Mindfulness-Based Interventions for OCD: Efficacy, Mechanisms, and Biological Predictors of Outcome

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Obsessive-compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting about 2% of the population. It is characterized by the presence of recurrent obsessions and/or compulsions that are time consuming and cause marked distress and/or impairment. Untreated, OCD runs a chronic and deteriorating course. According to the World Health Organization, OCD is among the top 10 leading causes of disability worldwide. Examination of non-medicinal treatments for OCD has focused on two distinct treatments: exposure and response prevention (ERP) and cognitive therapy (CT), often combined into an integrated cognitive-behavioural treatment (CBT). CBT is considered the first line psychological treatment for OCD, with estimates of response rates of between 70-80%. However, there are a significant number of treatment non-responders and the majority of responders are still left with impairing residual symptoms. One area of investigation that has shown potential benefit for general mood and anxiety disorders has been mindfulness-based interventions (MBIs), yet the potential benefits of MBIs in OCD has been largely unexamined, except for several small preliminary studies that show clinical promise. The purpose of this study is to examine the clinical benefits of a standardized MBI treatment for OCD in a large-scale, multi-site randomized controlled trial. The results of this study will directly determine whether Mindfulness can be considered an effective treatment for OCD. If this study can demonstrate that a short-term mindfulness intervention can significantly reduce the suffering associated with OCD, then the findings could easily be translated into routine clinical care in and out of hospital settings. Results of this study will also potentially add to our understanding of the mechanisms that drive OCD symptoms, improve our knowledge of psychological treatment mechanisms, and elucidate how biological factors influence psychological treatment outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• experiencing clinically significant obsessive-compulsive symptoms based on the Yale-Brown Obsessive Compulsive Scale (YBOCS; score \> 17)

• if on medications for OCD, must be stabilized, i.e. are currently receiving an adequate dose (equivalent of 40mg/day of fluoxetine) for an adequate duration (at least 8 weeks of treatment) prior to the initiation of the study.

Locations
Other Locations
Canada
St. Joseph's Healthcare Hamilton
RECRUITING
Hamilton
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Neil A Rector, PhD
neil.rector@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2021-11-09
Estimated Completion Date: 2025-09
Participants
Target number of participants: 420
Treatments
Experimental: Cognitive Behaviour Therapy
This study arm will receive 12 weeks of cognitive behaviour therapy as an intervention.
Experimental: Mindfulness-based Cognitive Therapy
This study arm will receive 12 weeks of a mindfulness-based cognitive therapy intervention, along with open mindfulness sessions via an EEG headset.
No_intervention: Waitlist
This study arm will not receive an intervention for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre
Collaborators: McMaster University, St. Joseph's Healthcare Hamilton

This content was sourced from clinicaltrials.gov