Efficacy and fMRI-based response predictors to mindfulness-based cognitive therapy in obsessive-compulsive disorder: Study protocol for a randomised clinical trial.
Neus Miquel-giner, Muriel Vicent-gil, Ignacio Martínez-zalacaín, Daniel Porta-casteras, Lorea Mar, Marina López-solà, Jessica R Andrews-hanna, Carles Soriano-mas, José Manuel Menchón, Narcís Cardoner, Pino Alonso, Maria Serra-blasco, Clara López-solà
Revista de psiquiatria y salud mental January 1, 2023 DOI: 10.1016/j.rpsm.2022.11.002
Summary
Nearly half of patients with obsessive-compulsive disorder (OCD) continue to experience symptoms after first-line treatments. Mindfulness-based cognitive therapy (MBCT) offers a promising alternative, training individuals to manage distressing thoughts more effectively. In a randomized clinical trial involving 60 OCD patients unresponsive to standard treatments, participants will engage in 10 weekly MBCT sessions. The study aims to evaluate changes in OCD severity and explore socio-demographic, clinical, and neurobiological characteristics influencing treatment response, utilizing comprehensive neuroimaging techniques for deeper insights into brain activity.
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.