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| Name | Class |
|---|---|
| Hospital Universitari de Bellvitge | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Arizona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Treatment as Usual (TAU) | Active Comparator | Patients will be attending to their regular psychiatric visits during the whole trial period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety: | • Anxiety Sensitivity Index (ASI-3) | Baseline and at 14 weeks |
| Change in mood from baseline: | • The Beck Depression Inventory (BDI-II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara López-Solà, PhD | Contact | 0034 93 723 10 10 | 22152 | clopezs@tauli.cat |
| Maria Serra-Blasco, PhD | Contact | 0034 93 723 10 10 | 22068 | mserrab@tauli.cat |
| Name | Affiliation | Role |
|---|---|---|
| Clara López-Solà, PhD | Corporació Parc Taulí | Principal Investigator |
| Maria Serra-Blasco, PhD | Fundació Parc Taulí | Principal Investigator |
| Pino Alonso, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corporacion Sanitaria Parc Taulí | Recruiting | Sabadell | Barcelona | 08001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8077177 | Background | 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. | |
| 8966556 | Background | 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. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Drug | The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed. |
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| Baseline, at 14 weeks and at 6 months post-treatment |
| Change in positive and negative affect: | • Positive and Negative Affect trait (PANAS) | Baseline and at 14 weeks |
| Impact of current life events: | • Perceived Stress Scale (PSS) | Baseline, 14 weeks and at 6 months post-treatment |
| Impact of past stressful life events: | • Childhood Trauma Questionnaire (CTQ) | Baseline |
| Change in attentional domains: | • Conners' Continuous Performance Test II : CPT-II | Baseline and at 14 weeks |
| Change in executive Functioning/Cognitive flexibility: | • Wisconsin Card Sorting Test: WCST | Baseline and at 14 weeks |
| Autobiographical memories: | • Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive). | Baseline |
| Change in verbal fluency: | • Phonetic Fluency: PMR (Spanish version of the FAS) | Baseline, 14 weeks and at 6 months post-treatment |
| 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 |
| 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 |
| Change in Quality of Life: | • Multicultural Quality of Life Index (MQLI). | Baseline, 14 weeks and at 6 months post-treatment |
| 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 |
| 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 |
| Treatment expectancy: | • Credibility Expectancy Questionnaire (CEQ). | Baseline |
| Changes in structural brain regions: | • Structural acquisition: T13D | Baseline and at 14 weeks |
| Hospital Universitari de Bellvitge |
| Principal Investigator |
| Marina López-Solà, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Jessica Andrews-Hanna, PhD | University of Arizona | Principal Investigator |
| 26630089 | Background | 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. |
| 16603035 | Background | 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. |
| 12207105 | Background | 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. |
| 19045968 | Background | 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. |
| 19849894 | Background | 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. |
| 17291166 | Background | 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. |
| 27423459 | Background | 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. |
| 24503749 | Background | 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. |
| 19880927 | Background | 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. |
| 18061263 | Background | 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. |
| 25257066 | Background | 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. |
| 26388257 | Background | 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. |
| Background | Segal ZV, Williams JMG, Teasdale JD (2002) Mindfulness-based cognitive therapy for depression: a new approach to preventing relapse. Guilford, New York. |
| 26338992 | Background | 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. |
| 11891995 | Background | 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. |
| 26172984 | Background | 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. |
| 37839958 | Derived | 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. |