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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness Based Intervention
Treatment as Usual
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Mindfulness Based Intervention, Cognitive-Behavioral Therapy, Functional Magnetic Resonance Imaging, Neuropsychology, Childhood Maltreatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Corporacion Sanitaria Parc TaulíRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Intervention

Treatment as Usual (TAU)

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Y-BOCS:
• Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.
Change in OCI-R:
• Obsessive-Compulsive Inventory-Revised (OCI-R) assessing 6 dimensions (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing).
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).
Changes in functional brain circuits:
• Functional Magnetic Resonance Imaging: Resting state and during task performance (Autobiographical memory + N-Back) and self-reference.

Secondary Outcome Measures

Change in anxiety:
• Anxiety Sensitivity Index (ASI-3)
Change in mood from baseline:
• The Beck Depression Inventory (BDI-II)
Change in positive and negative affect:
• Positive and Negative Affect trait (PANAS)
Impact of current life events:
• Perceived Stress Scale (PSS)
Impact of past stressful life events:
• Childhood Trauma Questionnaire (CTQ)
Change in attentional domains:
• Conners' Continuous Performance Test II : CPT-II
Change in executive Functioning/Cognitive flexibility:
• Wisconsin Card Sorting Test: WCST
Autobiographical memories:
• Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).
Change in verbal fluency:
• Phonetic Fluency: PMR (Spanish version of the FAS)
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.
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.
Change in Quality of Life:
• Multicultural Quality of Life Index (MQLI).
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).
Change in Rumination:
• Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.
Treatment expectancy:
• Credibility Expectancy Questionnaire (CEQ).
Changes in structural brain regions:
• Structural acquisition: T13D

Full Information

First Posted
April 7, 2017
Last Updated
January 12, 2018
Sponsor
Corporacion Parc Tauli
Collaborators
Hospital Universitari de Bellvitge, Children's Hospital Medical Center, Cincinnati, University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03128749
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
Collaborators
Hospital Universitari de Bellvitge, Children's Hospital Medical Center, Cincinnati, University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, Mindfulness Based Intervention, Cognitive-Behavioral Therapy, Functional Magnetic Resonance Imaging, Neuropsychology, Childhood Maltreatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Patients will be attending to their regular psychiatric visits during the whole trial period.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Intervention
Other Intervention Name(s)
MBCT
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).
Intervention Type
Drug
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
TAU
Intervention Description
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Primary Outcome Measure Information:
Title
Change in Y-BOCS:
Description
• 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
Title
Change in OCI-R:
Description
• 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
Title
Change in OBQ-44:
Description
• 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
Title
Changes in functional brain circuits:
Description
• 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 Outcome Measure Information:
Title
Change in anxiety:
Description
• Anxiety Sensitivity Index (ASI-3)
Time Frame
Baseline and at 14 weeks
Title
Change in mood from baseline:
Description
• The Beck Depression Inventory (BDI-II)
Time Frame
Baseline, at 14 weeks and at 6 months post-treatment
Title
Change in positive and negative affect:
Description
• Positive and Negative Affect trait (PANAS)
Time Frame
Baseline and at 14 weeks
Title
Impact of current life events:
Description
• Perceived Stress Scale (PSS)
Time Frame
Baseline, 14 weeks and at 6 months post-treatment
Title
Impact of past stressful life events:
Description
• Childhood Trauma Questionnaire (CTQ)
Time Frame
Baseline
Title
Change in attentional domains:
Description
• Conners' Continuous Performance Test II : CPT-II
Time Frame
Baseline and at 14 weeks
Title
Change in executive Functioning/Cognitive flexibility:
Description
• Wisconsin Card Sorting Test: WCST
Time Frame
Baseline and at 14 weeks
Title
Autobiographical memories:
Description
• Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).
Time Frame
Baseline
Title
Change in verbal fluency:
Description
• Phonetic Fluency: PMR (Spanish version of the FAS)
Time Frame
Baseline, 14 weeks and at 6 months post-treatment
Title
Speech analysis:
Description
• 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
Title
Thought content:
Description
• 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
Title
Change in Quality of Life:
Description
• Multicultural Quality of Life Index (MQLI).
Time Frame
Baseline, 14 weeks and at 6 months post-treatment
Title
Change in Mindfulness variables:
Description
• 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
Title
Change in Rumination:
Description
• Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.
Time Frame
Baseline, 14 weeks and at 6 months post-treatment
Title
Treatment expectancy:
Description
• Credibility Expectancy Questionnaire (CEQ).
Time Frame
Baseline
Title
Changes in structural brain regions:
Description
• Structural acquisition: T13D
Time Frame
Baseline and at 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara López-Solà, PhD
Phone
0034 93 723 10 10
Ext
22152
Email
clopezs@tauli.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Serra-Blasco, PhD
Phone
0034 93 723 10 10
Ext
22068
Email
mserrab@tauli.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara López-Solà, PhD
Organizational Affiliation
Corporació Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Serra-Blasco, PhD
Organizational Affiliation
Fundació Parc Taulí
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pino Alonso, MD, PhD
Organizational Affiliation
Bellvitge University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marina López-Solà, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Andrews-Hanna, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporacion Sanitaria Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08001
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara Lopez-Solà, PhD
Phone
600458159
Email
clopezs@tauli.cat
First Name & Middle Initial & Last Name & Degree
Maria Serra-Blasco, PhD
Email
mariaserrblasco@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients

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