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Obsessive-Compulsive DisorderMindOCNCT04914923

Mindfulness-Based Interventions for OCD

A study testing Muse, Cognitive Behaviour Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
Muse, Cognitive Behaviour Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
2 sitesCanada
Study dates
9 Nov 2021to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

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

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.

Read the detailed description

Cognitive Behavioural Therapy (CBT) is a first line psychological treatment for OCD with estimated response rates of between 70-80%. However, there are still a substantial number of treatment non-responders and the vast majority of responders are left with impairing residual symptoms. One new area of investigation that has shown potential benefit for the treatment of OCD has been mindfulness-based interventions (MBIs). This emerging literature provides proof of principle for the delivery and potential efficacy of MBIs for OCD, particularly as an adjunct to CBT, with all studies reporting large (d > .80) treatment effects. To date, only our teams' small, non-controlled pilot study (N=19) has shown promise for a MBI as a stand-alone treatment for OCD separate from CBT (d = 1.10). However, all results to date for MBI treatments for OCD must be interpreted with caution as they have utilized small, underpowered sample sizes, have not included control groups, and failed to control for potentially confounding variables (e.g., medications, self-initiated exposures). The proposed four-year, two-site randomized controlled trial at two of Canada's leading OCD treatment centres (Sunnybrook Health Sciences Centre and St. Joseph's Healthcare Hamilton) that have been involved in developing and piloting MBI treatments for OCD will aim to test whether a structured, Mindfulness-Based Cognitive Therapy (MBCT) intervention for OCD is an efficacious treatment for a large, heterogeneous sample of DSM-5 (Diagnostic Statistical Manual of Mental Disorders 5th edition) diagnosed OCD participants. The primary aim of this proposed study is to examine whether a developed and piloted MBCT treatment for OCD is efficacious when compared to a waitlist condition and to explore its efficacy compared to CBT treatment for OCD. A secondary aim of the study is to examine the putative treatment mechanisms of MBCT. Past research examining treatment mechanisms in CBT for OCD have focused on the reduction of obsessional beliefs, anxiety sensitivity, and safety behaviours in producing better outcomes. In contrast, the hypothesized mechanisms in MBI treatments include the development of mindfulness skills such as acting with awareness, non-reactivity to and non-judging of inner experience, and reduction in mind wandering. The large-scale, powered RCT (randomized control trial) design will permit the examination of whether MBCT and CBT include overlapping or distinct treatment mechanisms. Treatment outcomes will be assessed with standardized measures of OCD symptomatology, general measures of mood and anxiety, a reliable and valid EEG measure to assess cognitive changes across treatment. 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 Canadian 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 genetic/biological factors influence psychological treatment outcomes.

Being tested
Muse, Cognitive Behaviour Therapy (CBT), Mindfulness-Based Cognitive Therapy (MBCT)
Keywords
Cognitive Behaviour Therapy, Mindfulness-based Intervention, Mindfulness-based cognitive therapy
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MuseDevice

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

  • Cognitive Behaviour Therapy (CBT)Behavioural

    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.

  • Mindfulness-Based Cognitive Therapy (MBCT)Behavioural

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

Study groups in NCT04914923
Study groupRoleWhat they receive
Cognitive Behaviour TherapyExperimentalThis study arm will receive 12 weeks of cognitive behaviour therapy as an intervention.
Receives: Behavioral: Cognitive Behaviour Therapy (CBT)
Mindfulness-based Cognitive TherapyExperimentalThis study arm will receive 12 weeks of a mindfulness-based cognitive therapy intervention, along with open mindfulness sessions via an EEG headset.
Receives: Device: Muse; Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
WaitlistNo interventionThis study arm will not receive an intervention for 12 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 12 weeks

Secondary outcomes (8)
  1. Change from baseline in OCD symptomatology, as measured by the OCI-R (Obsessive Compulsive Inventory - Revised).

    This self -report short version of the OCI consisting of 18 items measures six distinct factors: Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing, to chart the change in OCD symptomatology across time.

    Measured: Baseline to 12 weeks

  2. 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).

    Depression, anxiety and stress severity will be measured using the Depression Anxiety Stress Scales-21,a self-report questionnaire comprising three subscales with seven items each for depression, anxiety and stress. The DASS-21 shows high internal consistency, high reliability in distinguishing between depression, anxiety and stress in adults, and good convergent and discriminant validity.

    Measured: Baseline to 12 weeks

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

    The Obsessional Beliefs Questionnaire is a 44-item self-report questionnaire designed to assess the extent to which respondents agree or disagree with various attitudes and beliefs related to obsessional thoughts. The OBQ is internally consistent, and evidences good test-retest reliability, convergent validity, and discriminant validity.

    Measured: Baseline to 12 weeks

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

    The Five Facet Mindfulness Questionnaire is a self-report questionnaire containing 39 items that assess five aspects of mindfulness: observing, describing, acting with awareness, non-judgment of inner experiences, and non-reactivity to inner experience.

    Measured: Baseline to 12 weeks

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

    The SF-36 Health Survey is a brief questionnaire containing 36 items about functional health and well-being. The reliability and validity of the SF-36 have been well documented. It has demonstrated good treatment sensitivity

    Measured: Baseline to 12 weeks

  6. Change from baseline in the degree which individuals find distress intolerable, as measured by the DTS (Distress Tolerance Scale).

    The Distress Tolerance Scale is a 15-item self-report questionnaire that measures the degree to which individuals find distress intolerable, unacceptable, impairing, and necessary to avoid. Distress tolerance has been linked to OCD.

    Measured: Baseline to 12 weeks

  7. Change from baseline in the fear of consequences of anxiety, as measured by the ASI-3 (Anxiety Sensitivity Index).

    The Anxiety Sensitivity Index-3 is an 18-item self-report measure of the degree to which individuals fear the consequences of anxiety. It is composed of three subscales: fear of the physical, social, and cognitive consequences of anxiety.

    Measured: Baseline to 12 weeks

  8. Change from baseline in the time spent ruminating, as measured by the RRS (Ruminative Response Scale).

    The Ruminative Response Scale is a frequently used 22-item measure of the amount to which participants are engaging in rumination, or repetitive, passive, and negative self-focus.

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start9 Nov 2021
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914923
Sponsor's protocol ID
RN440237-452052
Acronym
MindOC
Status last verified
Feb 2026
First submitted
31 May 2021
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Muse, Cognitive Behaviour Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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