Mindfulness-Based Interventions for Obsessive-Compulsive Disorder

(MindOC Trial)

Recruiting at1 trial location

Overseen by Neil A Rector, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: OCD medications

Disqualifiers: Severe mood disorder, Schizophrenia, Substance abuse, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called Mindfulness-Based Cognitive Therapy (MBCT) for people with Obsessive-Compulsive Disorder (OCD) who haven't fully benefited from standard treatments. MBCT helps patients become more aware of their thoughts and feelings without reacting to them, which can reduce OCD symptoms. If successful, this approach could be used widely in clinical settings to help more people with OCD. Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be effective in various mental disorders and is now being explored as a complementary treatment for OCD, particularly for those who do not fully benefit from standard treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications for OCD, you must be on a stable dose for at least 8 weeks before starting the study.

What data supports the effectiveness of the treatment Mindfulness-Based Cognitive Therapy (MBCT) for Obsessive-Compulsive Disorder (OCD)?

Mindfulness-Based Cognitive Therapy (MBCT) has been shown to be effective in preventing relapse and treating various mental disorders, and it may help OCD patients who do not fully respond to traditional cognitive behavioral therapy (CBT). A pilot study suggests that MBCT could be a useful addition to CBT for OCD, helping patients manage symptoms and develop a better attitude towards their obsessions and compulsions. ^{1 2 3 4 5}

Is mindfulness-based cognitive therapy (MBCT) safe for humans?

Mindfulness-based cognitive therapy (MBCT) has been shown to be safe and helpful for various mental disorders, and patients have found it feasible and beneficial in pilot studies for obsessive-compulsive disorder (OCD). ^{2 3 4 6 7}

How is the treatment Mindfulness-Based Cognitive Therapy (MBCT) for OCD different from other treatments?

Mindfulness-Based Cognitive Therapy (MBCT) for OCD is unique because it combines mindfulness practices with cognitive therapy to help patients develop a more accepting attitude towards their obsessions and compulsive urges, potentially improving outcomes for those who do not fully respond to traditional Cognitive Behavioural Therapy (CBT). This approach may enhance the acceptability and effectiveness of treatment by integrating mindfulness, which is not typically a component of standard OCD therapies. ^{1 4 5 8 9}

Research Team

Neil A Rector, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for adults with OCD who have significant symptoms (YBOCS score > 17) and are stable on their current medication dose for at least 8 weeks. It's not suitable for those with severe mood disorders, schizophrenia, substance abuse issues, or urgent medical conditions.

Inclusion Criteria

My OCD medication dose has been stable for at least 8 weeks.

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

Exclusion Criteria

I might have a disease caused by physical or bodily issues.

Concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence

I have a health condition that might need urgent care during the treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of mindfulness-based cognitive therapy or cognitive behaviour therapy

12 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Behaviour Therapy (CBT) (Behavioural Intervention)
• Mindfulness-Based Cognitive Therapy (MBCT) (Behavioural Intervention)

Trial Overview The study tests if Mindfulness-Based Cognitive Therapy (MBCT), possibly using a device called Muse, can help reduce OCD symptoms compared to standard Cognitive Behaviour Therapy (CBT). Participants will be randomly assigned to one of the treatments in this large-scale trial.

Participant Groups

Group I: Mindfulness-based Cognitive Therapy Experimental Treatment 2 Interventions

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

Group II: Cognitive Behaviour Therapy Experimental Treatment 1 Intervention

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

Group III: Waitlist Active Control 1 Intervention

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

Cognitive Behaviour Therapy (CBT) is already approved in Canada for the following indications:

Approved in Canada as Cognitive Behaviour Therapy (CBT) for:

• Obsessive-compulsive disorder (OCD)
• Anxiety disorders
• Depression

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Dr. Rajin Mehta

Sunnybrook Health Sciences Centre

Chief Medical Officer

MD from University of Toronto

Dr. Andrew J. Smith

Sunnybrook Health Sciences Centre

President and CEO since 2017

MD, MSc from University of Toronto; Surgical Oncology Fellowship at Memorial Sloan-Kettering Cancer Center

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Evan Stein

McMaster University

Chief Medical Officer since 2015

MD, PhD

Sam

McMaster University

Chief Executive Officer since 2023

MBA from McMaster University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

Dr. Michael Heenan

St. Joseph's Healthcare Hamilton

Chief Executive Officer since 2023

PhD in Business Administration Health Policy Management, MBA in Health Services Management, and Bachelor of Arts from McMaster University

Dr. Sarah Jarmain

St. Joseph's Healthcare Hamilton

Chief Medical Officer

MD

Findings from Research

This study will evaluate the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in reducing obsessive-compulsive symptoms in 128 patients with OCD who have not responded adequately to traditional Cognitive Behavioral Therapy (CBT).

