Bolton Paul, Lee Catherine, Haroz Emily E, Murray Laura, Dorsey Shannon, Robinson Courtland, Ugueto Ana M, Bass Judith
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
PLoS Med. 2014 Nov 11;11(11):e1001757. doi: 10.1371/journal.pmed.1001757. eCollection 2014 Nov.
Existing studies of mental health interventions in low-resource settings have employed highly structured interventions delivered by non-professionals that typically do not vary by client. Given high comorbidity among mental health problems and implementation challenges with scaling up multiple structured evidence-based treatments (EBTs), a transdiagnostic treatment could provide an additional option for approaching community-based treatment of mental health problems. Our objective was to test such an approach specifically designed for flexible treatments of varying and comorbid disorders among trauma survivors in a low-resource setting.
We conducted a single-blinded, wait-list randomized controlled trial of a newly developed transdiagnostic psychotherapy, Common Elements Treatment Approach (CETA), for low-resource settings, compared with wait-list control (WLC). CETA was delivered by lay workers to Burmese survivors of imprisonment, torture, and related traumas, with flexibility based on client presentation. Eligible participants reported trauma exposure and met severity criteria for depression and/or posttraumatic stress (PTS). Participants were randomly assigned to CETA (n = 182) or WLC (n = 165). Outcomes were assessed by interviewers blinded to participant allocation using locally adapted standard measures of depression and PTS (primary outcomes) and functional impairment, anxiety symptoms, aggression, and alcohol use (secondary outcomes). Primary analysis was intent-to-treat (n = 347), including 73 participants lost to follow-up. CETA participants experienced significantly greater reductions of baseline symptoms across all outcomes with the exception of alcohol use (alcohol use analysis was confined to problem drinkers). The difference in mean change from pre-intervention to post-intervention between intervention and control groups was -0.49 (95% CI: -0.59, -0.40) for depression, -0.43 (95% CI: -0.51, -0.35) for PTS, -0.42 (95% CI: -0.58, -0.27) for functional impairment, -0.48 (95% CI: -0.61, -0.34) for anxiety, -0.24 (95% CI: -0.34, -0.15) for aggression, and -0.03 (95% CI: -0.44, 0.50) for alcohol use. This corresponds to a 77% reduction in mean baseline depression score among CETA participants compared to a 40% reduction among controls, with respective values for the other outcomes of 76% and 41% for anxiety, 75% and 37% for PTS, 67% and 22% for functional impairment, and 71% and 32% for aggression. Effect sizes (Cohen's d) were large for depression (d = 1.16) and PTS (d = 1.19); moderate for impaired function (d = 0.63), anxiety (d = 0.79), and aggression (d = 0.58); and none for alcohol use. There were no adverse events. Limitations of the study include the lack of long-term follow-up, non-blinding of service providers and participants, and no placebo or active comparison intervention.
CETA provided by lay counselors was highly effective across disorders among trauma survivors compared to WLCs. These results support the further development and testing of transdiagnostic approaches as possible treatment options alongside existing EBTs.
ClinicalTrials.gov NCT01459068 Please see later in the article for the Editors' Summary.
现有针对资源匮乏地区心理健康干预措施的研究采用的是由非专业人员实施的高度结构化干预，且通常不会因服务对象的不同而有所变化。鉴于心理健康问题的高共病性以及扩大多种结构化循证治疗方法（EBTs）规模时面临的实施挑战，一种跨诊断治疗方法可为基于社区的心理健康问题治疗提供额外选择。我们的目标是测试一种专门为在资源匮乏地区灵活治疗创伤幸存者中各种不同及共病障碍而设计的方法。
我们进行了一项单盲、等待名单随机对照试验，将一种新开发的适用于资源匮乏地区的跨诊断心理治疗方法——通用要素治疗法（CETA），与等待名单对照组（WLC）进行比较。CETA由外行人工作人员向缅甸的监禁、酷刑及相关创伤幸存者提供，根据服务对象的具体情况灵活调整。符合条件的参与者报告有创伤经历，且符合抑郁和/或创伤后应激障碍（PTSD）的严重程度标准。参与者被随机分配到CETA组（n = 182）或WLC组（n = 165）。由对参与者分组情况不知情的访谈者使用当地调整后的抑郁和PTSD标准测量方法（主要结局）以及功能损害、焦虑症状、攻击行为和酒精使用情况（次要结局）进行评估。主要分析采用意向性分析（n = 347），包括73名失访参与者。除酒精使用外（酒精使用分析仅限于有饮酒问题者），CETA组参与者在所有结局方面的基线症状均有显著更大程度的减轻。干预组与对照组从干预前到干预后的平均变化差异在抑郁方面为-0.49（95%置信区间：-0.59，-0.40），在PTSD方面为-0.43（95%置信区间：-0.51，-0.35），在功能损害方面为-0.42（95%置信区间：-0.58，-0.27），在焦虑方面为-0.48（95%置信区间：-0.61，-0.34），在攻击行为方面为-0.24（95%置信区间：-0.34，-0.15），在酒精使用方面为-0.03（95%置信区间：-0.44，0.50）。这相当于CETA组参与者的平均基线抑郁评分降低了77%，而对照组降低了40%，其他结局的相应数值在焦虑方面分别为76%和41%，在PTSD方面为75%和37%，在功能损害方面为67%和22%，在攻击行为方面为71%和32%。抑郁（d = 1.16）和PTSD（d = 1.19）的效应量（科恩d值）较大；功能损害（d = 0.63）、焦虑（d = 0.79）和攻击行为（d = 0.58）的效应量为中等；酒精使用方面无效应量。未出现不良事件。该研究的局限性包括缺乏长期随访、服务提供者和参与者未设盲，且未设置安慰剂或活性对照干预。
与等待名单对照组相比，外行人顾问提供的CETA在创伤幸存者的各种障碍治疗中均非常有效。这些结果支持进一步开发和测试跨诊断方法，作为现有循证治疗方法之外可能的治疗选择。
ClinicalTrials.gov NCT01459068 有关编辑总结，请见本文后文。
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