Clinical trial NCT03128749: Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients
Official title: Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients Non-responders to CBT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Mindfulness Based Intervention
Cognitive-Behavioral Therapy
Functional Magnetic Resonance Imaging
Neuropsychology
Childhood Maltreatment
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Hospital Universitari de Bellvitge
name: Children's Hospital Medical Center, Cincinnati
name: University of Arizona
First posted: 2017-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in Y-BOCS:
timeFrame: Baseline and at 14 weeks and at 6 months post-treatment
measure: Change in OCI-R:
timeFrame: Baseline, at 14 weeks and at 6 months post-treatment
measure: Change in OBQ-44:
timeFrame: Baseline and at 14 weeks
measure: Changes in functional brain circuits:
timeFrame: Baseline and at 14 weeks
Secondary outcomes:
measure: Change in anxiety:
timeFrame: Baseline and at 14 weeks
measure: Change in mood from baseline:
timeFrame: Baseline, at 14 weeks and at 6 months post-treatment
measure: Change in positive and negative affect:
timeFrame: Baseline and at 14 weeks
measure: Impact of current life events:
timeFrame: Baseline, 14 weeks and at 6 months post-treatment
measure: Impact of past stressful life events:
timeFrame: Baseline
measure: Change in attentional domains:
timeFrame: Baseline and at 14 weeks
measure: Change in executive Functioning/Cognitive flexibility:
timeFrame: Baseline and at 14 weeks
measure: Autobiographical memories:
timeFrame: Baseline
measure: Change in verbal fluency:
timeFrame: Baseline, 14 weeks and at 6 months post-treatment
measure: Speech analysis:
timeFrame: Baseline
measure: Thought content:
timeFrame: Baseline, each week during the treatment period (10 sessions) and post-treatment
measure: Change in Quality of Life:
timeFrame: Baseline, 14 weeks and at 6 months post-treatment
measure: Change in Mindfulness variables:
timeFrame: Baseline, 14 weeks and at 6 months post-treatment
measure: Change in Rumination:
timeFrame: Baseline, 14 weeks and at 6 months post-treatment
measure: Treatment expectancy:
timeFrame: Baseline
measure: Changes in structural brain regions:
timeFrame: Baseline and at 14 weeks
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporació Parc Taulí
name: Clara López-Solà, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Parc Taulí
name: Maria Serra-Blasco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bellvitge University Hospital
name: Pino Alonso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marina López-Solà, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Jessica Andrews-Hanna, PhD
role: PRINCIPAL_INVESTIGATOR
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