Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial.

Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial.
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DOI:
10.1001/jamanetworkopen.2021.36921
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发表时间:
2022-01-04
期刊:
影响因子:
13.8
通讯作者:
Shih MC
Shih MC
中科院分区:
医学1区
文献类型:
--
作者:
Schnurr PP;Chard KM;Ruzek JI;Chow BK;Resick PA;Foa EB;Marx BP;Friedman MJ;Bovin MJ;Caudle KL;Castillo D;Curry KT;Hollifield M;Huang GD;Chee CL;Astin MC;Dickstein B;Renner K;Clancy CP;Collie C;Maieritsch K;Bailey S;Thompson K;Messina M;Franklin L;Lindley S;Kattar K;Luedtke B;Romesser J;McQuaid J;Sylvers P;Varkovitzky R;Davis L;MacVicar D;Shih MC

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创伤后应激障碍(PTSD)是一种普遍存在的严重的心理健康问题。虽然有有效的心理疗法治疗PTSD,但关于其相对有效性的信息很少。比较长期暴露(PE)与认知加工疗法(CPT)治疗退伍军人创伤后应激障碍的有效性。这项随机临床试验评估了PE与CPT在美国退伍军人事务部17个医疗中心的门诊心理健康诊所招募的退伍军人中的比较有效性,从2014年10月31日至2018年2月1日,随访至2019年2月1日。使用集中掩蔽来评估主要结局。在试验开始前预先规定了检验的假设。数据分析时间为2020年10月5日至2021年5月5日。参与者被随机分配到两种认知行为疗法中的一种,PE或CPT,根据10到14个疗程的灵活方案进行治疗。主要结果是在治疗后和3个月和6个月随访期间,临床医生管理的DSM-5(CAPS-5)PTSD量表上PTSD症状严重程度从治疗前到治疗后平均值的变化。次要结局包括其他症状、功能和生活质量。分析基于所有916名随机参与者(730名[79.7%]男性和186名[20.3%]女性;平均[范围]年龄45.2 [21-80]岁),455例受试者随机分配至PE组(基线平均CAPS-5评分,39.9 [95% CI,39.1-40.7]分)和461名随机接受CPT的受试者(基线平均CAPS-5评分,40.3 [95% CI,39.5-41.1]分)。从治疗前到治疗后,PE组(标准化均值差[SMD],0.99 [95%CI,0.89-1.08])和CPT组(SMD,0.71 [95%CI,0.61-0.80])CAPS-5上的PTSD严重程度均显著改善。PE的平均改善大于CPT(最小二乘均值,2.42 [95% CI,0.53-4.31]; P = 0.01),但差异无临床意义(SMD,0.17)。自我报告的PTSD症状的结果与CAPS-5结果相当。PE组有更高的反应几率(比值比[OR],1.32 [95% CI,1.00-1.65]; P < .001),诊断丢失与CPT组相比,治疗组的生存率(OR,1.43 [95% CI,1.12-1.74]; P < .001)和缓解率(OR,1.62 [95% CI,1.24-2.00]; P < .001)。各组在其他结果上没有差异。PE组的治疗脱落率(254名参与者[55.8%])高于CPT组(215名参与者[46.6%]; P <0.01)。PE组3名受试者和CPT组1名受试者退出治疗,每个治疗组3名受试者因严重不良事件退出。这项随机临床试验发现,尽管PE在统计学上比CPT更有效,但差异并不具有临床意义,而且两个治疗组的PTSD改善都有意义。这些发现强调了共同决策的重要性,以帮助患者了解证据并选择他们首选的治疗方法。ClinicalTrials.gov标识符:NCT 01928732
Posttraumatic stress disorder (PTSD) is a prevalent and serious mental health problem. Although there are effective psychotherapies for PTSD, there is little information about their comparative effectiveness. To compare the effectiveness of prolonged exposure (PE) vs cognitive processing therapy (CPT) for treating PTSD in veterans. This randomized clinical trial assessed the comparative effectiveness of PE vs CPT among veterans with military-related PTSD recruited from outpatient mental health clinics at 17 Department of Veterans Affairs medical centers across the US from October 31, 2014, to February 1, 2018, with follow-up through February 1, 2019. The primary outcome was assessed using centralized masking. Tested hypotheses were prespecified before trial initiation. Data were analyzed from October 5, 2020, to May 5, 2021. Participants were randomized to 1 of 2 individual cognitive-behavioral therapies, PE or CPT, delivered according to a flexible protocol of 10 to 14 sessions. The primary outcome was change in PTSD symptom severity on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from before treatment to the mean after treatment across posttreatment and 3- and 6-month follow-ups. Secondary outcomes included other symptoms, functioning, and quality of life. Analyses were based on all 916 randomized participants (730 [79.7%] men and 186 [20.3%] women; mean [range] age 45.2 [21–80] years), with 455 participants randomized to PE (mean CAPS-5 score at baseline, 39.9 [95% CI, 39.1–40.7] points) and 461 participants randomized to CPT (mean CAPS-5 score at baseline, 40.3 [95% CI, 39.5–41.1] points). PTSD severity on the CAPS-5 improved substantially in both PE (standardized mean difference [SMD], 0.99 [95% CI, 0.89–1.08]) and CPT (SMD, 0.71 [95% CI, 0.61–0.80]) groups from before to after treatment. Mean improvement was greater in PE than CPT (least square mean, 2.42 [95% CI, 0.53–4.31]; P = .01), but the difference was not clinically significant (SMD, 0.17). Results for self-reported PTSD symptoms were comparable with CAPS-5 findings. The PE group had higher odds of response (odds ratio [OR], 1.32 [95% CI, 1.00–1.65]; P < .001), loss of diagnosis (OR, 1.43 [95% CI, 1.12–1.74]; P < .001), and remission (OR, 1.62 [95% CI, 1.24–2.00]; P < .001) compared with the CPT group. Groups did not differ on other outcomes. Treatment dropout was higher in PE (254 participants [55.8%]) than in CPT (215 participants [46.6%]; P < .01). Three participants in the PE group and 1 participant in the CPT group were withdrawn from treatment, and 3 participants in each treatment dropped out owing to serious adverse events. This randomized clinical trial found that although PE was statistically more effective than CPT, the difference was not clinically significant, and improvements in PTSD were meaningful in both treatment groups. These findings highlight the importance of shared decision-making to help patients understand the evidence and select their preferred treatment. ClinicalTrials.gov Identifier: NCT01928732
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