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

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ClinicalTrials.gov Identifier: NCT03128749
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
Hospital Universitari de Bellvitge
Children's Hospital Medical Center, Cincinnati
University of Arizona
Information provided by (Responsible Party):
Clara López-Solà, 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.


Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Mindfulness Based Intervention Drug: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients Non-responders to CBT
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.

Behavioral: Mindfulness Based Intervention
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).
Other Name: MBCT

Drug: Treatment as Usual
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Other Name: TAU

Active Comparator: Treatment as Usual (TAU)
Patients will be attending to their regular psychiatric visits during the whole trial period.
Drug: Treatment as Usual
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Other Name: TAU




Primary Outcome Measures :
  1. Change in Y-BOCS: [ Time Frame: 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.

  2. Change in OCI-R: [ Time Frame: 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).

  3. Change in OBQ-44: [ Time Frame: 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).

  4. Changes in functional brain circuits: [ Time Frame: 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 :
  1. Change in anxiety: [ Time Frame: Baseline and at 14 weeks ]
    • Anxiety Sensitivity Index (ASI-3)

  2. Change in mood from baseline: [ Time Frame: Baseline, at 14 weeks and at 6 months post-treatment ]
    • The Beck Depression Inventory (BDI-II)

  3. Change in positive and negative affect: [ Time Frame: Baseline and at 14 weeks ]
    • Positive and Negative Affect trait (PANAS)

  4. Impact of current life events: [ Time Frame: Baseline, 14 weeks and at 6 months post-treatment ]
    • Perceived Stress Scale (PSS)

  5. Impact of past stressful life events: [ Time Frame: Baseline ]
    • Childhood Trauma Questionnaire (CTQ)

  6. Change in attentional domains: [ Time Frame: Baseline and at 14 weeks ]
    • Conners' Continuous Performance Test II : CPT-II

  7. Change in executive Functioning/Cognitive flexibility: [ Time Frame: Baseline and at 14 weeks ]
    • Wisconsin Card Sorting Test: WCST

  8. Autobiographical memories: [ Time Frame: Baseline ]
    • Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).

  9. Change in verbal fluency: [ Time Frame: Baseline, 14 weeks and at 6 months post-treatment ]
    • Phonetic Fluency: PMR (Spanish version of the FAS)

  10. Speech analysis: [ Time Frame: 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.

  11. Thought content: [ Time Frame: 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.

  12. Change in Quality of Life: [ Time Frame: Baseline, 14 weeks and at 6 months post-treatment ]
    • Multicultural Quality of Life Index (MQLI).

  13. Change in Mindfulness variables: [ Time Frame: 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).

  14. Change in Rumination: [ Time Frame: Baseline, 14 weeks and at 6 months post-treatment ]
    • Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.

  15. Treatment expectancy: [ Time Frame: Baseline ]
    • Credibility Expectancy Questionnaire (CEQ).

  16. Changes in structural brain regions: [ Time Frame: Baseline and at 14 weeks ]
    • Structural acquisition: T13D



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128749


Contacts
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Contact: Clara López-Solà, PhD 0034 93 723 10 10 ext 22152 clopezs@tauli.cat
Contact: Maria Serra-Blasco, PhD 0034 93 723 10 10 ext 22068 mserrab@tauli.cat

Locations
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Spain
Corporacion Sanitaria Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08001
Contact: Clara Lopez-Solà, PhD    600458159    clopezs@tauli.cat   
Contact: Maria Serra-Blasco, PhD       mariaserrblasco@gmail.com   
Sponsors and Collaborators
Corporacion Parc Tauli
Hospital Universitari de Bellvitge
Children's Hospital Medical Center, Cincinnati
University of Arizona
Investigators
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Principal Investigator: Clara López-Solà, PhD Corporació Parc Taulí
Principal Investigator: Maria Serra-Blasco, PhD Fundació Parc Taulí
Principal Investigator: Pino Alonso, MD, PhD Bellvitge University Hospital
Principal Investigator: Marina López-Solà, PhD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Jessica Andrews-Hanna, PhD University of Arizona

Publications:
Segal ZV, Williams JMG, Teasdale JD (2002) Mindfulness-based cognitive therapy for depression: a new approach to preventing relapse. Guilford, New York.

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Responsible Party: Clara López-Solà, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT03128749     History of Changes
Other Study ID Numbers: CorporacionPT CIR2016/030
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clara López-Solà, Corporacion Parc Tauli:
Obsessive-Compulsive Disorder
Mindfulness Based Intervention
Cognitive-Behavioral Therapy
Functional Magnetic Resonance Imaging
Neuropsychology
Childhood Maltreatment

Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders