Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients
- Conditions
- Obsessive-Compulsive Disorder
- Interventions
- Behavioral: Mindfulness Based Intervention
- Registration Number
- NCT03128749
- Lead Sponsor
- Corporacion Parc Tauli
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Mindfulness Based Intervention Treatment as Usual 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. Treatment as Usual (TAU) Treatment as Usual Patients will be attending to their regular psychiatric visits during the whole trial period. Mindfulness Based Intervention Mindfulness Based Intervention 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.
- Primary Outcome Measures
Name Time Method Change in Y-BOCS: Baseline and at 14 weeks and at 6 months post-treatment • Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.
Change in OCI-R: Baseline, at 14 weeks and at 6 months post-treatment • Obsessive-Compulsive Inventory-Revised (OCI-R) assessing 6 dimensions (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing).
Change in OBQ-44: Baseline and at 14 weeks • Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation).
Changes in functional brain circuits: Baseline and at 14 weeks • Functional Magnetic Resonance Imaging: Resting state and during task performance (Autobiographical memory + N-Back) and self-reference.
- Secondary Outcome Measures
Name Time Method Change in anxiety: Baseline and at 14 weeks • Anxiety Sensitivity Index (ASI-3)
Impact of current life events: Baseline, 14 weeks and at 6 months post-treatment • Perceived Stress Scale (PSS)
Change in mood from baseline: Baseline, at 14 weeks and at 6 months post-treatment • The Beck Depression Inventory (BDI-II)
Change in positive and negative affect: Baseline and at 14 weeks • Positive and Negative Affect trait (PANAS)
Impact of past stressful life events: Baseline • Childhood Trauma Questionnaire (CTQ)
Change in attentional domains: Baseline and at 14 weeks • Conners' Continuous Performance Test II : CPT-II
Change in executive Functioning/Cognitive flexibility: Baseline and at 14 weeks • Wisconsin Card Sorting Test: WCST
Autobiographical memories: Baseline • Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).
Change in verbal fluency: Baseline, 14 weeks and at 6 months post-treatment • Phonetic Fluency: PMR (Spanish version of the FAS)
Speech analysis: Baseline • 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.
Thought content: Baseline, each week during the treatment period (10 sessions) and post-treatment • 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.
Change in Quality of Life: Baseline, 14 weeks and at 6 months post-treatment • Multicultural Quality of Life Index (MQLI).
Change in Mindfulness variables: Baseline, 14 weeks and at 6 months post-treatment • 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).
Change in Rumination: Baseline, 14 weeks and at 6 months post-treatment • Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.
Treatment expectancy: Baseline • Credibility Expectancy Questionnaire (CEQ).
Changes in structural brain regions: Baseline and at 14 weeks • Structural acquisition: T13D
Trial Locations
- Locations (1)
Corporacion Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain