Obsessive-Compulsive DisorderNCT02217995
Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
A study testing Mindfulness-Based Cognitive Therapy (MBCT) in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Mindfulness-Based Cognitive Therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Pilot Randomized Trial Testing Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Mindfulness-Based Cognitive Therapy (MBCT)
- Keywords
- Mindfulness-Based Cognitive Therapy, Mindfulness
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive Therapy (MBCT)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group. Receives: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| Waitlist | No intervention | Wait list as per usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks
Secondary outcomes (4)
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).
Measured: 10 weeks
Change in Mood from Baseline
The Beck Depression Inventory -II (BDI-II), will be used to assess depression severity.
Measured: 10 weeks
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).
Measured: 10 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Neil Rector, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217995
- Sponsor's protocol ID
- 138-2014
- Status last verified
- Sep 2018
- First submitted
- 13 Aug 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial Testing Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients
- ClinicalTrials.gov ID
- NCT02217995
- Acronym / sponsor ID
- 138-2014
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Mindfulness-Based Cognitive Therapy, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group. |
| Waitlist | No intervention | –Wait list as per usual. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT)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). | Behavioural | Mindfulness-Based Cognitive Therapy (MBCT) |
Primary outcome
Change in Symptom Severity from Baseline in OCD Measures
Time frame: 10 weeks
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)
4 secondary outcomes
Change in Level of Impairment from Baseline
Time frame: 10 weeks
Change in Mood from Baseline
Time frame: 10 weeks
Change in Mindfulness from Baseline
Time frame: 10 weeks
Retention of Gains at Follow-up
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy (MBCT) in people with Obsessive-Compulsive Disorder, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Severity from Baseline in OCD Measures (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.