The research aims to demonstrate that MBCT is superior to a psycho-educative coaching group in improving symptoms, with outcomes measured using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at multiple time points, including 6 and 12 months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy in obsessive-compulsive disorder: protocol of a randomized controlled trial. Külz, AK., Landmann, S., Cludius, B., et al.[2022]

In a pilot study involving 12 patients with OCD, two-thirds reported a decline in their symptoms after participating in an 8-week Mindfulness-Based Cognitive Therapy (MBCT) program, indicating its potential effectiveness as a treatment.

Participants found MBCT helpful for managing their OCD, particularly in enhancing their ability to confront unpleasant emotions and live in the present, suggesting that MBCT could be a valuable complementary approach alongside traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy in obsessive-compulsive disorder - a qualitative study on patients' experiences. Hertenstein, E., Rose, N., Voderholzer, U., et al.[2021]

Exposure with response prevention (ERP) is established as the first-line psychotherapeutic treatment for obsessive-compulsive disorder (OCD), showing significant efficacy in reducing symptoms.

Combining ERP with cognitive therapy (CT) can enhance treatment outcomes by improving distress tolerance and adherence, suggesting that a tailored approach may be beneficial for patients with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. McKay, D., Sookman, D., Neziroglu, F., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) has been adapted for patients with obsessive-compulsive disorder (OCD) who still experience symptoms after cognitive behavioral therapy (CBT), showing feasibility and patient approval in a pilot study.

The modified MBCT program includes OCD-specific elements and worksheets, suggesting it could effectively complement traditional CBT in addressing the unique therapeutic needs of OCD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness based cognitive therapy (MBCT) in patients with obsessive-compulsive disorder--an adaptation of the original program]. Külz, AK., Rose, N.[2018]

In a pilot study involving 37 participants with OCD, both mindfulness-based exposure and response prevention (MB-ERP) and traditional ERP showed improvements in OCD symptoms, but MB-ERP did not result in clinically significant improvements compared to ERP alone.

While MB-ERP did not enhance OCD symptom severity or other related outcomes, it did lead to notable improvements in mindfulness, suggesting that while it may not be more effective for OCD, it could still offer benefits in mindfulness practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: Findings from a pilot randomised controlled trial. Strauss, C., Lea, L., Hayward, M., et al.[2019]

Exposure with response prevention (ERP) is established as the first-line psychotherapeutic treatment for obsessive-compulsive disorder (OCD), showing significant efficacy in reducing symptoms.

Combining ERP with cognitive therapy (CT) can enhance treatment outcomes by improving distress tolerance and adherence, suggesting that a tailored approach may be beneficial for patients with OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. McKay, D., Sookman, D., Neziroglu, F., et al.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness-based cognitive therapy (MBCT) was found to be significantly more effective than stress management training (SMT) for treating OCD, with 80% of MBCT patients showing improvement compared to only 27% in the SMT group after 12 weeks.

Patients receiving MBCT experienced notable reductions in OCD severity and specific obsessive beliefs, indicating that this therapy can effectively address key symptoms of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based cognitive therapy vs stress management training for obsessive-compulsive disorder. Mathur, S., Sharma, MP., Balachander, S., et al.[2021]

Mindfulness can enhance traditional Cognitive Behavioral Therapy (CBT) and Exposure and Response Prevention (ER-P) for treating obsessive-compulsive disorder (OCD), potentially increasing treatment efficacy and preventing relapse.

The paper discusses how mindfulness practices can be integrated into OCD treatment, addressing concerns that they might interfere with effective exposure techniques, particularly in relation to thought-action fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of mindfulness in obsessive compulsive disorder: suggestions for its application and integration in existing treatment. Fairfax, H.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy in obsessive-compulsive disorder: protocol of a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy in obsessive-compulsive disorder - a qualitative study on patients' experiences. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Mindfulness based cognitive therapy (MBCT) in patients with obsessive-compulsive disorder--an adaptation of the original program]. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: Findings from a pilot randomised controlled trial. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive-behavioral therapy for obsessive-compulsive disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of mindfulness-based cognitive therapy vs stress management training for obsessive-compulsive disorder. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The use of mindfulness in obsessive compulsive disorder: suggestions for its application and integration in existing treatment. [2018]