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Clinical effectiveness and cost

泰然健康网
2025-05-08 03:03

Introduction Evidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their clinical effectiveness and cost-effectiveness are unclear. Methods and analysis This is a multicentre, randomised, parallel-group, researcher-masked, superiority trial. Study participants will be aged 18 and over, have probable personality disorder and be treated by mental health staff in seven centres in England. We will exclude people who are: unwilling or unable to provide written informed consent, have a coexisting organic or psychotic mental disorder, or are already receiving psychological treatment for personality disorder or on a waiting list for such treatment. In the intervention group, participants will be offered up to 10 individual sessions of Structured Psychological Support. In the control group, participants will be offered treatment as usual plus a single session of personalised crisis planning. The primary outcome is social functioning measured over 12 months using total score on the Work and Social Adjustment Scale (WSAS). Secondary outcomes include mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction, and resource use and costs. The primary analysis will compare WSAS scores across the 12-month period using a general linear mixed model adjusting for baseline scores, allocation group and study centre on an intention-to-treat basis. In a parallel process evaluation, we will analyse qualitative data from interviews with study participants, clinical staff and researchers to examine mechanisms of impact and contextual factors. Ethics and dissemination The study complies with the Helsinki Declaration II and is approved by the London—Bromley Research Ethics Committee (IRAS ID 315951). Study findings will be published in an open access peer-reviewed journal; and disseminated at national and international conferences. Trial registration number [ISRCTN13918289][1]. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN13918289

中文翻译：

英格兰心理健康服务中对可能的人格障碍患者的结构化心理支持的临床有效性和成本效益：一项随机对照试验的研究方案

简介人格障碍患者的循证心理治疗通常包括参加为期数月的小组会议。已经开发了持续时间少于 6 个月的低强度心理干预，但其临床效果和成本效益尚不清楚。方法和分析这是一项多中心、随机、平行组、研究人员设盲的优效性试验。研究参与者将年满 18 岁，可能患有人格障碍，并在英格兰的七个中心接受心理健康工作人员的治疗。我们将排除以下人员：不愿意或不能提供书面知情同意书，患有共存的器质性或精神病性精神障碍，或已经在接受人格障碍心理治疗或正在等待此类治疗。在干预组中，参与者将获得最多 10 次单独的结构化心理支持。在对照组中，参与者将照常接受治疗，并接受一次个性化的危机规划。主要结果是使用工作和社会适应量表（WSAS）的总分测量 12 个月的社会功能。次要结局包括心理健康、自杀行为、与健康相关的生活质量、患者评价的总体改善和满意度以及资源使用和成本。主要分析将使用一般线性混合模型比较 12 个月期间的 WSAS 评分，该模型在意向治疗的基础上调整基线评分、分配组和研究中心。在平行过程评估中，我们将分析与研究参与者、临床工作人员和研究人员访谈的定性数据，以检查影响机制和背景因素。伦理和传播该研究符合赫尔辛基宣言 II，并得到伦敦-布罗姆利研究伦理委员会（IRAS ID 315951）的批准。研究结果将发表在开放获取的同行评审期刊上;并在国内和国际会议上传播。试验注册号 [ISRCTN13918289][1]。[1]：/external-ref？link_type=ISRCTN&access_num=ISRCTN13918289