Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-28 @ 11:38 PM
Study NCT ID:
NCT04685018
Status:
UNKNOWN
Last Update Posted:
2020-12-28
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Avoidance responses during the avoidance-relief task', 'timeFrame': '1 hour for avoidance task', 'description': 'Avoidance responses during avoidance learning and test will be recorded in terms of button press and Reaction times'}, {'measure': 'Relief during the omissions of the US', 'timeFrame': '1 hour to perform the avoidance task', 'description': 'Relief will be measured as:\n\nBrain data during fMRI: whole-brain activations, as well as activations in specific regions of interest (ROI: VTA, NAcc, OFC) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task;\n\nIndividual ratings: relief pleasantness ratings measured on a Likert scale from 0 (neutral) to 3 (very pleasant) after each omission of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task;\n\nPhysiological data: skin conductance responses (SCR) at the moment of the omissions of the electrical stimulation (US) during both the avoidance learning and the extinction learning phase of the avoidance-relief task.'}], 'secondaryOutcomes': [{'measure': 'Tolerance to stress', 'timeFrame': '1 hour to perform the avoidance task', 'description': 'The individual level of tolerance to distress will be measured via the self-administration of the Distress Tolerance Scale'}, {'measure': 'Therapeutic outcome in OCD', 'timeFrame': '1 hour to perform the avoidance task', 'description': 'The therapeutic outcome in OCD individuals will be evaluated by using the Y-BOCS (self-administered) questionnaire'}, {'measure': 'Resting-state connectivity', 'timeFrame': '1 hour to perform the avoidance task', 'description': 'The strength of connectivity between NAcc, VTA, and OFC, will be measured during the resting state MRI acquisition'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Avoidance behavior', 'Reward', 'Conditioning', 'Extinction', 'Anxiety Disorders', 'OCD', 'fMRI'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'references': [{'pmid': '28457484', 'type': 'RESULT', 'citation': 'Vervliet B, Lange I, Milad MR. Temporal dynamics of relief in avoidance conditioning and fear extinction: Experimental validation and clinical relevance. Behav Res Ther. 2017 Sep;96:66-78. doi: 10.1016/j.brat.2017.04.011. Epub 2017 Apr 23.'}, {'pmid': '23740049', 'type': 'RESULT', 'citation': 'Milad MR, Furtak SC, Greenberg JL, Keshaviah A, Im JJ, Falkenstein MJ, Jenike M, Rauch SL, Wilhelm S. Deficits in conditioned fear extinction in obsessive-compulsive disorder and neurobiological changes in the fear circuit. JAMA Psychiatry. 2013 Jun;70(6):608-18; quiz 554. doi: 10.1001/jamapsychiatry.2013.914.'}, {'pmid': '21490964', 'type': 'RESULT', 'citation': 'Leknes S, Lee M, Berna C, Andersson J, Tracey I. Relief as a reward: hedonic and neural responses to safety from pain. PLoS One. 2011 Apr 7;6(4):e17870. doi: 10.1371/journal.pone.0017870.'}, {'pmid': '23510580', 'type': 'RESULT', 'citation': 'Gillan CM, Morein-Zamir S, Urcelay GP, Sule A, Voon V, Apergis-Schoute AM, Fineberg NA, Sahakian BJ, Robbins TW. Enhanced avoidance habits in obsessive-compulsive disorder. Biol Psychiatry. 2014 Apr 15;75(8):631-8. doi: 10.1016/j.biopsych.2013.02.002. Epub 2013 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the neuro-mechanisms underpinning persistent avoidance in OCD patients', 'detailedDescription': "Many compulsions displayed by obsessive-compulsive disorder (OCD) patients serve to protect against perceived threat and can, therefore, be conceptualized as 'avoidance responses'. Exposure treatment with response prevention (ET+RP) is aimed at exposing patients to their obsessive thoughts and perceived threats while preventing engagement in compulsive avoidant responses. This induces extinction of threat perception and fearful arousal and hence reduces the motivation to avoid. While successful in many patients, however, as much as 40% dropout during treatment or display persistent avoidance after ET+RP. There is a clear need for treatment improvement for these often highly disabled patients.