Title: Does mindfulness improve outcomes and reduce attrition for exposure and response prevention for obsessive compulsive disorder? An internal pilot study for a randomised controlled trial
Funder: Department of Health (England)

Abstract: Background Obsessive compulsive disorder (OCD) is a distressing and debilitating condition affecting approximately 1-2% of the UK population (APA, 1994; NICE, 2005). People with OCD experience repetitive unwanted and intrusive thoughts (e.g. thoughts of harm coming to a loved one) and engage in compulsive behaviours that are targeted at the intrusive thought (e.g. repeated checking). Exposure and response prevention (ERP) is a form of behaviour therapy that encourages people to gradually face their OCD triggers ('exposure') whilst not engaging in compulsive behaviours ('response prevention'). ERP has been around since the 1960s (Meyer, 1966), yet it is still the form of psychological therapy with the most robust evidence for effectiveness. It appears that cognitive therapy is no more effective than ERP (Whittal et al, 2005) and that adding cognitive therapy to ERP does not improve outcomes (Vogel et al, 2004). Consequently NICE (2005) recommend individual or group ERP (with or without cognitive therapy) as the psychological therapy for OCD. However, there are limitations with ERP. Only about 60% of people who are referred for ERP show improvement after therapy (Stanley & Turner, 1995). This is partly because some people who complete ERP do not show improvement, but it is mostly because 25-30% of people do not find the therapy acceptable and refuse or drop-out of therapy (Foa et al, 1992; Aderka et al, 2011). Mindfulness-based group therapies (MBTs) teach people to notice and accept unpleasant thoughts, feelings and urges and to choose how to respond to these in helpful ways. MBT would be expected to be of benefit for OCD as it would enable participants to notice unpleasant thoughts, feelings and urges and to choose to disengage from compulsive behaviours. RCTs have shown MBTs to be effective in reducing symptoms of depression (Barnhofer et al, 2009; Strauss et al, 2012) and to halve the risk of relapse in those with a history of recurrent depression (Ma & Teasdale, 2004; Teasdale et al, 2000). MBTs also appear effective at improving outcomes for psychosis (Chadwick et al, 2005, 2009; Dannahy et al, 2011) and anxiety disorders, including generalised anxiety disorder (Craigie et al, 2008; Evans et al, 2008) and social anxiety disorder (Koszycki et al, 2007). In addition, drop-out rates from MBTs tend to be low (Ma & Teasdale, 2004). In summary: we might expect mindfulness-enhanced ERP to improve the effectiveness of ERP and to reduce rates of attrition. However, there is a surprising dearth of published studies evaluating MBT for OCD, as we identified in a recent literature review (Hale et al, 2012). There is now a need for a robust research design. Given the lack of published studies a full trial would not be a judicious use of public money and this pilot RCT is clearly warranted. Aims The full trial research question is: does mindfulness improve outcomes and reduce attrition for exposure and response prevention for OCD? The aim of this internal pilot is to produce the effect size and 95% confidence interval between mindfulness-enhanced ERP (ME-ERP) and standard ERP. This will be used for a power calculation for the full trial. A second aim is to gather information on rates of recruitment and a third aim is to calculate attrition from the pilot study. This information will inform the development of the full trial. The full trial will replicate the pilot study and therefore data from the pilot study will be incorporated in the full trial. The full trial has the potential to improve outcomes of ERP for OCD and thereby to improve the quality of people's lives who are living with OCD and for their friends and families.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH