Abstract
BackgroundUK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help (GSH) to more intensive psychological and pharmacological interventions. Cognitive behavioural therapy (CBT), including exposure and response prevention, is the recommended psychological treatment. However, whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective, a more robust evidence base of their clinical and cost effectiveness and acceptability is required.Methods/DesignOur proposed study will test two different self-help treatments for OCD: 1) computerised CBT (cCBT) using OCFighter, an internet-delivered OCD treatment package; and 2) GSH using a book. Both treatments will be accompanied by email or telephone support from a mental health professional. We will evaluate the effectiveness, cost and patient and health professional acceptability of the treatments.DiscussionThis study will provide more robust evidence of efficacy, cost effectiveness and acceptability of self-help treatments for OCD. If cCBT and/or GSH prove effective, it will provide additional, more accessible treatment options for people with OCD.Trial registrationCurrent Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011
Highlights
UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach
Our study aims to determine: 1) the clinical and cost effectiveness of two self-managed Cognitive behavioural therapy (CBT) interventions compared to a CBT waiting list in the management of adults with OCD in the short term at 3- and 6-month follow-up; 2) the clinical and cost effectiveness of self-managed therapies plus conventional CBT compared to waiting list plus conventional CBT at 12-month follow-up; and 3) patient compliance and patient and health professional acceptability of the two self-managed therapy packages
An internal pilot was conducted to explore the validity of recruitment. This phase of the Obsessive Compulsive Treatment Efficacy Trial (OCTET) was conducted over the first nine months of the recruitment phase and was designed to assess three questions relating to the main trial: 1) is it feasible to recruit the numbers required for a fully powered trial in the designated recruitment time available? 2) Do participants remain on a CBT waiting list for a sufficient length of time to conduct an evaluation of the short-term clinical and cost effectiveness of self-managed therapies? and 3) Is it feasible to retain the proposed 6-month outcome as the primary assessment for short term clinical effectiveness?
Summary
The proposed trial is being conducted to explore if the interventions (GSH and cCBT), designed to provide more rapid and efficient access to patients with OCD, are effective. On the assumption that governance agreement should be available within 30 days of submission it was estimated that delays across sites would approximate to 10% loss of capacity (or the equivalent of one site in the initial stages of recruitment) In response to these issues, which may impact upon trial completion, decisions have been made to recruit additional sites and identify new recruitment strategies such as invitation letters being sent to all patients currently waiting for a CBT appointment, not restricted to those who have an indication of OCD in their NHS records. KL is chief investigator, led the design of the trial, developed the GSH intervention manual, trained health professionals and assisted with the drafting of the manuscript.
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