Obsessive-Compulsive DisorderNCT03128749
Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients
A study testing Mindfulness Based Intervention and Treatment as Usual in people with Obsessive-Compulsive Disorder, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Mindfulness Based Intervention and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Corporacion Sanitaria Parc Taulí
Sabadell, Barcelona, 08001
Clara Lopez-Solà, PhD, 600458159, clopezs@tauli.cat
Maria Serra-Blasco, PhD, mariaserrblasco@gmail.com
About this study
Official title: Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients Non-responders to CBT
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
- Being tested
- Mindfulness Based Intervention, Treatment as Usual
- Keywords
- Obsessive-Compulsive Disorder, Mindfulness Based Intervention, Cognitive-Behavioral Therapy, Functional Magnetic Resonance Imaging, Neuropsychology, Childhood Maltreatment
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based InterventionBehavioural
Also called MBCT
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 called TAU
The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Y-BOCS:
- Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline and at 14 weeks
Secondary outcomes (16)
Change in anxiety:
- Anxiety Sensitivity Index (ASI-3)
Measured: Baseline and at 14 weeks
Change in mood from baseline:
- The Beck Depression Inventory (BDI-II)
Measured: Baseline, at 14 weeks and at 6 months post-treatment
Change in positive and negative affect:
- Positive and Negative Affect trait (PANAS)
Measured: Baseline and at 14 weeks
Impact of current life events:
- Perceived Stress Scale (PSS)
Measured: Baseline, 14 weeks and at 6 months post-treatment
Impact of past stressful life events:
- Childhood Trauma Questionnaire (CTQ)
Measured: Baseline
Change in attentional domains:
- Conners' Continuous Performance Test II : CPT-II
Measured: Baseline and at 14 weeks
Change in executive Functioning/Cognitive flexibility:
- Wisconsin Card Sorting Test: WCST
Measured: Baseline and at 14 weeks
Autobiographical memories:
- Autobiographic Memory Task: 10 selected emotions (5 negative and 5 positive).
Measured: Baseline
Change in verbal fluency:
- Phonetic Fluency: PMR (Spanish version of the FAS)
Measured: 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.
Measured: 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.
Measured: Baseline, each week during the treatment period (10 sessions) and post-treatment
Change in Quality of Life:
- Multicultural Quality of Life Index (MQLI).
Measured: 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).
Measured: 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.
Measured: Baseline, 14 weeks and at 6 months post-treatment
Treatment expectancy:
- Credibility Expectancy Questionnaire (CEQ).
Measured: Baseline
Changes in structural brain regions:
- Structural acquisition: T13D
Measured: Baseline and at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start11 Jan 2018
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Children's Hospital Medical Center, Cincinnati, University of Arizona
- Responsible party
- Principal investigator, Clara López-Solà, Corporacion Parc Tauli
- Investigators
- Clara López-Solà, PhD, Principal investigator, Corporació Parc TaulíMaria Serra-Blasco, PhD, Principal investigator, Fundació Parc TaulíPino Alonso, MD, PhD, Principal investigator, Hospital Universitari de BellvitgeMarina López-Solà, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiJessica Andrews-Hanna, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128749
- Sponsor's protocol ID
- CorporacionPT CIR2016/030
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8077177Murray 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.
PubMed 8966556Lopez-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.
PubMed 26630089Rufer 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.
PubMed 16603035Mataix-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.
PubMed 12207105Whittal 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.
PubMed 19045968Houghton 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.
PubMed 19849894Jain 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.
PubMed 17291166Benzina 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.
PubMed 27423459Chiesa 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.
PubMed 24503749Radua 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.
PubMed 19880927Menzies 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.
PubMed 18061263Beucke 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.
PubMed 25257066Gottlich 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.
