Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder A Randomized Clinical Trial
Efficacy of Prolonged Exposure Therapy, Sertraline Hydrochloride, and Their Combination Among Combat Veterans With Posttraumatic Stress Disorder A Randomized Clinical Trial
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DOI：
10.1001/jamapsychiatry.2018.3412
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发表时间：
2019-02-01
期刊：
影响因子：
25.8
通讯作者：
Hoge, Charles W.
中科院分区：
文献类型：
--
作者：
Rauch, Sheila A. M.;Kim, H. Myra;Hoge, Charles W.
创伤后应激障碍（PTSD）治疗的荟萃分析表明，以创伤为重点的心理治疗比单独使用抗抑郁药物产生更大的益处。目的探讨延长暴露治疗加安慰剂、延长暴露治疗加盐酸舍曲林、舍曲林加强化药物管理治疗PTSD的相对疗效。设计、环境和参与者：长时间暴露和舍曲林试验是一项随机、多地点、24周的临床试验，于2012年1月26日至2016年5月9日在安娜堡退伍军人事务医疗系统、圣地亚哥退伍军人事务医疗系统、拉尔夫·h·约翰逊退伍军人事务医疗中心和马萨诸塞州总医院基地退伍军人项目进行。参与者和临床医生对药物状况不知情，结果评估者对分配不知情。参与者在第0周（入院）、第6周、第12周、第24周和第52周（随访）完成评估。参与者（N = 223）是伊拉克和/或阿富汗战争的服役人员或退伍军人，患有与战斗相关的创伤后应激障碍和至少持续3个月的显著损害（临床医生管理的创伤后应激障碍量表评分，>= 50）。分析以意向治疗为基础。到第24周，参与者完成了多达13次90分钟的延长暴露治疗。舍曲林剂量在10周内滴定，并持续到第24周；用药管理采用手工操作。主要结果和测量主要结果是过去一个月PTSD的症状严重程度，在第24周用临床医生管理的PTSD量表评分评估。结果在223名随机受试者中，149人在24周完成研究，207人（180名男性和27名女性，平均[SD]年龄为34.5[8.3岁]）被纳入意向治疗分析。使用重复测量混合模型的改良意向治疗分析显示，PTSD症状在24周内显著减轻（舍曲林加强化药物管理，33.8分；延长暴露治疗加舍曲林，32.7分；延长暴露治疗加安慰剂，29.4分；beta值，-9.39;95% CI, -11.62至-7.16;P < .001）；然而，不同治疗组的斜率没有差异（延长暴露治疗加安慰剂组，-9.39；舍曲林加强化药物管理组，-10.37；延长暴露治疗加舍曲林组，-9.99;P = 0.81）。结论和相关性在24周时，舍曲林加强化药物管理、延长暴露治疗加安慰剂、延长暴露治疗加舍曲林在PTSD症状或症状严重程度上的变化无差异。
IMPORTANCE Meta-analyses of treatments for posttraumatic stress disorder (PTSD) suggest that trauma-focused psychotherapies produce greater benefits than antidepressant medications alone.OBJECTIVE To determine the relative efficacy of prolonged exposure therapy plus placebo, prolonged exposure therapy plus sertraline hydrochloride, and sertraline plus enhanced medication management in the treatment of PTSD.DESIGN, SETTING, AND PARTICIPANTS The Prolonged Exposure and Sertraline Trial was a randomized, multisite, 24-week clinical trial conducted at the Veterans Affairs Ann Arbor Healthcare System, Veterans Affairs San Diego Healthcare System, Ralph H. Johnson Veterans Affairs Medical Center, and Massachusetts General Hospital Home Base Veterans Program between January 26, 2012, and May 9, 2016. Participants and clinicians were blinded to pill condition, and outcome evaluators were blinded to assignment. Participants completed assessments at weeks 0 (intake), 6, 12, 24, and 52 (follow-up). Participants (N = 223) were service members or veterans of the Iraq and/or Afghanistan wars with combat-related PTSD and significant impairment (Clinician-Administered PTSD Scale score, >= 50) of at least 3 months' duration. Analyses were on an intent-to-treat basis.INTERVENTION Participants completed up to thirteen 90-minute sessions of prolonged exposure therapy by week 24. Sertraline dosage was titrated during a 10-week period and continued until week 24; medication management was manualized.MAIN OUTCOMES AND MEASURES The primary outcome was symptom severity of PTSD in the past month as assessed by the Clinician-Administered PTSD Scale score at week 24.RESULTS Of 223 randomized participants, 149 completed the study at 24 weeks, and 207 (180 men and 27 women; mean [SD] age, 34.5 [8.3 years]) were included in the intent-to-treat analysis. Modified intent-to-treat analysis using a mixed model of repeated measures showed that PTSD symptoms decreased significantly during the 24 weeks (sertraline plus enhanced medication management, 33.8 points; prolonged exposure therapy plus sertraline, 32.7 points; and prolonged exposure therapy plus placebo, 29.4 points; beta,-9.39; 95% CI, -11.62 to -7.16; P < .001); however, slopes did not differ by treatment group (prolonged exposure therapy plus placebo group, -9.39; sertraline plus enhanced medication management group, -10.37; and prolonged exposure therapy plus sertraline group, -9.99; P = .81).CONCLUSIONS AND RELEVANCE No difference in change in PTSD symptoms or symptom severity at 24 weeks was found between sertraline plus enhanced medication management, prolonged exposure therapy plus placebo, and prolonged exposure therapy plus sertraline.