reprocessing vs waiting list for posttraumatic stress disorder in patients with a psychotic disorder: a randomized clinical trial.

机构信息

Parnassia Psychiatric Institute, Den Haag, the Netherlands.

Mental Health Organization Oost Brabant Land van Cuijk en Noord Limburg, Boxmeer, the Netherlands.

出版信息

JAMA Psychiatry. 2015 Mar;72(3):259-67. doi: 10.1001/jamapsychiatry.2014.2637.

Abstract

IMPORTANCE

The efficacy of posttraumatic stress disorder (PTSD) treatments in psychosis has not been examined in a randomized clinical trial to our knowledge. Psychosis is an exclusion criterion in most PTSD trials.

OBJECTIVE

To examine the efficacy and safety of prolonged exposure (PE) therapy and eye movement desensitization and reprocessing (EMDR) therapy in patients with psychotic disorders and comorbid PTSD.

DESIGN, SETTING, AND PARTICIPANTS: A single-blind randomized clinical trial with 3 arms (N = 155), including PE therapy, EMDR therapy, and waiting list (WL) of 13 outpatient mental health services among patients with a lifetime psychotic disorder and current chronic PTSD. Baseline, posttreatment, and 6-month follow-up assessments were made.

INTERVENTIONS

Participants were randomized to receive 8 weekly 90-minute sessions of PE (n = 53), EMDR (n = 55), or WL (n = 47). Standard protocols were used, and treatment was not preceded by stabilizing psychotherapeutic interventions.

MAIN OUTCOMES AND MEASURES

Clinician-rated severity of PTSD symptoms, PTSD diagnosis, and full remission (on the Clinician-Administered PTSD Scale) were primary outcomes. Self-reported PTSD symptoms and posttraumatic cognitions were secondary outcomes.

RESULTS

Data were analyzed as intent to treat with linear mixed models and generalized estimating equations. Participants in the PE and EMDR conditions showed a greater reduction of PTSD symptoms than those in the WL condition. Between-group effect sizes were 0.78 (P < .001) in PE and 0.65 (P = .001) in EMDR. Participants in the PE condition (56.6%; odds ratio [OR], 3.41; P = .006) or the EMDR condition (60.0%; OR, 3.92; P < .001) were significantly more likely to achieve loss of diagnosis during treatment than those in the WL condition (27.7%). Participants in the PE condition (28.3%; OR, 5.79; P = .01), but not those in the EMDR condition (16.4%; OR, 2.87; P = .10), were more likely to gain full remission than those in the WL condition (6.4%). Treatment effects were maintained at the 6-month follow-up in PE and EMDR. Similar results were obtained regarding secondary outcomes. There were no differences in severe adverse events between conditions (2 in PE, 1 in EMDR, and 4 in WL). The PE therapy and EMDR therapy showed no difference in any of the outcomes and no difference in participant dropout (24.5% in PE and 20.0% in EMDR, P = .57).

CONCLUSIONS AND RELEVANCE

Standard PE and EMDR protocols are effective, safe, and feasible in patients with PTSD and severe psychotic disorders, including current symptoms. A priori exclusion of individuals with psychosis from evidence-based PTSD treatments may not be justifiable.

TRIAL REGISTRATION

isrctn.com Identifier: ISRCTN79584912.

摘要

重要性

据我们所知,创伤后应激障碍 (PTSD) 治疗在精神病中的疗效尚未在随机临床试验中进行过检验。精神病是大多数 PTSD 试验的排除标准。

目的

研究延长暴露 (PE) 疗法和眼动脱敏再处理 (EMDR) 疗法在伴有精神病性障碍和并发 PTSD 的患者中的疗效和安全性。

设计、设置和参与者:这是一项单盲随机临床试验,共有 3 个组(N=155),包括 13 家门诊心理健康服务机构中的 PE 治疗组、EMDR 治疗组和等待名单(WL)组,参与者为有终身精神病性障碍和当前慢性 PTSD 的患者。进行了基线、治疗后和 6 个月随访评估。

干预措施

参与者被随机分配接受 8 周每周 90 分钟的 PE(n=53)、EMDR(n=55)或 WL(n=47)治疗。使用了标准方案,并且在治疗之前没有进行稳定的心理治疗干预。

主要结局和测量指标

临床医生评定的 PTSD 症状严重程度、PTSD 诊断和完全缓解(根据临床医生管理的 PTSD 量表)是主要结局。自我报告的 PTSD 症状和创伤后认知是次要结局。

结果

采用线性混合模型和广义估计方程进行意向治疗分析。PE 和 EMDR 组的 PTSD 症状减轻程度大于 WL 组。组间效应大小分别为 0.78(P<0.001)和 0.65(P=0.001)。PE 组(56.6%;比值比 [OR],3.41;P=0.006)或 EMDR 组(60.0%;OR,3.92;P<0.001)在治疗期间获得诊断损失的可能性显著高于 WL 组(27.7%)。PE 组(28.3%;OR,5.79;P=0.01),而不是 EMDR 组(16.4%;OR,2.87;P=0.10),获得完全缓解的可能性显著高于 WL 组(6.4%)。PE 和 EMDR 的治疗效果在 6 个月随访时仍保持。次要结局也得到了类似的结果。各组之间在严重不良事件方面没有差异(PE 组 2 例,EMDR 组 1 例,WL 组 4 例)。PE 疗法和 EMDR 疗法在任何结局上均无差异,参与者退出率也无差异(PE 组 24.5%,EMDR 组 20.0%,P=0.57)。

结论和相关性

标准的 PE 和 EMDR 方案在伴有 PTSD 和严重精神病性障碍的患者中是有效、安全且可行的,包括当前症状。将患有精神病的个体排除在基于证据的 PTSD 治疗之外可能是不合理的。

试验注册

isrctn.com 标识符:ISRCTN79584912。

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