Saxon David, Ashley Kate, Bishop-Edwards Lindsey, Connell Janice, Harrison Phillippa, Ohlsen Sally, Hardy Gillian E, Kellett Stephen, Mukuria Clara, Mank Toni, Bower Peter, Bradburn Mike, Brazier John, Elliott Robert, Gabriel Lynne, King Michael, Pilling Stephen, Shaw Sue, Waller Glenn, Barkham Michael
Health Services Research, Centre for Psychological Services Research, School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 2DA, UK.
Sheffield IAPT (Sheffield Health & Social Care NHS Foundation Trust), St George's Community Health Centre, Winter Street, Sheffield, S3 7ND, UK.
Trials. 2017 Mar 1;18(1):93. doi: 10.1186/s13063-017-1834-6.
NICE guidelines state cognitive behavioural therapy (CBT) is a front-line psychological treatment for people presenting with depression in primary care. Counselling for Depression (CfD), a form of Person-Centred Experiential therapy, is also offered within Improving Access to Psychological Therapies (IAPT) services for moderate depression but its effectiveness for severe depression has not been investigated. A full-scale randomised controlled trial to determine the efficacy and cost-effectiveness of CfD is required.
PRaCTICED is a two-arm, parallel group, non-inferiority randomised controlled trial comparing CfD against CBT. It is embedded within the local IAPT service using a stepped care service delivery model where CBT and CfD are routinely offered at step 3. Trial inclusion criteria comprise patients aged 18 years or over, wishing to work on their depression, judged to require a step 3 intervention, and meeting an ICD-10 diagnosis of moderate or severe depression. Patients are randomised using a centralised, web-based system to CfD or CBT with each treatment being delivered up to a maximum 20 sessions. Both interventions are manualised with treatment fidelity tested via supervision and random sampling of sessions using adherence/competency scales. The primary outcome measure is the Patient Health Questionnaire-9 collected at baseline, 6 and 12 months. Secondary outcome measures tap depression, generic psychological distress, anxiety, functioning and quality of life. Cost-effectiveness is determined by a patient service receipt questionnaire. Exit interviews are conducted with patients by research assessors blind to treatment allocation. The trial requires 500 patients (250 per arm) to test the non-inferiority hypothesis of -2 PHQ-9 points at the one-sided, 2.5% significance level with 90% power, assuming no underlying difference and a standard deviation of 6.9. The primary analysis will be undertaken on all patients randomised (intent to treat) alongside per-protocol and complier-average causal effect analyses as recommended by the extension to the CONSORT statement for non-inferiority trials.
This large-scale trial utilises routinely collected outcome data as well as specific trial data to provide evidence of the comparative efficacy and cost-effectiveness of Counselling for Depression compared with Cognitive Behaviour Therapy as delivered within the UK government's Improving Access to Psychological Therapies initiative.
Controlled Trials ISRCTN Registry, ISRCTN06461651 . Registered on 14 September 2014.
英国国家卫生与临床优化研究所（NICE）指南指出，认知行为疗法（CBT）是初级保健中抑郁症患者的一线心理治疗方法。在改善心理治疗可及性（IAPT）服务中，也为中度抑郁症患者提供了一种以患者为中心的体验疗法——抑郁症咨询（CfD），但其对重度抑郁症的有效性尚未得到研究。因此，需要开展一项全面的随机对照试验来确定CfD的疗效和成本效益。
PRaCTICED是一项双臂、平行组、非劣效性随机对照试验，比较CfD与CBT。该试验采用阶梯式护理服务提供模式，嵌入当地的IAPT服务中，在第3步常规提供CBT和CfD。试验纳入标准包括年龄在18岁及以上、希望治疗抑郁症、被判定需要第3步干预且符合ICD - 10中度或重度抑郁症诊断的患者。患者通过基于网络的集中系统随机分配接受CfD或CBT，每种治疗最多进行20次。两种干预均采用手册化方式，并通过监督以及使用依从性/能力量表对治疗过程进行随机抽样来测试治疗保真度。主要结局指标是在基线、6个月和12个月时收集的患者健康问卷 - 9。次要结局指标包括抑郁症、一般心理困扰、焦虑、功能和生活质量。成本效益通过患者服务收据问卷来确定。由对治疗分配不知情的研究评估人员对患者进行退出访谈。该试验需要500名患者（每组250名），以在单侧2.5%显著性水平、90%检验效能下检验非劣效性假设——-2个患者健康问卷 - 9得分，假设无潜在差异且标准差为6.9。主要分析将对所有随机分组的患者（意向性分析）进行，同时按照非劣效性试验CONSORT声明扩展版的建议进行符合方案分析和依从者平均因果效应分析。
这项大规模试验利用常规收集的结局数据以及特定的试验数据，为抑郁症咨询与认知行为疗法在英国政府改善心理治疗可及性倡议中的比较疗效和成本效益提供证据。
受控试验ISRCTN注册库，ISRCTN06461651。于2014年9月14日注册。