\n\nImproving ET+RP outcomes requires a deeper understanding of the mechanisms that drive excessive and persistent avoidance in OCD patients. Psychological theories ascribe an important role to the relief that follows avoidance when the anticipated threat is successfully averted. This positive feeling arguably functions as a reward to reinforce the foregoing avoidance actions. Indeed, fMRI studies have found that the neurocircuitry of relief overlaps with that of reward, including the ventral tegmental area, ventral striatum and orbitofrontal cortex. Here, the authors will test the hypothesis that excessive-persistent avoidance is linked to exaggerated activation of the relief circuitry in OCD patients. For that purpose, we will acquire functional brain images of OCD patients in an MRI scanner and compare to healthy participants, while they participate in a computer task that is designed to model avoidance learning and relief."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy group: Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition.\n\nOCD group: Same as the healthy group, except for the diagnosis of OCD and medication-free or with a stable medication regimen for at least 3 weeks prior to the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers 18-60 years old;\n* Participants are motivated and give written informed consent;\n* Adequate demand of Dutch language;\n* Subjects have never participated in a fear conditioning task;\n* Diagnosis of OCD (for OCD group only);\n* Contraindications for the MRI exam.\n\nExclusion Criteria:\n\n* Current neurological (e.g. Epilepsia), respiratory, cardiovascular, metabolic, gastrointestinal, endocrine (especially diabetes), renal or urinary diseases, psychiatric disorder or other relevant medical histories (except for OCD in the OCD group);\n* Being pregnant or lactating;\n* Alcohol intake greater than 14 alcoholic units per week (one alcoholic unit = 10 gr ethanol);\n* History of cannabis use or any other drug of abuse during the 3 months prior to the study;\n* The medical doctor has asked to the participant to stay away from stressful situations;\n* Electronic implants (e.g., pacemaker);\n* Pain or other condition of the hand or the wrist.'}, 'identificationModule': {'nctId': 'NCT04685018', 'acronym': 'AvoidOCD', 'briefTitle': 'The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'The Neurocircuitry of Relief During Avoidance Learning in Patients With Obsessive-compulsive Disorder', 'orgStudyIdInfo': {'id': 'bram vervliet'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HC', 'description': 'Mentally and medically healthy adults between 18 and 60 years, free from any current or previous medical or psychiatric condition.', 'interventionNames': ['Device: fMRI acquisition']}, {'label': 'OCD', 'description': 'Adults between 18 and 60 years, with a diagnosis of Obsessive-Compulsive Disorder and medication-free or with stable medication regimen for at least 3 weeks prior to the study.', 'interventionNames': ['Device: fMRI acquisition']}], 'interventions': [{'name': 'fMRI acquisition', 'type': 'DEVICE', 'otherNames': ['Behavioral task'], 'description': 'Participants from the two groups will perform an avoidance-relief task inside an MRI scanner', 'armGroupLabels': ['HC', 'OCD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Bram Vervliet, Prof. Dr.', 'role': 'CONTACT', 'email': 'bram.vervliet@kuleuven.be', 'phone': '+32 16 3 26145'}, {'name': 'Chris Bervoets, Prof. Dr.', 'role': 'CONTACT', 'email': 'chris.bervoets@upckuleuven.be'}, {'name': 'Bram Vervliet', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chris Bervoets', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Psychiatry | UZ Leuven campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Bram Vervliet, Prof. Dr.', 'role': 'CONTACT', 'email': 'bram.vervliet@kuleuven.be', 'phone': '+32 16 3 26 145'}, {'name': 'Chris Bervoets, Prof. Dr.', 'role': 'CONTACT', 'email': 'chris.bervoets@kuleuven.be', 'phone': '+32 16 34 08 77'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator Prof. Dr. Bram Vervliet', 'investigatorFullName': 'Bram Vervliet', 'investigatorAffiliation': 'KU Leuven'}}}}