Clinical trial NCT04914923: Mindfulness-Based Interventions for OCD
Official title: Mindfulness-Based Interventions for OCD: Efficacy, Mechanisms, and Biological Predictors of Outcome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Cognitive Behaviour Therapy
Mindfulness-based Intervention
Mindfulness-based cognitive therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: McMaster University
First posted: 2021-06-07
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment-seeking participants at Sunnybrook Health Sciences Centre (SHSC) and St. Joseph's Healthcare Hamilton, McMaster University (McMaster) with a primary DSM-5 diagnosis of OCD will be randomly assigned to receive a: 1) 12-week MBCT group intervention, 2) a 12-week CBT intervention or 3) a 12-week waitlist condition and will complete repeated assessments at baseline, throughout treatment, at post-treatment and three-month follow-up
Primary purpose: TREATMENT

Brief summary: Obsessive-compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting about 2% of the population. It is characterized by the presence of recurrent obsessions and/or compulsions that are time consuming and cause marked distress and/or impairment. Untreated, OCD runs a chronic and deteriorating course. According to the World Health Organization, OCD is among the top 10 leading causes of disability worldwide. Examination of non-medicinal treatments for OCD has focused on two distinct treatments: exposure and response prevention (ERP) and cognitive therapy (CT), often combined into an integrated cognitive-behavioural treatment (CBT). CBT is considered the first line psychological treatment for OCD, with estimates of response rates of between 70-80%. However, there are a significant number of treatment non-responders and the majority of responders are still left with impairing residual symptoms. One area of investigation that has shown potential benefit for general mood and anxiety disorders has been mindfulness-based interventions (MBIs), yet the potential benefits of MBIs in OCD has been largely unexamined, except for several small preliminary studies that show clinical promise. The purpose of this study is to examine the clinical benefits of a standardized MBI treatment for OCD in a large-scale, multi-site randomized controlled trial. The results of this study will directly determine whether Mindfulness can be considered an effective treatment for OCD. If this study can demonstrate that a short-term mindfulness intervention can significantly reduce the suffering associated with OCD, then the findings could easily be translated into routine clinical care in and out of hospital settings. Results of this study will also potentially add to our understanding of the mechanisms that drive OCD symptoms, improve our knowledge of psychological treatment mechanisms, and elucidate how biological factors influence psychological treatment outcomes.

Detailed description: Cognitive Behavioural Therapy (CBT) is a first line psychological treatment for OCD with estimated response rates of between 70-80%. However, there are still a substantial number of treatment non-responders and the vast majority of responders are left with impairing residual symptoms. One new area of investigation that has shown potential benefit for the treatment of OCD has been mindfulness-based interventions (MBIs). This emerging literature provides proof of principle for the delivery and potential efficacy of MBIs for OCD, particularly as an adjunct to CBT, with all studies reporting large (d \> .80) treatment effects. To date, only our teams' small, non-controlled pilot study (N=19) has shown promise for a MBI as a stand-alone treatment for OCD separate from CBT (d = 1.10). However, all results to date for MBI treatments for OCD must be interpreted with caution as they have utilized small, underpowered sample sizes, have not included control groups, and failed to control for potentially confounding variables (e.g., medications, self-initiated exposures). The proposed four-year, two-site randomized controlled trial at two of Canada's leading OCD treatment centres (Sunnybrook Health Sciences Centre and St. Joseph's Healthcare Hamilton) that have been involved in developing and piloting MBI treatments for OCD will aim to test whether a structured, Mindfulness-Based Cognitive Therapy (MBCT) intervention for OCD is an efficacious treatment for a large, heterogeneous sample of DSM-5 (Diagnostic Statistical Manual of Mental Disorders 5th edition) diagnosed OCD participants. The primary aim of this proposed study is to examine whether a developed and piloted MBCT treatment for OCD is efficacious when compared to a waitlist condition and to explore its efficacy compared to CBT treatment for OCD. A secondary aim of the study is to examine the putative treatment mechanisms of MBCT. Past research examining treatment mechanisms in CBT for OCD have focused on the reduction of obsessional beliefs, anxiety sensitivity, and safety behaviours in producing better outcomes. In contrast, the hypothesized mechanisms in MBI treatments include the development of mindfulness skills such as acting with awareness, non-reactivity to and non-judging of inner experience, and reduction in mind wandering. The large-scale, powered RCT (randomized control trial) design will permit the examination of whether MBCT and CBT include overlapping or distinct treatment mechanisms. Treatment outcomes will be assessed with standardized measures of OCD symptomatology, general measures of mood and anxiety, a reliable and valid EEG measure to assess cognitive changes across treatment. If this study can demonstrate that a short-term mindfulness intervention can significantly reduce the suffering associated with OCD, then the findings could easily be translated into routine clinical care in and out of Canadian hospital settings. Results of this study will also potentially add to our understanding of the mechanisms that drive OCD symptoms, improve our knowledge of psychological treatment mechanisms, and elucidate how genetic/biological factors influence psychological treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* experiencing clinically significant obsessive-compulsive symptoms based on the Yale-Brown Obsessive Compulsive Scale (YBOCS; score \> 17)
* if on medications for OCD, must be stabilized, i.e. are currently receiving an adequate dose (equivalent of 40mg/day of fluoxetine) for an adequate duration (at least 8 weeks of treatment) prior to the initiation of the study.

Exclusion Criteria:

* concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
* suspected organic pathology
* an active comorbid medical condition that may require urgent intervention during the treatment.

Primary outcomes:
measure: Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change from baseline in OCD symptomatology, as measured by the OCI-R (Obsessive Compulsive Inventory - Revised).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in the experience of depression, anxiety and stress symptoms, as measured by the DASS-21 (Depression, Anxiety and Stress Scale - 21 items).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in various attitudes and beliefs related to obsessional thoughts, as measured by the OBQ-44 (Obsessional Beliefs Questionnaire - 44 items).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in aspects of mindfulness, as measured by the FFMQ (Five Facet Mindfulness Questionnaire).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in functional health and well-being, as measured by the SF-36 Health Survey (Short Form 36 item Health Survey).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in the degree which individuals find distress intolerable, as measured by the DTS (Distress Tolerance Scale).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in the fear of consequences of anxiety, as measured by the ASI-3 (Anxiety Sensitivity Index).
timeFrame: Baseline to 12 weeks
measure: Change from baseline in the time spent ruminating, as measured by the RRS (Ruminative Response Scale).
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Change from baseline in OCD symptomatology, as measured by the EEG headset device "Muse".
timeFrame: Baseline to 12 weeks
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Neil A Rector, PhD
role: PRINCIPAL_INVESTIGATOR
References: