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.

Hertfordshire Partnership University NHS Foundation Trust0 sites49 target enrollmentAugust 8, 2014

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Hertfordshire Partnership University NHS Foundation Trust
Enrollment: 49
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2018 results in https://doi.org/10.1016/j.euroneuro.2017.10.027 (added 27/08/2020)

Registry

who.int

Start Date

August 8, 2014

End Date

July 7, 2017

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Hertfordshire Partnership University NHS Foundation Trust

Eligibility 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

•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.