Efficacy and fMRI-based response predictors to mindfulness-based cognitive therapy in obsessive-compulsive disorder: Study protocol for a randomised clinical trial.

About 40-50% of patients with obsessive-compulsive disorder (OCD) continue to experience obsessions and compulsions after first-line treatments. Mindfulness-based cognitive therapy (MBCT) is proposed as an augmentation strategy to help patients decentre from distressful thoughts, potentially increasing non-reactivity and reducing compulsions. This randomized clinical trial of 60 OCD patients who did not respond to first-line treatments will compare an MBCT program (10 weekly 120-minute sessions) with treatment as usual. The primary outcome is change in OCD severity, measured by clinician and self-reported assessments. Comprehensive evaluations will include comorbid clinical variables, neuropsychological functioning, thought content, and structural and functional neuroimaging at baseline and post-intervention. This is the first RCT in this population to examine clinical, neuropsychological, and neuroimaging variables together to identify neural patterns associated with MBCT response.

Study at a glance

Abstract

Around 40-50% of patients with obsessive-compulsive disorder (OCD) suffer from obsessions and compulsions after receiving first-line treatments. Mindfulness-based cognitive therapy (MBCT) has been proposed as a reasonable augmentation strategy for OCD. MBCT trains to decentre from distressful thoughts and emotions by focusing on them voluntarily and with consciousness. This practice develops alternative ways to deal with obsessions, which could increase non-reactivity behaviours and, in turn, reduce compulsions. This study aims to investigate the efficacy of MBCT to improve OCD symptoms. Secondly, it pursues to investigate which socio-demographic, clinical, and neurobiological characteristics mediate or moderate the MBCT response; and identify potential biomarkers of positive/negative response. This study is a randomised clinical trial (RCT) of 60 OCD patients who do not respond to first-line treatments. Participants will be randomised to either an MBCT program or treatment as usual. The MBCT group will undergo 10 weekly sessions of 120min. Principal outcome: change in OCD severity symptoms using clinician and self-reported measures. Also, participants will undergo a comprehensive evaluation assessing comorbid clinical variables, neuropsychological functioning and thought content. Finally, a comprehensive neuroimaging protocol using structural and functional magnetic resonance imaging will be acquired in a 3T scanner. All data will be obtained at baseline and post-intervention. This study will assess the efficacy of mindfulness in OCD patients who do not achieve clinical recovery after usual treatment. It is the first RCT in this subject examining clinical, neuropsychological and neuroimaging variables to examine the neural patterns associated with the MBCT response. NCT03128749.