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

NCT03128749 | Unknown DMC

• 1 other identifier: CorporacionPT CIR2016/030
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Mindfulness Based Intervention; Cognitive-Behavioral Therapy; Functional Magnetic Resonance Imaging; Neuropsychology; Childhood Maltreatment

Outcome Measures

Primary Outcomes (4)

• Change in Y-BOCS:

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

  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).

  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).

  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.

  Baseline and at 14 weeks

Secondary Outcomes (16)

• Change in anxiety:

  Baseline and at 14 weeks

• Change in mood from baseline:

  Baseline, at 14 weeks and at 6 months post-treatment

• Change in positive and negative affect:

  Baseline and at 14 weeks

• Impact of current life events:

  Baseline, 14 weeks and at 6 months post-treatment

• Impact of past stressful life events:

  Baseline

Study Arms (2)

Mindfulness Based Intervention

EXPERIMENTAL

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; Drug: Treatment as Usual

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Drug: Treatment as Usual

Interventions

Mindfulness Based Intervention BEHAVIORAL

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).

Also known as: MBCT

Mindfulness Based Intervention

Treatment as Usual DRUG

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

Also known as: TAU

Mindfulness Based Intervention; Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Organic pathology and/or neurological disorders such as brain injury or epilepsy.
• Recent suicide attempt/active suicidality
• Previous completion of an MBCT course (≥ 8 weeks)

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Hospital Universitari de Bellvitge: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Arizona: collaborator

Study Sites (1)

Corporacion Sanitaria Parc Taulí

Sabadell, Barcelona, 08001, Spain

RECRUITING

Related Publications (19)

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

  BACKGROUND

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• Goldberg X, Soriano-Mas C, Alonso P, Segalas C, Real E, Lopez-Sola C, Subira M, Via E, Jimenez-Murcia S, Menchon JM, Cardoner N. Predictive value of familiality, stressful life events and gender on the course of obsessive-compulsive disorder. J Affect Disord. 2015 Oct 1;185:129-34. doi: 10.1016/j.jad.2015.06.047. Epub 2015 Jul 2.

  PMID: 26172984 BACKGROUND

• Miquel-Giner N, Vicent-Gil M, Martinez-Zalacain I, Porta-Casteras D, Mar L, Lopez-Sola M, Andrews-Hanna JR, Soriano-Mas C, Menchon JM, Cardoner N, Alonso P, Serra-Blasco M, Lopez-Sola C. Efficacy and fMRI-based response predictors to mindfulness-based cognitive therapy in obsessive-compulsive disorder: Study protocol for a randomised clinical trial. Span J Psychiatry Ment Health. 2023 January/March;18(1):6-12. doi: 10.1016/j.rpsm.2022.11.002. Epub 2022 Nov 17. English, Spanish.

  PMID: 37839958 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara López-Solà, PhD

CONTACT

0034 93 723 10 10; clopezs@tauli.cat

Maria Serra-Blasco, PhD

CONTACT

0034 93 723 10 10; mserrab@tauli.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 25, 2017
• Study Start: January 11, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)