Optimal Treatment for OCD (OTO) Version 1.0
Research type
Research Study
Full title
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.
IRAS ID
136904
Contact name
Naomi Fineberg
Contact email
Sponsor organisation
Hertfordshire Partnership University NHS Foundation Trust
Eudract number
2013-003219-22
Research summary
This is a study looking at the optimal treatment for Obsessive Compulsive Disorder (OCD). OCD is a major mental illness and seriously affects quality of life. Most patients with OCD also develop other disorders such as depression and anxiety.\n\nCurrent treatment guidelines recommend either psychological (cognitive behavioural therapy - CBT) or medication (usually sertraline) and only severe cases are treated with both. It is assumed that the combination of sertraline and CBT is more effective than either given alone, however the evidence to support this is weak. A large study to investigate whether the combination is best is needed. Large studies are costly and time-consuming therefore before the large study is conducted we will conduct a small feasibility study to identify any operational problems.\n\nIn this feasibility study adults with OCD will be recruited from mental health units, from GP referrals and from IAPT (improved access to psychological therapies)units. Patients will be seen at mental health facilities in the community.\n\nSixty patients with OCD will be randomised to one of three interventions:\n• Sertraline over 52 weeks.\n• CBTwith Exposure Response Prevention (ERP\n• Sertraline and CBT \n\nPatients will be assessed using questionnaires at 0, 2, 4, 8, 16, 32, and 52 weeks. The researcher assessing them will be blinded to reduce bias. Information will also be collected on any adverse experiences, signs/symptoms and other medications they are taking. It is anticipated that recruitment will take 18 months and patients will be followed for up to 52 weeks. \n\nThe study will assess the feasibility of the trial design, including:\n1/ Feasibility of recruiting, retaining patients, and completing of study measures by the patients.\n2/ Evaluation of how well the study design worked \n3/ The safety of the patients\n4/ the resource use and quality of life of patients\n5/ Evaluation of the outcome measures to be used in the full scale trial to follow.\n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0431
Date of REC Opinion
27 Jan 2014
REC opinion
Further Information Favourable Opinion