What side effects are associated with this type of intervention?

Common treatments for OCD, such as Cognitive Behavioral Therapy (CBT) and mindfulness-based cognitive therapy (MBCT), generally have minimal side effects, primarily involving temporary increases in anxiety or distress as patients confront their obsessions during exposure exercises. Pharmacological treatments, often used alongside these therapies, include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). These medications can cause side effects such as nausea, headache, insomnia, sexual dysfunction, and increased anxiety, particularly at the start of treatment. Combining these therapies can enhance treatment efficacy while managing side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, and sertraline, as well as the tricyclic antidepressant clomipramine. These medications work by increasing serotonin levels in the brain, which can help reduce the symptoms of OCD. Unlike these pharmacological treatments, Mindfulness-Based Interventions (MBIs) enhance awareness and acceptance of thoughts and feelings, potentially reducing the impact of obsessions and compulsions through non-pharmacological means. While MBIs show promise in preliminary studies, they are not yet FDA-approved for OCD treatment.

What other types of research exist?

Promising novel alternatives to Mindfulness-Based Interventions (MBIs) for OCD treatment include: 1) Deep Brain Stimulation (DBS), which has shown sustained improvement in quality of life and reduction in depressive symptoms in treatment-refractory OCD patients. 2) Cognitive Behavioral Therapy (CBT), particularly Exposure and Response Prevention (ERP), which remains a first-line treatment with high response rates. 3) Pharmacotherapy options like lisdexamfetamine and phentermine-topiramate, which have demonstrated efficacy in reducing OCD symptoms in clinical trials. These alternatives offer different mechanisms of action, providing a range of options for personalized treatment plans.

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Mindfulness-Based Interventions for Obsessive-Compulsive Disorder (MindOC Trial)

N/A

Recruiting

Led By Neil A Rector, PhD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

An active comorbid medical condition that may require urgent intervention during the treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While MBCT and CBT generally have minimal side effects compared to medication, some may experience temporary increases in anxiety or distress when confronting obsessive thoughts without engaging in compulsions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

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

+5 more

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness-based Cognitive TherapyExperimental Treatment2 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 TherapyExperimental Treatment1 Intervention

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

Group III: WaitlistActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Muse

2021

N/A

~150

Cognitive Behaviour Therapy (CBT)

2003

Completed Phase 3

~200

Mindfulness-Based Cognitive Therapy (MBCT)

2014

N/A

~180

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacological approaches like SSRIs and SNRIs, which increase serotonin levels in the brain to reduce symptom severity, and psychotherapeutic methods such as Cognitive-Behavioral Therapy (CBT) with Exposure and Response Prevention (ERP), which helps patients confront and manage their obsessions and compulsions. Mindfulness-Based Interventions (MBIs) work by enhancing awareness and acceptance of thoughts and feelings, potentially reducing the impact of obsessions and compulsions. These treatments are crucial for OCD patients as they can significantly alleviate symptoms, improve daily functioning, and enhance overall quality of life.

Real-time fMRI biofeedback targeting the orbitofrontal cortex for contamination anxiety.Is mindfulness-based therapy an effective intervention for obsessive-intrusive thoughts: a case series.