Design and rationale for a randomized controlled trial testing the efficacy of aerobic exercise for patients with obsessive-compulsive disorder

Abstract Background Over the last two decades very few advances have been made in the development of new treatments for obsessive-compulsive disorder (OCD). While patients with OCD improve with available treatments (pharmacotherapy and/or cognitive-behavioral therapy), moderate levels of OCD symptoms often persist even with adequate doses and durations of these treatments. Building on the growing body of evidence for the efficacy of exercise in the treatment of other psychiatric disorders, interventions to increase aerobic exercise in patients with OCD represent a potentially useful yet relatively unexplored strategy in OCD. Methods/design One hundred and two (102) patients with clinically significant OCD symptoms despite current engagement in recommended treatments (pharmacotherapy and/or CBT) will be randomly assigned to receive either a 12-week moderate-intensity aerobic exercise (AE) intervention or a health education control (HEC) intervention. Follow-up interviews will be conducted at the end of treatment and at 3-, 6- and 12-months post-intervention. They will assess OCD severity, nonspecific anxiety, depression, quality of life, cardiorespiratory fitness and cognition (executive function). Discussion If efficacy is established, patients with OCD who have clinically significant residual symptoms despite current pharmacotherapy or CBT would gain a valuable and practical treatment augmentation option. ClinicalTrals.gov Registration: NCT01242735.