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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03128749
• Other study ID #: CorporacionPT CIR2016/030
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2017
• Last updated: January 12, 2018
• Start date: January 11, 2018
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Corporacion Parc Tauli
• Contact: Clara López-Solà, PhD
• Phone: 0034 93 723 10 10
• Email: clopezs[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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).

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

Locations

Country	Name	City	State
Spain	Corporacion Sanitaria Parc Taulí	Sabadell	Barcelona

Sponsors (4)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Children's Hospital Medical Center, Cincinnati, Hospital Universitari de Bellvitge, University of Arizona

Country where clinical trial is conducted

Spain, 

References & Publications (18)

Benzina N, Mallet L, Burguière 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. Review. — View Citation

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. — View Citation

Brooks SJ, Naidoo V, Roos A, Fouché 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. — View Citation

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. Review. — View Citation

Goldberg X, Soriano-Mas C, Alonso P, Segalàs C, Real E, López-Solà C, Subirà M, Via E, Jiménez-Murcia S, Menchón 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. — View Citation

Göttlich M, Krämer 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

López-Solà C, Fontenelle LF, Verhulst B, Neale MC, Menchón 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. — View Citation

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. — View Citation

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. Epub 2007 Oct 17. Review. — View Citation

Murray CJ, Lopez AD. Evidence-based health policy--lessons from the Global Burden of Disease Study. Science. 1996 Nov 1;274(5288):740-3. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Change in anxiety:	• Anxiety Sensitivity Index (ASI-3)	Baseline and at 14 weeks
Secondary	Change in mood from baseline:	• The Beck Depression Inventory (BDI-II)	Baseline, at 14 weeks and at 6 months post-treatment
Secondary	Change in positive and negative affect:	• Positive and Negative Affect trait (PANAS)	Baseline and at 14 weeks
Secondary	Impact of current life events:	• Perceived Stress Scale (PSS)	Baseline, 14 weeks and at 6 months post-treatment
Secondary	Impact of past stressful life events:	• Childhood Trauma Questionnaire (CTQ)	Baseline
Secondary	Change in attentional domains:	• Conners' Continuous Performance Test II : CPT-II	Baseline and at 14 weeks
Secondary	Change in executive Functioning/Cognitive flexibility:	• Wisconsin Card Sorting Test: WCST	Baseline and at 14 weeks
Secondary	Autobiographical memories:	• Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).	Baseline
Secondary	Change in verbal fluency:	• Phonetic Fluency: PMR (Spanish version of the FAS)	Baseline, 14 weeks and at 6 months post-treatment
Secondary	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.	Baseline
Secondary	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.	Baseline, each week during the treatment period (10 sessions) and post-treatment
Secondary	Change in Quality of Life:	• Multicultural Quality of Life Index (MQLI).	Baseline, 14 weeks and at 6 months post-treatment
Secondary	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).	Baseline, 14 weeks and at 6 months post-treatment
Secondary	Change in Rumination:	• Ruminative Responses Scale (RRS) to measure the degree and type of thought thinking.	Baseline, 14 weeks and at 6 months post-treatment
Secondary	Treatment expectancy:	• Credibility Expectancy Questionnaire (CEQ).	Baseline
Secondary	Changes in structural brain regions:	• Structural acquisition: T13D	Baseline and at 14 weeks