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

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

Sponsors

Lead Sponsor: Corporacion Parc Tauli

Collaborator: Hospital Universitari de Bellvitge
Children's Hospital Medical Center, Cincinnati
University of Arizona

Source 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.

Overall Status Unknown status
Start Date 2018-01-11
Completion Date 2018-12-01
Primary Completion Date 2018-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Y-BOCS: Baseline and at 14 weeks and at 6 months post-treatment
Change in OCI-R: Baseline, at 14 weeks and at 6 months post-treatment
Change in OBQ-44: Baseline and at 14 weeks
Changes in functional brain circuits: Baseline and at 14 weeks
Secondary Outcome
Measure Time Frame
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
Change in attentional domains: Baseline and at 14 weeks
Change in executive Functioning/Cognitive flexibility: Baseline and at 14 weeks
Autobiographical memories: Baseline
Change in verbal fluency: Baseline, 14 weeks and at 6 months post-treatment
Speech analysis: Baseline
Thought content: Baseline, each week during the treatment period (10 sessions) and post-treatment
Change in Quality of Life: Baseline, 14 weeks and at 6 months post-treatment
Change in Mindfulness variables: Baseline, 14 weeks and at 6 months post-treatment
Change in Rumination: Baseline, 14 weeks and at 6 months post-treatment
Treatment expectancy: Baseline
Changes in structural brain regions: Baseline and at 14 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Mindfulness Based 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).

Arm Group Label: Mindfulness Based Intervention

Other Name: MBCT

Intervention Type: Drug

Intervention Name: Treatment as Usual

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

Other Name: TAU

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

No

Overall Official
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Status: Contact: Contact Backup: Corporacion Sanitaria Parc Taulí Clara Lopez-Solà, PhD 600458159 [email protected]
Location Countries

Spain

Verification Date

2018-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Corporacion Parc Tauli

Investigator Full Name: Clara López-Solà

Investigator Title: PhD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mindfulness Based Intervention

Type: Experimental

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.

Label: Treatment as Usual (TAU)

Type: Active Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: Double (Care Provider, Outcomes Assessor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obsessive-Compulsive Disorder

Clinical Trials on Mindfulness Based Intervention