King M, Sibbald B, Ward E, Bower P, Lloyd M, Gabbay M, Byford S
Department of Psychiatry and Behavioural Sciences, Royal Free and University College Medical School of University College London, UK.
Health Technol Assess. 2000;4(19):1-83.
The aim of this study was to determine both the clinical and cost-effectiveness of usual general practitioner (GP) care compared with two types of brief psychological therapy (non-directive counselling and cognitive-behaviour therapy) in the management of depression as well as mixed anxiety and depression in the primary care setting.
The design was principally a pragmatic randomised controlled trial, but was accompanied by two additional allocation methods allowing patient preference: the option of a specific choice of treatment (preference allocation) and the option to be randomised between the psychological therapies only. Of the 464 patients allocated to the three treatments, 197 were randomised between the three treatments, 137 chose a specific treatment, and 130 were randomised between the psychological therapies only. The patients underwent follow-up assessments at 4 and 12 months.
The study was conducted in 24 general practices in Greater Manchester and London.
A total of 464 eligible patients, aged 18 years and over, were referred by 73 GPs and allocated to one of the psychological therapies or usual GP care for depressive symptoms.
The interventions consisted of brief psychological therapy (12 sessions maximum) or usual GP care. Non-directive counselling was provided by counsellors who were qualified for accreditation by the British Association for Counselling. Cognitive-behaviour therapy was provided by clinical psychologists who were qualified for accreditation by the British Association for Behavioural and Cognitive Psychotherapies. Usual GP care included discussions with patients and the prescription of medication, but GPs were asked to refrain from referring patients for psychological intervention for at least 4 months. Most therapy sessions took place on a weekly basis in the general practices. By the 12-month follow-up, GP care in some cases did include referral to mental healthcare specialists.
The clinical outcomes included depressive symptoms, general psychiatric symptoms, social function and patient satisfaction. The economic outcomes included direct and indirect costs and quality of life. Assessments were carried out at baseline during face-to-face interviews as well as at 4 and 12 months in person or by post.
At 4 months, both psychological therapies had reduced depressive symptoms to a significantly greater extent than usual GP care. Patients in the psychological therapy groups exhibited mean scores on the Beck Depression Inventory that were 4-5 points lower than the mean score of patients in the usual GP care group, a difference that was also clinically significant. These differences did not generalize to other measures of outcome. There was no significant difference in outcome between the two psychological therapies when they were compared directly using all 260 patients randomised to a psychological therapy by either randomised allocation method. At 12 months, the patients in all three groups had improved to the same extent. The lack of a significant difference between the treatment groups at this point resulted from greater improvement of the patients in the GP care group between the 4- and 12-month follow-ups. At 4 months, patients in both psychological therapy groups were more satisfied with their treatment than those in the usual GP care group. However, by 12 months, patients who had received non-directive counselling were more satisfied than those in either of the other two groups. There were few differences in the baseline characteristics of patients who were randomised or expressed a treatment preference, and no differences in outcome between these patients. Similar outcomes were found for patients who chose either psychological therapy. Again, there were no significant differences between the two groups at 4 or 12 months. Patients who chose counselling were more satisfied with treatment than those who chose c
本研究旨在确定在初级医疗环境中，常规全科医生（GP）护理与两种简短心理治疗（非指导性咨询和认知行为疗法）相比，在治疗抑郁症以及混合性焦虑和抑郁症方面的临床效果和成本效益。
该设计主要是一项实用的随机对照试验，但还伴有另外两种允许患者选择的分配方法：特定治疗选择（偏好分配）和仅在心理治疗之间随机分配的选项。在分配到三种治疗的464名患者中，197名在三种治疗之间随机分配，137名选择了特定治疗，130名仅在心理治疗之间随机分配。患者在4个月和12个月时接受随访评估。
该研究在大曼彻斯特和伦敦的24家全科诊所进行。
共有464名年龄在18岁及以上的符合条件的患者由73名全科医生转诊，并被分配到一种心理治疗或常规全科医生护理以治疗抑郁症状。
干预措施包括简短心理治疗（最多12次疗程）或常规全科医生护理。非指导性咨询由有资格获得英国咨询协会认证的咨询师提供。认知行为疗法由有资格获得英国行为和认知心理治疗协会认证的临床心理学家提供。常规全科医生护理包括与患者讨论和开药，但要求全科医生在至少4个月内避免将患者转介进行心理干预。大多数治疗疗程在全科诊所每周进行一次。到12个月随访时，某些情况下的全科医生护理确实包括转介至精神卫生保健专家。
临床结局包括抑郁症状、一般精神症状、社会功能和患者满意度。经济结局包括直接和间接成本以及生活质量。评估在基线时通过面对面访谈进行，以及在4个月和12个月时亲自或通过邮寄进行。
在4个月时，两种心理治疗在减轻抑郁症状方面均比常规全科医生护理有显著更大的效果。心理治疗组患者在贝克抑郁量表上的平均得分比常规全科医生护理组患者的平均得分低4 - 5分，这一差异在临床上也具有显著性。这些差异并未推广到其他结局指标。当直接比较通过任何一种随机分配方法随机分配到心理治疗的所有260名患者时，两种心理治疗在结局上没有显著差异。在12个月时，三组患者的改善程度相同。此时治疗组之间缺乏显著差异是由于全科医生护理组患者在4个月至12个月随访期间有更大的改善。在4个月时，两个心理治疗组的患者对治疗的满意度均高于常规全科医生护理组的患者。然而，到12个月时，接受非指导性咨询治疗的患者比其他两组中的任何一组都更满意。随机分配或表达治疗偏好的患者在基线特征上几乎没有差异，这些患者在结局上也没有差异。选择任何一种心理治疗的患者也有类似的结局。同样，在4个月或12个月时两组之间没有显著差异。选择咨询治疗的患者比选择……的患者对治疗更满意
