Mindfulness Meditation Utilizing an EEG Biofeedback Device for the Treatment for Obsessive Compulsive Disorder

April 8, 2019 updated by: Sunnybrook Health Sciences Centre

Evaluating the Use of Mindfulness Meditation Utilizing a Consumer-Grade EEG Biofeedback Device for Patients Awaiting Treatment for Obsessive Compulsive Disorder

The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most efficacious treatment intervention for OCD, there is a growing literature indicating the mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety symptoms as well as reducing relapse risk following treatment.The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this study is to examine the potential benefits of using a consumer grade EEG-based biofeedback device that allows clients to engage in home based mindfulness meditation practices while they are waiting to receive clinical services. Specifically, this study will investigate the effects of meditation home practice on symptom alleviation, as related to specific OCD related cognitive processes.The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups.Outcome measures will involve ratings of OCD symptom severity, OCD beliefs, mindfulness, and use of thought control strategies. At baseline, mid treatment (session 4), and post intervention, participants will complete the Yale-Brown Obsessive Compulsive Scale, Obsessive Compulsive Inventory, Obsessive Beliefs Questionnaire, Five Factor Mindfulness Questionnaire, Thought Control Questionnaire, Acceptance and Action Questionnaire, Mind Wandering Scale and the Metacognitions Questionnaire. Once per week, participants will complete the YBOCS, TCQ, and MW. This weekly data will be collected online using the "Survey Monkey" web portal. Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All inclusion and exclusion criteria are consistent with the established guidelines for our service - there are no additional study specific criteria. Potential subjects are referred to the service with a query of OCD. Due to the nature of the assessment procedures, which include English-language self-report questionnaires and scales, the ability to communicate in written and spoken English is an inclusion criterion. disorder

Exclusion Criteria:

  • Exclusion criteria include a) those with active substance abuse/dependence, b) suspected organic pathology, c) recent suicide attempt/active suicidality, d) active bipolar, psychotic disorder or post-traumatic stress

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Mindfulness
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
Device: Mindfulness
Clients will use a consumer grade EEG device that provides guided mindfulness home practices
NO_INTERVENTION: Control
The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Completed once per week, for eight weeks
A self-report inventory of obsessive compulsive symptoms
Completed once per week, for eight weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Obsessive Compulsive Inventory
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of obsessive compulsive symptoms
Completed at three timepoints - week 1, week 4, week 8
Obsessive Beliefs Questionnaire
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of OCD beliefs
Completed at three timepoints - week 1, week 4, week 8
Five Factor Mindfulness Questionnaire
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of mindfulness
Completed at three timepoints - week 1, week 4, week 8
Thought Control Questionnaire
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of use of thought control strategies
Completed at three timepoints - week 1, week 4, week 8
Acceptance and Action Questionnaire
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of experiential avoidance
Completed at three timepoints - week 1, week 4, week 8
Mind Wandering Scale
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of mind wandering
Completed at three timepoints - week 1, week 4, week 8
Metacognitions Questionnaire
Time Frame: Completed at three timepoints - week 1, week 4, week 8
Self-report measure of metacognitive strategies
Completed at three timepoints - week 1, week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Peggy Richter, M.D., Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 196-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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