Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients
NCT ID: NCT03128749
Last Updated: 2018-01-17
Study Results
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Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2018-01-11
2018-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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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.
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).
Treatment as Usual
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Treatment as Usual (TAU)
Patients will be attending to their regular psychiatric visits during the whole trial period.
Treatment as Usual
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Interventions
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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).
Treatment as Usual
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Recent suicide attempt/active suicidality
* Previous completion of an MBCT course (≥ 8 weeks)
18 Years
50 Years
ALL
No
Sponsors
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Hospital Universitari de Bellvitge
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of Arizona
OTHER
Corporacion Parc Tauli
OTHER
Responsible Party
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Clara López-Solà
PhD
Principal Investigators
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Clara López-Solà, PhD
Role: PRINCIPAL_INVESTIGATOR
Corporació Parc Taulí
Maria Serra-Blasco, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundació Parc Taulí
Pino Alonso, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Bellvitge University Hospital
Marina López-Solà, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Jessica Andrews-Hanna, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Corporacion Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Weissman MM, Bland RC, Canino GJ, Greenwald S, Hwu HG, Lee CK, Newman SC, Oakley-Browne MA, Rubio-Stipec M, Wickramaratne PJ, et al. The cross national epidemiology of obsessive compulsive disorder. The Cross National Collaborative Group. J Clin Psychiatry. 1994 Mar;55 Suppl:5-10.
Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science. 1996 Nov 1;274(5288):740-3. doi: 10.1126/science.274.5288.740. No abstract available.
Lopez-Sola C, Fontenelle LF, Verhulst B, Neale MC, Menchon JM, Alonso P, Harrison BJ. DISTINCT ETIOLOGICAL INFLUENCES ON OBSESSIVE-COMPULSIVE SYMPTOM DIMENSIONS: A MULTIVARIATE TWIN STUDY. Depress Anxiety. 2016 Mar;33(3):179-91. doi: 10.1002/da.22455. Epub 2015 Dec 2.
Rufer M, Fricke S, Moritz S, Kloss M, Hand I. Symptom dimensions in obsessive-compulsive disorder: prediction of cognitive-behavior therapy outcome. Acta Psychiatr Scand. 2006 May;113(5):440-6. doi: 10.1111/j.1600-0447.2005.00682.x.
Mataix-Cols D, Marks IM, Greist JH, Kobak KA, Baer L. Obsessive-compulsive symptom dimensions as predictors of compliance with and response to behaviour therapy: results from a controlled trial. Psychother Psychosom. 2002 Sep-Oct;71(5):255-62. doi: 10.1159/000064812.
Whittal ML, Robichaud M, Thordarson DS, McLean PD. Group and individual treatment of obsessive-compulsive disorder using cognitive therapy and exposure plus response prevention: a 2-year follow-up of two randomized trials. J Consult Clin Psychol. 2008 Dec;76(6):1003-14. doi: 10.1037/a0013076.
Houghton S, Saxon D, Bradburn M, Ricketts T, Hardy G. The effectiveness of routinely delivered cognitive behavioural therapy for obsessive-compulsive disorder: a benchmarking study. Br J Clin Psychol. 2010 Nov;49(Pt 4):473-89. doi: 10.1348/014466509X475414. Epub 2009 Oct 21.
Jain S, Shapiro SL, Swanick S, Roesch SC, Mills PJ, Bell I, Schwartz GE. A randomized controlled trial of mindfulness meditation versus relaxation training: effects on distress, positive states of mind, rumination, and distraction. Ann Behav Med. 2007 Feb;33(1):11-21. doi: 10.1207/s15324796abm3301_2.
Benzina N, Mallet L, Burguiere E, N'Diaye K, Pelissolo A. Cognitive Dysfunction in Obsessive-Compulsive Disorder. Curr Psychiatry Rep. 2016 Sep;18(9):80. doi: 10.1007/s11920-016-0720-3.
Chiesa A, Anselmi R, Serretti A. Psychological mechanisms of mindfulness-based interventions: what do we know? Holist Nurs Pract. 2014 Mar-Apr;28(2):124-48. doi: 10.1097/HNP.0000000000000017.
Radua J, Mataix-Cols D. Voxel-wise meta-analysis of grey matter changes in obsessive-compulsive disorder. Br J Psychiatry. 2009 Nov;195(5):393-402. doi: 10.1192/bjp.bp.108.055046.
Menzies L, Chamberlain SR, Laird AR, Thelen SM, Sahakian BJ, Bullmore ET. Integrating evidence from neuroimaging and neuropsychological studies of obsessive-compulsive disorder: the orbitofronto-striatal model revisited. Neurosci Biobehav Rev. 2008;32(3):525-49. doi: 10.1016/j.neubiorev.2007.09.005. Epub 2007 Oct 17.
Beucke JC, Sepulcre J, Eldaief MC, Sebold M, Kathmann N, Kaufmann C. Default mode network subsystem alterations in obsessive-compulsive disorder. Br J Psychiatry. 2014 Nov;205(5):376-82. doi: 10.1192/bjp.bp.113.137380. Epub 2014 Sep 25.
Gottlich M, Kramer UM, Kordon A, Hohagen F, Zurowski B. Resting-state connectivity of the amygdala predicts response to cognitive behavioral therapy in obsessive compulsive disorder. Biol Psychol. 2015 Oct;111:100-9. doi: 10.1016/j.biopsycho.2015.09.004. Epub 2015 Sep 18.
Segal ZV, Williams JMG, Teasdale JD (2002) Mindfulness-based cognitive therapy for depression: a new approach to preventing relapse. Guilford, New York.
Brooks SJ, Naidoo V, Roos A, Fouche JP, Lochner C, Stein DJ. Early-life adversity and orbitofrontal and cerebellar volumes in adults with obsessive-compulsive disorder: voxel-based morphometry study. Br J Psychiatry. 2016 Jan;208(1):34-41. doi: 10.1192/bjp.bp.114.162610. Epub 2015 Sep 3.
Lochner C, du Toit PL, Zungu-Dirwayi N, Marais A, van Kradenburg J, Seedat S, Niehaus DJ, Stein DJ. Childhood trauma in obsessive-compulsive disorder, trichotillomania, and controls. Depress Anxiety. 2002;15(2):66-8. doi: 10.1002/da.10028.
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.
Serra-Blasco M, Miquel-Giner N, Vicent-Gil M, Porta-Casteras D, Martinez-Zalacain I, Cano M, De la Pena-Arteaga V, Mar-Barrutia L, Alemany-Navarro M, Soriano-Mas C, Lopez-Sola M, Andrews-Hanna JR, Portella MJ, Soler J, Cardoner N, Alonso P, Lopez-Sola C. Clinical and Neuroimaging Effects of Mindfulness-Based Cognitive Therapy for Symptomatic OCD Patients after First-Line Treatments: A Randomised Controlled Trial. Psychother Psychosom. 2025 Oct 20:1-32. doi: 10.1159/000548961. Online ahead of print.
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.
Other Identifiers
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CorporacionPT CIR2016/030
Identifier Type: -
Identifier Source: org_study_id
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