PubMed 26388257Segal ZV, Williams JMG, Teasdale JD (2002) Mindfulness-based cognitive therapy for depression: a new approach to preventing relapse. Guilford, New York.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Cognitive Therapy: Efficacy and fMRI-based Response Predictors in a Group of OCD Patients Non-responders to CBT
- ClinicalTrials.gov ID
- NCT03128749
- Acronym / sponsor ID
- CorporacionPT CIR2016/030
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Mindfulness Based Intervention, Cognitive-Behavioral Therapy, Functional Magnetic Resonance Imaging, Neuropsychology, Childhood Maltreatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Hospital Universitari de Bellvitge, Children's Hospital Medical Center, Cincinnati, University of Arizona
- Study start
- 11 Jan 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Behavioral: Mindfulness Based Intervention, Drug: Treatment as UsualMindfulness-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. |
| Treatment as Usual (TAU) | Active comparator | Drug: Treatment as UsualPatients will be attending to their regular psychiatric visits during the whole trial period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based InterventionAlso: MBCTThe 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). | Behavioural | Mindfulness Based Intervention |
| Treatment as UsualAlso: TAUThe psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed. | Drug | Mindfulness Based Intervention, Treatment as Usual (TAU) |
Primary outcome
Change in Y-BOCS:
Time frame: Baseline and at 14 weeks and at 6 months post-treatment
• Clinical version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) the severity and the checklist.
Change in OCI-R:
Time frame: Baseline, at 14 weeks and at 6 months post-treatment
• Obsessive-Compulsive Inventory-Revised (OCI-R) assessing 6 dimensions (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing).
Change in OBQ-44:
Time frame: Baseline and at 14 weeks
• Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation).
Changes in functional brain circuits:
Time frame: Baseline and at 14 weeks
• Functional Magnetic Resonance Imaging: Resting state and during task performance (Autobiographical memory + N-Back) and self-reference.
16 secondary outcomes
Change in anxiety:
Time frame: Baseline and at 14 weeks
Change in mood from baseline:
Time frame: Baseline, at 14 weeks and at 6 months post-treatment
Change in positive and negative affect:
Time frame: Baseline and at 14 weeks
Impact of current life events:
Time frame: Baseline, 14 weeks and at 6 months post-treatment
Impact of past stressful life events:
Time frame: Baseline
Change in attentional domains:
Time frame: Baseline and at 14 weeks
Change in executive Functioning/Cognitive flexibility:
Time frame: Baseline and at 14 weeks
Autobiographical memories:
Time frame: Baseline
Change in verbal fluency:
Time frame: Baseline, 14 weeks and at 6 months post-treatment
Speech analysis:
Time frame: Baseline
Thought content:
Time frame: Baseline, each week during the treatment period (10 sessions) and post-treatment
Change in Quality of Life:
Time frame: Baseline, 14 weeks and at 6 months post-treatment
Change in Mindfulness variables:
Time frame: Baseline, 14 weeks and at 6 months post-treatment
Change in Rumination:
Time frame: Baseline, 14 weeks and at 6 months post-treatment
Treatment expectancy:
Time frame: Baseline
Changes in structural brain regions:
Time frame: Baseline and at 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 8077177Weissman 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.
- Background: PubMed 8966556Murray 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.
- Background: PubMed 26630089Lopez-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.
- Background: PubMed 16603035Rufer 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.
- Background: PubMed 12207105Mataix-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.
- Background: PubMed 19045968Whittal 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.
- Background: PubMed 19849894Houghton 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.
- Background: PubMed 17291166Jain 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.
- Background: PubMed 27423459Benzina 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.
- Background: PubMed 24503749Chiesa 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.
- Background: PubMed 19880927Radua 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.
- Background: PubMed 18061263Menzies 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara López-Solà, PhD principal investigator
Corporació Parc Taulí
Maria Serra-Blasco, PhD principal investigator
Fundació Parc Taulí
Pino Alonso, MD, PhD principal investigator
Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention and Treatment as Usual in people with Obsessive-Compulsive Disorder, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara López-Solà, PhD (0034 93 723 10 10 ext. 22152, clopezs@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Y-BOCS: (time frame: Baseline and at 14 weeks and at 6 months post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03128749, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.