ISRCTN06461651
已完成
未知
A pragmatic non-inferiority randomised trial of the clinical and cost-effectiveness of counselling for depression versus cognitive-behaviour therapy, for clients in primary care meeting a diagnosis of moderate or severe depression
niversity of Sheffield (UK)0 个研究点目标入组 510 人2014年9月24日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Depression
- 发起方
- niversity of Sheffield (UK)
- 入组人数
- 510
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28249592 2021 results in https://pubmed.ncbi.nlm.nih.gov/34000240/ (added 18/05/2021)
研究者
入排标准
入选标准
- •Aged 18 or over
- •1\. An initial indication by the client that depression is a major focus (ascertained by the PWP during initial assessment of presenting issues)
- •2\. Weekly PHQ\-9 scores are greater or equal to 12 at the 3rd or 4th appointment with the PWP
- •3\. Client states no strong objection to either treatment sufficient for them to be unwilling to enter the trial should they be allocated to the alternate treatment
- •4\. Client meets an ICD\-10 diagnosis of moderate or severe depression using the Clinical Interview Schedule\-Revised (CIS\-R) carried out by an independent assessor
排除标准
- •1\. Presence of prior diagnosis of personality disorder, bipolar disorder, schizophrenia as indicated in the IAPT Outcomes Toolkit within the service data or from GP referral notes to the service
- •2\. Organic origin of presentation (e.g., dementia) as indicated on referral to the service by the GP
- •3\. Long\-term physical condition as denoted in service notes
- •4\. Elevated risk of suicide: if active thoughts of suicide are indicated from the CIS\-R, we will implement a risk protocol to inform the PWP or identified practitioner
- •5\. Alcohol or substance dependency: these will be determined by Questions 1 and 2 from Section I (Alcohol) and Section II (Drug) of the Mini\-International Neuropsychiatric Interview (M.I.N.I.), which yield diagnoses of current alcohol or drug dependency
结局指标
主要结局
未指定
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