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

Corporacion Parc Tauli60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Interventions

Mindfulness Based InterventionBEHAVIORAL

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).

Treatment as UsualDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in Y-BOCS:

• Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.

Time frame: Baseline and at 14 weeks and at 6 months post-treatment

Change in OCI-R:

• Obsessive-Compulsive Inventory-Revised (OCI-R) assessing 6 dimensions (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing).

Time frame: Baseline, at 14 weeks and at 6 months post-treatment

Change in OBQ-44:

• Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation).

Time frame: Baseline and at 14 weeks

Changes in functional brain circuits:

• Functional Magnetic Resonance Imaging: Resting state and during task performance (Autobiographical memory + N-Back) and self-reference.

Time frame: Baseline and at 14 weeks

Secondary Outcomes

Change in anxiety:

• Anxiety Sensitivity Index (ASI-3)

Time frame: Baseline and at 14 weeks

Change in mood from baseline:

• The Beck Depression Inventory (BDI-II)

Time frame: Baseline, at 14 weeks and at 6 months post-treatment

Change in positive and negative affect:

• Positive and Negative Affect trait (PANAS)

Time frame: Baseline and at 14 weeks

Impact of current life events:

• Perceived Stress Scale (PSS)

Time frame: Baseline, 14 weeks and at 6 months post-treatment

Impact of past stressful life events:

• Childhood Trauma Questionnaire (CTQ)

Time frame: Baseline

Change in attentional domains:

• Conners' Continuous Performance Test II : CPT-II

Time frame: Baseline and at 14 weeks

Change in executive Functioning/Cognitive flexibility:

• Wisconsin Card Sorting Test: WCST

Time frame: Baseline and at 14 weeks

Autobiographical memories:

• Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).

Time frame: Baseline

Change in verbal fluency:

• Phonetic Fluency: PMR (Spanish version of the FAS)

Time frame: Baseline, 14 weeks and at 6 months post-treatment

Speech analysis:

• Word Task: Assessment of language fluency and thought content using a list of 10 seed words from the Spanish adaptation of the ANEW (Affective Norms for English Words) in terms of positive and negative valance and different degrees of arousal.

Time frame: Baseline

Thought content:

• ES-Questionnaire, designed by Drs. J. Andrews-Hanna and M. López-Solà (research collaborators of the project) from the USA. It is based on 23 questions that examines the thought content from the patient before, during and after the treatment.

Time frame: Baseline, each week during the treatment period (10 sessions) and post-treatment

Change in Quality of Life:

• Multicultural Quality of Life Index (MQLI).

Time frame: Baseline, 14 weeks and at 6 months post-treatment

Change in Mindfulness variables:

• 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).

Time frame: Baseline, 14 weeks and at 6 months post-treatment

Change in Rumination:

• Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.

Time frame: Baseline, 14 weeks and at 6 months post-treatment

Treatment expectancy:

• Credibility Expectancy Questionnaire (CEQ).

Time frame: Baseline

Changes in structural brain regions:

• Structural acquisition: T13D

Time frame: Baseline and at 14 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts