Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-01-06 @ 7:56 PM
Study NCT ID:
NCT02909660
Status:
TERMINATED
Last Update Posted:
2017-12-12
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder
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': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Recruitment difficulties / lack of participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported reassurance seeking behaviour', 'timeFrame': '5 weeks (baseline through 3 week follow-up)', 'description': 'Number of times participants self-report seeking reassurance per day'}, {'measure': 'Self-reported support-seeking behaviour', 'timeFrame': '4 weeks (condition assignment through 3 week follow-up)', 'description': 'Number of times participants in the support-seeking condition self-report seeking reassurance per day'}, {'measure': 'Self-reported anxiety', 'timeFrame': '5 weeks (baseline monitoring through 3 week follow-up)', 'description': 'Level of anxiety on average per day, self-rated from 0-100'}, {'measure': 'One-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)', 'timeFrame': 'One-week follow-up', 'description': 'Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.'}, {'measure': 'One-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)', 'timeFrame': 'One-week follow-up', 'description': 'Validated questionnaire assessing acceptability of and discomfort caused by an intervention.'}, {'measure': 'Three-week follow-up: Treatment Acceptability and Adherence Scale (TAAS; Milosevic, Levy, Alcolado, & Radomsky, 2015)', 'timeFrame': 'Three-week follow-up', 'description': 'Validated questionnaire assessing how acceptable participants find an intervention as well as ease of adherence.'}, {'measure': 'Three-week follow-up: Endorsement and Discomfort Scales (EDS; Tarrier, Liversidge, & Gregg, 2006)', 'timeFrame': 'Three-week follow-up', 'description': 'Validated questionnaire assessing acceptability of and discomfort caused by an intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in self-reported reassurance-seeking', 'timeFrame': 'Baseline to one-week follow-up and baseline to three-week follow-up', 'description': 'Pre-post assessment of change in the number of times per day that participants self-report reassurance seeking behaviour from the baseline monitoring week to the follow-up assessments.'}, {'measure': 'Change in anxiety', 'timeFrame': 'Baseline (monitoring week 1) to end of reassurance provision week (monitoring week 2)', 'description': "Pre-post assessment of change in participants' self-reported anxiety ratings, as rated from 0-100"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obsessive-Compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy and acceptability of two cognitive-behavioural interventions for reassurance seeking behaviour in obsessive-compulsive disorder (OCD), a family accommodation reduction protocol vs. a novel support-seeking protocol. Half of participants will be randomly assigned to participate in the support-seeking intervention, whereas the other half will participate in the family accommodation reduction intervention.', 'detailedDescription': 'An existing family accommodation reduction intervention to reduce reassurance seeking behaviour in OCD (which represents treatment as usual, or TAU) is being compared to a novel support-seeking intervention to determine which is more efficacious and acceptable to participants.\n\nThe TAU protocol asks participants to make an agreement with their significant others to withhold reassurance when it is sought. It is believed that this behaviourally-based intervention encourages extinction of reassurance seeking over time by eliminating reinforcement of the behaviour by significant others.\n\nThe support-seeking intervention asks participants to move towards adaptively seeking support from a significant other to manage anxiety or distress rather than seeking reassurance. Significant others are taught to provide support rather than reassurance. It is believed that support-seeking may reduce reassurance seeking behaviour because it helps participants manage the anxiety or distress that underlies the requests for reassurance without interfering with disconfirmatory learning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of OCD\n* Engaging in reassurance seeking more than once a day about the same thing\n* Willingness to allow the experimenter to contact a significant other from whom the participant seeks reassurance regularly\n* Ability to read, write, and communicate in English\n\nExclusion Criteria:\n\n* Current suicidal ideation/intent\n* Current substance abuse\n* Psychosis\n* Diagnosis of bipolar disorder (I or II)\n* If participants are on medication they must be on a stable dose (i.e., have maintained a consistent dose for at least three months) and agree not to change their medication regimen for the duration of the study'}, 'identificationModule': {'nctId': 'NCT02909660', 'briefTitle': 'What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Concordia University, Montreal'}, 'officialTitle': 'What Are You Looking for? Psychometric and Experimental Analyses of Reassurance Seeking in Obsessive-compulsive Disorder', 'orgStudyIdInfo': {'id': '30006114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Support-seeking intervention', 'description': "Cognitive-behavioural therapy intervention that guides participants to seek support rather than reassurance; participants' significant others are asked to provide support rather than reassurance.", 'interventionNames': ['Other: Cognitive-behavioural therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Family accommodation reduction intervention', 'description': "Cognitive-behavioural therapy intervention that guides participants' significant others to withhold reassurance when it is requested; participants are asked to refrain from seeking reassurance.", 'interventionNames': ['Other: Cognitive-behavioural therapy']}], 'interventions': [{'name': 'Cognitive-behavioural therapy', 'type': 'OTHER', 'description': 'Empirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Includes components to foster cognitive (i.e., thinking) and behavioural changes.', 'armGroupLabels': ['Family accommodation reduction intervention', 'Support-seeking intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4B 1R6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Concordia University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concordia University, Montreal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral student', 'investigatorFullName': 'Rachael Neal', 'investigatorAffiliation': 'Concordia University, Montreal'}}}}