Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06265233
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2024-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ERP Plus Improv Group Therapy for OCD (IMPROVE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-02-09', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% change on the YBOCS.'}], 'secondaryOutcomes': [{'measure': 'Change in Intolerance of Uncertainty Score', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Change in intolerance of uncertainty (IU) will be measured with the Intolerance of Uncertainty Scale - Short Form (IUS-12). IU is the tendency to respond negatively to uncertain situations. The IUS-12 is a 12-item self-report measure that assesses IU. Each item is assessed using a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).\n\nIt consists of two subscales: Prospective IU and Inhibitory IU. Prospective IU is the cognitive appraisal of a threat related to future uncertainty. Inhibitory IU refers to the behavioral inhibition related to uncertainty. The Prospective IU subscale is comprised of 7 items, while the Inhibitory IU subscale is comprised of 5 items. Scores are summed to generate the two subscale scores and a total score. Total IUS-12 scores range from 12 to 60, with higher scores indicating a higher IU.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behavioral Therapy', 'ExRP (Exposure and Response Prevention)', 'ERP', 'Improv comedy', 'OCD'], 'conditions': ['Obsessive-Compulsive Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://med.stanford.edu/rodriguezlab/research.html', 'label': 'Stanford OCD Research Lab Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to pilot test a novel group therapy intervention for adults with OCD.', 'detailedDescription': 'The intervention will incorporate exposure and response prevention (ERP) with improvisational comedy ("improv") activities. ERP is the gold-standard treatment for OCD. Improv comedy is a type of theater in which actors perform without a script. This study aims to evaluate whether the intervention is helpful for reducing OCD symptoms and intolerance of uncertainty (a mechanism maintaining OCD). It will also explore whether the intervention is feasible and acceptable.\n\nDuring the group therapy sessions, participants will engage with improv comedy exercises that have been adapted to function as exposures for different types of OCD. Participants will:\n\n* attend an ERP + improv group therapy intervention (90-minute sessions for 12 weeks)\n* complete homework in-between sessions\n* answer questions\n* complete questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Ability to speak and understand English\n* Clinical diagnosis of obsessive-compulsive disorder (OCD)\n\nExclusion Criteria:\n\n* Current active suicidality\n* Medical or psychiatric illness that could interfere with study participation'}, 'identificationModule': {'nctId': 'NCT06265233', 'briefTitle': 'ERP Plus Improv Group Therapy for OCD (IMPROVE Study)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Study of Cognitive Behavioral Therapy (CBT) Plus Improv Group Therapy for OCD', 'orgStudyIdInfo': {'id': '69668'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ERP combined with Improv Group Therapy', 'description': 'Participants will attend 90-minute ERP + improv group therapy sessions for 12 consecutive weeks. They will also complete homework between sessions, answer questions, and complete questionnaires.', 'interventionNames': ['Other: Group Improv sessions', 'Behavioral: Group Exposure and Response Prevention (ERP) Therapy']}], 'interventions': [{'name': 'Group Improv sessions', 'type': 'OTHER', 'otherNames': ['Improv Comedy'], 'description': 'Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.', 'armGroupLabels': ['ERP combined with Improv Group Therapy']}, {'name': 'Group Exposure and Response Prevention (ERP) Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ERP'], 'description': 'Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.', 'armGroupLabels': ['ERP combined with Improv Group Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': '401 Quarry', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Carolyn Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carolyn Rodriguez', 'investigatorAffiliation': 'Stanford University'}}}}