ISRCTN07706836已完成4 期
A randomised controlled feasibility trial comparing clinical and cost effectiveness of cognitive behavioural therapy (CBT) and selective serotonin reuptake inhibitors (SSRI) and their combination in the management of obsessive compulsive disorder.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
研究概览
简要总结
2018 results in https://doi.org/10.1016/j.euroneuro.2017.10.027 (added 27/08/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Community based service-users, aged 18-65 years.
- •2. DSM-IV OCD, determined by a psychiatrist using the MINI for DSM-IV
- •3. Duration of symptoms >1 year (from medical history)
- •4. Baseline score >16 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
排除标准
- •1. History of psychotic disorder (schizophrenia, psychotic symptoms, bipolar disorder), Tourette syndrome(tic disorders not amounting to Tourette syndrome will not be exclusionary), organic mental disorder, psychosurgery, personality disorder of borderline or histrionic type.
- •2. Alcohol/substance-abuse disorders within the past 12 months.
- •3. Any other DSM-IV Axis I disorder that is considered the primary focus of treatment
- •4) Severe depression, defined by a Montgomery-Asberg Depression Rating Scale (MADRS) >30 at baseline.
- •5. Actively planning suicide (scoring >4 on item 10 of MADRS)or judged by the clinician to be at significant risk of self-harm.
- •6. Attended CBT involving ERP from an accredited (British Association of Behavioural and Cognitive Psychotherapies (BABCP) approved or equivalent) therapist (eg. IAPTs stage 2) in the last 6 months.
- •7. Failed (inadequate clinical response, equivalent to <25% improvement) >=2 previous adequate (>12weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist.
- •8. Failed (inadequate clinical response,equivalent to <25% improvement) >=2 previous adequate (>12weeks) trials of any SSRI or clomipramine taken at optimal doses (if maximum SPC dose, evidence of intolerance of the higher dose is needed) with adequate adherence.
- •9. Needing regular psychotropic drugs other than study medication during the study (except hypnotics which will be allowed provided the dose has been stable for >12 weeks and remains so throughout the study period).
- •10. Currently involved in a treatment research study.
- •11. Acute or unstable physical illness including Hepatitis, HIV/AIDS, Creutzfeldt-Jakob disease
- •12. Needing regular specified medication known to interact adversely with sertraline.
- •13. Individual reasons making it difficult to comply with the treatment-programme, including the washout-period.
- •14. Inadequate understanding of English to participate in treatment or give informed consent.
- •15. Women of child-bearing age not using reliable contraception.
- •16. Pregnant or breast-feeding women. Women of child bearing potential will be asked to perform a urine pregnancy test at screening.
- •17. History of liver disease.
- •18. Epilepsy.
- •19. History of cardiovascular disease or blood disorders that increase bleeding tendency. Eg. Platelet disorder.
研究者
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