Topic: Mental Health
Conditions
Interventions
CBT with ERP, 16hrs over 8 weeks
Sertraline, dose 50-200mg aiming for 200mg
Sertraline + CBT with ERP, Sertraline 50-200mg with CBT with ERP 16 hours over 8 weeks
Study Entry : Single Randomisation only
Sponsors
Hertfordshire Partnership University NHS Foundation Trust
University of Hertfordshire (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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 =2 previous adequate (>12weeks) trials of CBT involving ERP from an accredited (BABCP-approved or equivalent) therapist. 8. Failed (inadequate clinical response,equivalent to =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in Y-BOCS within and between treatment arms; Timepoint(s): Screening, baseline, weeks 2,4,8,16,24,32 and 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed