Mindfulness-Based Interventions for OCD

NCT04914923 | Active Not Recruiting DMC

• 1 other identifier: RN440237-452052
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Cognitive Behaviour Therapy; Mindfulness-based Intervention; Mindfulness-based cognitive therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

  OCD symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS).The YBOCS is a standardized rating scale measuring 10 items pertaining to obsessions and compulsions on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Both the self-report and clinician interview versions of the YBOCS have been shown to possess high internal consistency and validity.

  Baseline to 12 weeks

Secondary Outcomes (8)

• Change from baseline in OCD symptomatology, as measured by the OCI-R (Obsessive Compulsive Inventory - Revised).

  Baseline to 12 weeks

• Change from baseline in the experience of depression, anxiety and stress symptoms, as measured by the DASS-21 (Depression, Anxiety and Stress Scale - 21 items).

  Baseline to 12 weeks

• Change from baseline in various attitudes and beliefs related to obsessional thoughts, as measured by the OBQ-44 (Obsessional Beliefs Questionnaire - 44 items).

  Baseline to 12 weeks

• Change from baseline in aspects of mindfulness, as measured by the FFMQ (Five Facet Mindfulness Questionnaire).

  Baseline to 12 weeks

• Change from baseline in functional health and well-being, as measured by the SF-36 Health Survey (Short Form 36 item Health Survey).

  Baseline to 12 weeks

Other Outcomes (1)

• Change from baseline in OCD symptomatology, as measured by the EEG headset device "Muse".

  Baseline to 12 weeks

Study Arms (3)

Cognitive Behaviour Therapy

EXPERIMENTAL

This study arm will receive 12 weeks of cognitive behaviour therapy as an intervention.

Behavioral: Cognitive Behaviour Therapy (CBT)

Mindfulness-based Cognitive Therapy

EXPERIMENTAL

This study arm will receive 12 weeks of a mindfulness-based cognitive therapy intervention, along with open mindfulness sessions via an EEG headset.

Device: Muse; Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Waitlist

NO INTERVENTION

This study arm will not receive an intervention for 12 weeks.

Interventions

Muse DEVICE

Muse is an EEG headset device created by Interaxxon to track brain waves during mindfulness sessions.

Mindfulness-based Cognitive Therapy

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

Mindfulness-based interventions (MBIs) including MBCT, are interventions that incorporate formal and informal mindfulness practice in order to treat mental health concerns.

Mindfulness-based Cognitive Therapy

Cognitive Behaviour Therapy (CBT) BEHAVIORAL

Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard treatment for OCD. The efficacy of CBT has been well established, with numerous studies demonstrating that it leads to significant and lasting reduction in OCD symptoms for the majority of completers.

Cognitive Behaviour Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
• suspected organic pathology
• an active comorbid medical condition that may require urgent intervention during the treatment.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: collaborator
• McMaster University: collaborator
• Sunnybrook Health Sciences Centre: lead

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mindfulness

Study Officials

• Neil A Rector, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatment-seeking participants at Sunnybrook Health Sciences Centre (SHSC) and St. Joseph's Healthcare Hamilton, McMaster University (McMaster) with a primary DSM-5 diagnosis of OCD will be randomly assigned to receive a: 1) 12-week MBCT group intervention, 2) a 12-week CBT intervention or 3) a 12-week waitlist condition and will complete repeated assessments at baseline, throughout treatment, at post-treatment and three-month follow-up

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 7, 2021
• Study Start: November 9, 2021
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

CA (2)