BACKGROUND Despite an unparalleled global refugee crisis, there are almost no studies in primary care addressing real-world conditions and longer courses of treatment that are typical when resettled refugees present to their physician with critical psychosocial needs and complex symptoms. We studied the effects of a year of psychotherapy and case management in a primary care setting on common symptoms and functioning for Karen refugees (a newly arrived population in St Paul, Minnesota) with depression. METHODS A pragmatic parallel-group randomized control trial was conducted at two primary care clinics with large resettled Karen refugee patient populations, with simple random allocation to 1 year of either: (1) intensive psychotherapy and case management (IPCM), or (2) care-as-usual (CAU). Eligibility criteria included Major Depression diagnosis determined by structured diagnostic clinical interview, Karen refugee, ages 18-65. IPCM (n = 112) received a year of psychotherapy and case management coordinated onsite between the case manager, psychotherapist, and primary care providers; CAU (n = 102) received care-as-usual from their primary care clinic, including behavioral health referrals and/or brief onsite interventions. Blinded assessors collected outcomes of mean changes in depression and anxiety symptoms (measured by Hopkins Symptom Checklist-25), PTSD symptoms (Posttraumatic Diagnostic Scale), pain (internally developed 5-item Pain Scale), and social functioning (internally developed 37-item instrument standardized on refugees) at baseline, 3, 6 and 12 months. After propensity score matching, data were analyzed with the intention-to-treat principle using repeated measures ANOVA with partial eta-squared estimates of effect size. RESULTS Of 214 participants, 193 completed a baseline and follow up assessment (90.2%). IPCM patients showed significant improvements in depression, PTSD, anxiety, and pain symptoms and in social functioning at all time points, with magnitude of improvement increasing over time. CAU patients did not show significant improvements. The largest mean differences observed between groups were in depression (difference, 5.5, 95% CI, 3.9 to 7.1, P < .001) and basic needs/safety (difference, 5.4, 95% CI, 3.8 to 7.0, P < .001). CONCLUSIONS Adult Karen refugees with depression benefited from intensive psychotherapy and case management coordinated and delivered under usual conditions in primary care. Intervention effects strengthened at each interval, suggesting robust recovery is possible. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT03788408. Registered 20 Dec 2018. Retrospectively registered.

中文翻译：

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对在初级保健中患有严重抑郁症的卡伦难民进行强化心理治疗和病例管理：一项实用的随机对照试验。

背景技术尽管发生了无与伦比的全球难民危机，但几乎没有针对现实世界条件和更长疗程的初级保健研究，这在重新安置的难民向其医生提出严重的社会心理需要和复杂症状时是典型的。我们研究了在基层医疗机构中进行一年心理治疗和病例管理对抑郁症的克伦难民（明尼苏达州圣保罗的新来者）的常见症状和功能的影响。方法在具有大量重新安置的卡伦难民患者的两个基层医疗诊所中进行了一项实用的平行组随机对照试验，对以下人群的1年进行简单随机分配：（1）强化心理治疗和病例管理（IPCM），或者（2）照常（CAU）。入选标准包括通过结构性临床临床访谈确定的重度抑郁症诊断，卡伦难民，年龄18-65。IPCM（n = 112）接受了一年的心理治疗和病例管理，由病例经理，心理治疗师和初级保健提供者现场协调；CAU（n = 102）从其初级保健诊所接受常规照护，包括行为健康转诊和/或简短的现场干预。盲人评估者收集了抑郁和焦虑症状的平均变化（通过霍普金斯症状检查表-25测量），PTSD症状（创伤后诊断量表），疼痛（内部发展的5项疼痛量表）和社交功能（内部发展的37项）的结果在基线，3、6和12个月时对难民进行标准化的文书）。倾向得分匹配后，使用意向性治疗原理，使用重复测量方差分析对效应数据进行分析，其中效应大小采用偏方平方估计。结果在214名参与者中，有193名完成了基线和随访评估（90.2％）。IPCM患者在所有时间点的抑郁症，PTSD，焦虑症和疼痛症状以及社交功能均显着改善，改善程度随时间而增加。CAU患者没有显示出明显的改善。两组之间观察到的最大平均差异是抑郁（差异为5.5，95％CI，3.9至7.1，P <.001）和基本需求/安全性（差异为5.4，95％CI，3.8至7.0，P <.001） ）。结论成年的克伦族抑郁症难民得益于深入的心理治疗和病例管理，在常规护理的常规条件下得到了协调和交付。干预效果在每个时间间隔均得到加强，表明可以实现稳健的恢复。试验注册临床试验.gov标识符：NCT03788408。已于2018年12月20日注册。已追溯注册。