Clinical trial NCT02217995: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Mindfulness-Based Cognitive Therapy
Mindfulness
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Symptom Severity from Baseline in OCD Measures
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Level of Impairment from Baseline
timeFrame: 10 weeks
measure: Change in Mood from Baseline
timeFrame: 10 weeks
measure: Change in Mindfulness from Baseline
timeFrame: 10 weeks
measure: Retention of Gains at Follow-up
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: