Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients

NCT02217995 | Completed DMC

• 1 other identifier: 138-2014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Mindfulness-Based Cognitive Therapy; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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)

  10 weeks

Secondary Outcomes (4)

• Change in Level of Impairment from Baseline

  10 weeks

• Change in Mood from Baseline

  10 weeks

• Change in Mindfulness from Baseline

  10 weeks

• Retention of Gains at Follow-up

  16 weeks

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group.

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Waitlist

NO INTERVENTION

Wait list as per usual.

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

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).

Mindfulness-Based Cognitive Therapy (MBCT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist and Psychologist

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: September 28, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

CA (1)