Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients

Lead Sponsor: Corporacion Parc Tauli

Collaborator: Hospital Universitari de Bellvitge
Children's Hospital Medical Center, Cincinnati
University of Arizona

Obsessive-Compulsive Disorder (OCD) patients have a response rate of 50-60% to exposure and response prevention (ERP) therapy and SSRI antidepressants. Mindfulness-Based Cognitive Therapy (MBCT) consists of training the participant to non-react to negative thoughts and emotions. Applying MBCT to OCD patients may help them behave with equanimity in response to their obsessions, and therefore acknowledge them with the same attention and intention as they admit any other disturbing thought without reacting to it. MBCT has demonstrated effectiveness in major depression, but much less attention has been given to MBCT in OCD. ERP and MBCT, although sharing aspects like exposure, are based on different theoretic and therapeutic factors. EPR is based on a direct anxiety habituation process whereas MBCT trains a holistic manner of becoming familiarized with distressful thoughts and emotions while learning to develop a new relationship to them. Thus, MBCT may decrease anxiety indirectly through a major attention awareness and non-reactivity to thoughts and emotions. OCD is characterized by altered cortical-striatal-thalamic-cortical (CSTC) circuit and default mode network (DMN) connectivity when performing different tasks and during the resting state. It has been establish that the ventral CSTC circuit is mostly associated with emotional processing, while the dorsolateral aspect of the CSTC circuit is preferentially involved in cognitive processing. In this regard, we hypothesized that clinical amelioration will be accompanied by a re-establishment of functional connectivity within dorsolateral and DMN circuits, which will in turn be associated with improvement of certain neuropsychological processes. CSTC and DMN circuits have also shown to be sensitive to prolonged stress situations. Specifically, childhood trauma has been related to larger brain volumes and it has been associated with different OCD clinical subtypes. Aims: 1. To assess MBCT effectiveness in treatment non-naive OCD patients. 2. To study cognitive and neuropsychological characteristics that mediate or moderate MBCT response. 3. To examine the changes in cognitive, neuropsychological and neuroimaging patterns associated with an MBCT intervention. 4. To identify a brain biomarker for positive response to MBCT in non-naïve OCD patients. 5. To study cognitive, neuropsychological and early stress expousure mediators or moderators of functional changes in CSTC and DMN patterns in response to MBCT.

• Obsessive-Compulsive Disorder

Intervention Type: Behavioral

Intervention Name: Mindfulness Based Intervention

Description: The mindfulness based intervention protocol used in this project is adapted from the original and validated MBCT program for depression (Segal, Williams & Teasdale, 2002). Two more sessions, focused on obsessive symptoms specfic to each participant, will be included. Those two sessions will be adapted from the manual "The Mindfulness Workbook for OCD" (Hershfield and Corboy, 2013).

Arm Group Label: Mindfulness Based Intervention

Other Name: MBCT

Intervention Type: Drug

Intervention Name: Treatment as Usual

Description: The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.

Other Name: TAU

Criteria:

Inclusion Criteria: - Age frame: 18-50 years old. - Principal Diagnosis: Obsessive compulsive disorder. - Severity of OCD symptoms: between mild (Y-BOCS=9) and severe (Y-BOCS=32) - Previous structured CBT or EPR, either in group or individual format, between 10 to 20 sessions. - A maximum of three different pharmacological strategies. - Minimum of IQ 85 measured by Vocabulary subtest (WAIS-IV). - Minimum level of schooling: 14 years. - To sign the informant consent. Exclusion Criteria: - Organic pathology and/or neurological disorders such as brain injury or epilepsy. - Comorbidity with: Mental Retardation, previous or current substance abuse, psychotic disorders, bipolar disorder. Other affective and/or anxiety disorders will not be an exclusion criteria if OCD is considered the primary diagnosis. - Recent suicide attempt/active suicidality - Previous completion of an MBCT course (≥ 8 weeks)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

No

Spain

2018-01-01

Type: Principal Investigator

Investigator Affiliation: Corporacion Parc Tauli

Investigator Full Name: Clara López-Solà

Investigator Title: PhD

• Obsessive-Compulsive Disorder
• Mindfulness Based Intervention
• Cognitive-Behavioral Therapy
• Functional Magnetic Resonance Imaging
• Neuropsychology
• Childhood Maltreatment

• Compulsive Personality Disorder
• Obsessive-Compulsive Disorder

Label: Mindfulness Based Intervention

Type: Experimental

Description: Mindfulness-based cognitive therapy (MBCT), adjusted to OCD patients, will be applied in 10 weekly sessions of 2 hours followed by an extra session 4 weeks later. The treatment will be applied in a group format of 10 to 12 patients. These patients will be also attending to their regular psychiatric visits for medication control.

Label: Treatment as Usual (TAU)

Type: Active Comparator

Description: Patients will be attending to their regular psychiatric visits during the whole trial period.

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: Double (Care Provider, Outcomes Assessor)