Clinical effectiveness and cost
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
中文翻譯:
英格蘭心理健康服務中對可能的人格障礙患者的結(jié)構(gòu)化心理支持的臨床有效性和成本效益:一項隨機對照試驗的研究方案
簡介 人格障礙患者的循證心理治療通常包括參加為期數(shù)月的小組會議。已經(jīng)開發(fā)了持續(xù)時間少于 6 個月的低強度心理干預,但其臨床效果和成本效益尚不清楚。方法和分析 這是一項多中心、隨機、平行組、研究人員設盲的優(yōu)效性試驗。研究參與者將年滿 18 歲,可能患有人格障礙,并在英格蘭的七個中心接受心理健康工作人員的治療。我們將排除以下人員:不愿意或不能提供書面知情同意書,患有共存的器質(zhì)性或精神病性精神障礙,或已經(jīng)在接受人格障礙心理治療或正在等待此類治療。在干預組中,參與者將獲得最多 10 次單獨的結(jié)構(gòu)化心理支持。在對照組中,參與者將照常接受治療,并接受一次個性化的危機規(guī)劃。主要結(jié)果是使用工作和社會適應量表 (WSAS) 的總分測量 12 個月的社會功能。次要結(jié)局包括心理健康、自殺行為、與健康相關(guān)的生活質(zhì)量、患者評價的總體改善和滿意度以及資源使用和成本。主要分析將使用一般線性混合模型比較 12 個月期間的 WSAS 評分,該模型在意向治療的基礎上調(diào)整基線評分、分配組和研究中心。在平行過程評估中,我們將分析與研究參與者、臨床工作人員和研究人員訪談的定性數(shù)據(jù),以檢查影響機制和背景因素。 倫理和傳播 該研究符合赫爾辛基宣言 II,并得到倫敦-布羅姆利研究倫理委員會 (IRAS ID 315951) 的批準。研究結(jié)果將發(fā)表在開放獲取的同行評審期刊上;并在國內(nèi)和國際會議上傳播。試驗注冊號 [ISRCTN13918289][1]。[1]:/external-ref?link_type=ISRCTN&access_num=ISRCTN13918289
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