Mindfulness-Based Interventions for Obsessive-Compulsive Disorder

(MindOC Trial)

Recruiting at 1 trial location

Overseen By Neil A Rector, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must be taking: OCD medications

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of mindfulness-based therapy for people with obsessive-compulsive disorder (OCD), a condition characterized by unwanted thoughts and repetitive behaviors that cause significant stress. It will compare the effects of mindfulness-based therapy, cognitive behavior therapy (CBT), and a waitlist control group. The goal is to determine if mindfulness can effectively reduce OCD symptoms. Individuals experiencing distressing OCD symptoms and maintaining a stable medication routine might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how mindfulness can benefit those with OCD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Mindfulness-Based Cognitive Therapy (MBCT) is safe and well-tolerated. Participants generally adhered to the therapy well, with few reports of negative effects. Research suggests that MBCT can be a promising treatment for people with obsessive-compulsive disorder (OCD), especially for those who have not fully benefited from traditional cognitive-behavioral therapy.

Cognitive Behavioral Therapy (CBT) has a strong safety record and is well-known for treating OCD in people of all ages. The therapy consistently reduces OCD symptoms and is generally considered safe for most people.

Overall, both MBCT and CBT are safe options for treating OCD, with studies supporting their use and few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Mindfulness-Based Cognitive Therapy (MBCT) for Obsessive-Compulsive Disorder (OCD) because it offers a fresh approach compared to traditional treatments like medications and standard Cognitive Behavior Therapy (CBT). MBCT combines mindfulness practices with cognitive therapy techniques, potentially enhancing self-awareness and emotional regulation. Additionally, the use of an EEG headset for open mindfulness sessions introduces a tech-driven element that could provide real-time feedback and make therapy more engaging. This unique combination might offer a more holistic treatment experience, potentially improving outcomes for those with OCD.

What evidence suggests that this trial's treatments could be effective for OCD?

Research has shown that Cognitive Behaviour Therapy (CBT), one of the treatments in this trial, effectively treats OCD. In one study, 67% of participants were considered "recovered" after treatment, and 76% maintained recovery at follow-up. Mindfulness-Based Cognitive Therapy (MBCT), another treatment option in this trial, also shows promise. Early results suggest it can significantly reduce OCD symptoms, with benefits comparable to some medications like SSRIs. However, further research is needed to confirm these long-term effects. Both methods offer potential relief for individuals with OCD. ^{6 7 8 9 10}

Who Is on the Research Team?

Neil A Rector, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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 European Union, United States, Canada for the following indications:

Approved in European Union as Cognitive Behaviour Therapy (CBT) for:

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

Approved in United States as Cognitive Behaviour Therapy (CBT) for:

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

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+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15913543/

cognitive behavior therapy vs. exposure and response ... A higher percentage of CBT participants obtained recovered status at post-treatment (67%) and at follow-up (76%), compared to ERP participants (59% and 58%, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X21000018

Cognitive behavioural therapy with exposure and response ... In summary, data from individual randomised controlled trials and existing meta-analyses suggest that CBT with ERP is an effective treatment modality for OCD.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584580/

The Efficacy of Cognitive Behavioral Therapy: A Review ... The response rates of CBT varied between 38% for treating obsessive compulsive disorder (Eddy et al., 2004) and 82% for treating body dysmorphic disorder ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.973838/full

The effectiveness of exposure and response prevention ... Conclusion: Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with medication, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0005796705000069

Cognitive behavior therapy vs. exposure and response ... A higher percentage of CBT participants obtained recovered status at post-treatment (67%) and at follow-up (76%), compared to ERP participants (59% and 58%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170287/

Cognitive-Behavioral Therapy for Obsessive-Compulsive ... CBT (ie, E/RP) has established a very strong evidence base in the treatment of children, adolescents, and adults with OCD, delivered both in-person and via ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364921000646

A systematic review and meta-analysis on the effectiveness ... Our review suggests that ERP was superior to the other groups, including both neutral and active treatments, in reducing OCD symptomatology.

8. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.130207

Cognitive-Behavioral Therapy for Obsessive-Compulsive ... This study found that both forms of ERP reduced OCD symptoms; however, the therapist-administered sessions resulted in greater improvement (26).

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6343408/

Exposure and response prevention for obsessive-compulsive ... Although OCD was once thought to be untreatable, the last few decades have seen great success in reducing symptoms with exposure and response prevention (ERP), ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834260

Exposure Therapy in Mixed Reality for Obsessive ... In this single-center randomized clinical trial including 36 patients, MERP did not significantly reduce OCD symptom severity compared with an active control ...