Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy (MBCT)
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Mindfulness-Based Cognitive Therapy, Mindfulness
Eligibility Criteria
Inclusion Criteria:
- Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
- Primary Diagnosis of OCD
- Ability to communicate in written and spoken English
Exclusion Criteria:
- Those with active substance abuse/dependence within 3 months
- Suspected organic pathology
- Recent suicide attempt/active suicidality
- Current self-injurious behaviour
- Active bipolar or psychotic disorder
- Previous completion of an MBCT course (≥ 8 weeks)
- Previous completion of an OCD-specific course of CBT (≥ 8 weeks)
- Previous completion of a general course of CBT (≥ 8 weeks) in the past 3 years
Sites / Locations
- The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness-Based Cognitive Therapy (MBCT)
Waitlist
Arm Description
MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group.
Wait list as per usual.
Outcomes
Primary Outcome Measures
Change in Symptom Severity from Baseline in OCD Measures
OCD measures will include: a self-report version of the Yale-Brown Obsessive Compulsive Scale (YBOCS-SR), the Obsessive Compulsive Inventory -Revised (OCI-R), consisting of six subscales (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralising), and the Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation)
Secondary Outcome Measures
Change in Level of Impairment from Baseline
The Sheehan Disability Scale will be used to measure level of functional impairment in three inter-related domains (work/school, social and family life).
Change in Mood from Baseline
The Beck Depression Inventory -II (BDI-II), will be used to assess depression severity.
Change in Mindfulness from Baseline
Mindfulness measures include: The Five Facet Mindfulness Questionnaire (FFMQ), used to measure the five constructs central to mindfulness (Observing, Describing, Acting with Awareness, Non-judgment of Inner Experience, and Non-reactivity to Inner Experience), and the the Self-Compassion Scale-Short Form (SCS-SF) measuring 6 components of self-compassion (Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness & Over-Identification).
Retention of Gains at Follow-up
All self-report measures will be re-administered at 6-week follow-up to measure robustness of gains post-treatment.
Full Information
NCT ID
NCT02217995
First Posted
August 13, 2014
Last Updated
September 4, 2018
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02217995
Brief Title
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
Official Title
A Pilot Randomized Trial Testing Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI treatment, partial symptom reduction is substantial. Investigations into the effectiveness of alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as paying attention in a particular way (on purpose, in the present moment and nonjudgmentally), promotes awareness and attention to internal experience and has been shown to reduce symptoms of anxiety and depression. A number of controlled studies have found Mindfulness-Based Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice, in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are allocated to the wait list, they will be randomly assigned to receive either 10 weeks of group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to the MBCT treatment group, compared to those in the wait list control group, will see greater reductions in self-reported measures of OCD symptom severity and improvement in other measures of mindfulness, mood and level of functioning. The results of this pilot study, if successful, will provide evidence towards another route by which patients can improve their OCD while waiting for clinic services or consultation. Results will also lend more evidence as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will inform further investigations into the potential addition of mindfulness techniques to standard care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Mindfulness-Based Cognitive Therapy, Mindfulness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Cognitive Therapy (MBCT)
Arm Type
Experimental
Arm Description
MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
Wait list as per usual.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy (MBCT)
Intervention Description
MBCT teaches patients to become more aware of, and to relate differently to, their thoughts, feelings, and bodily sensations. Through MBCT, patients will learn skills that allow them to disengage from habitual ("automatic") dysfunctional cognitive routines, such as obsessional thinking. As an example, patients are encouraged to relate to thoughts and feelings as passing events in the mind, rather than to identify with them or treat them as accurate representations of reality. The MBCT protocol for OCD patients is adapted from Segal et al.'s original MBCT manual for depression (Segal, Williams & Teasdale, 2002).
Primary Outcome Measure Information:
Title
Change in Symptom Severity from Baseline in OCD Measures
Description
OCD measures will include: a self-report version of the Yale-Brown Obsessive Compulsive Scale (YBOCS-SR), the Obsessive Compulsive Inventory -Revised (OCI-R), consisting of six subscales (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralising), and the Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Change in Level of Impairment from Baseline
Description
The Sheehan Disability Scale will be used to measure level of functional impairment in three inter-related domains (work/school, social and family life).
Time Frame
10 weeks
Title
Change in Mood from Baseline
Description
The Beck Depression Inventory -II (BDI-II), will be used to assess depression severity.
Time Frame
10 weeks
Title
Change in Mindfulness from Baseline
Description
Mindfulness measures include: The Five Facet Mindfulness Questionnaire (FFMQ), used to measure the five constructs central to mindfulness (Observing, Describing, Acting with Awareness, Non-judgment of Inner Experience, and Non-reactivity to Inner Experience), and the the Self-Compassion Scale-Short Form (SCS-SF) measuring 6 components of self-compassion (Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness & Over-Identification).
Time Frame
10 weeks
Title
Retention of Gains at Follow-up
Description
All self-report measures will be re-administered at 6-week follow-up to measure robustness of gains post-treatment.
Time Frame
16 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre at Sunnybrook Health Sciences Centre
Primary Diagnosis of OCD
Ability to communicate in written and spoken English
Exclusion Criteria:
Those with active substance abuse/dependence within 3 months
Suspected organic pathology
Recent suicide attempt/active suicidality
Current self-injurious behaviour
Active bipolar or psychotic disorder
Previous completion of an MBCT course (≥ 8 weeks)
Previous completion of an OCD-specific course of CBT (≥ 8 weeks)
Previous completion of a general course of CBT (≥ 8 weeks) in the past 3 years
Facility Information:
Facility Name
The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
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Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
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