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 人开始时间: 2014年9月24日最近更新: 2021年6月7日

适应症

试验速览

•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

•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

发起方

niversity of Sheffield (UK)