Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-02-18 @ 3:31 AM
Study NCT ID:
NCT05591261
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-24
First Post:
2022-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strong Couples Project: Disseminating Evidence-based Relationship Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-10-19', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in relationship satisfaction', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'Couple satisfaction index'}, {'measure': 'Change in relationship instability', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '3 item Relationship Instability measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology'}, {'measure': 'Change in partner support', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '5 item Partner Support measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology'}, {'measure': 'Change in communication conflict', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '4 item communication conflict measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology'}, {'measure': 'Change in relationship confidence', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '4 item relationship confidence measure (from Stanley et al., 1994)'}, {'measure': 'Change in intervention-targeted behavior', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'PREP 3 keys and Couple Communal Identity (new measures created for this study)'}], 'secondaryOutcomes': [{'measure': 'Change in partner aggression', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '7 item partner aggression (from Doss et al., 2020, Journal of Consulting and Clinical Psychology'}, {'measure': 'Change in psychological distress', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'Kessler 6 item psychological distress'}, {'measure': 'Change in anger', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'NIH PROMIS 5 item anger measure'}, {'measure': 'Change in perceived stress', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': "Cohen's 10 item perceived stress measure"}, {'measure': 'Change in general health', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'Short Form-36 4 item general health perceptions'}, {'measure': 'Change in insomnia', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '7 item insomnia severity index'}, {'measure': 'Change in problematic alcohol use', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) 7 item problematic alcohol use'}, {'measure': 'Change in exercise', 'timeFrame': 'Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline', 'description': '1 item exercise (Behavioral Risk Factor Surveillance System 2016 adaptation)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relationships, Marital', 'Relational Problems']}, 'descriptionModule': {'briefSummary': 'The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.', 'detailedDescription': 'The objective of the research is to evaluate the effectiveness of an online intervention (ePREP) for help-seeking couples designed to promote individual and couple well-being. Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited. The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the nation in a manner that allows for scalable, sustainable program delivery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Illinois\n* Married, engaged, or living with their partner for at least 6 months\n* Both partners willing to participate in online relationship-focused programming\n\nExclusion Criteria:\n\n* One or both partners reports sever forms of intimate partner violence occurring in the relationship'}, 'identificationModule': {'nctId': 'NCT05591261', 'briefTitle': 'Strong Couples Project: Disseminating Evidence-based Relationship Education', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Urbana-Champaign'}, 'officialTitle': 'Strong Couples Project: ePREP Nationwide Dissemination', 'orgStudyIdInfo': {'id': '21550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ePREP condition', 'description': 'The ePREP program is the online version of the Prevention and Relationship Enhancement Program. It consists of 6 self-directed online sessions and accompanying homework and brief coach calls.', 'interventionNames': ['Behavioral: ePREP']}], 'interventions': [{'name': 'ePREP', 'type': 'BEHAVIORAL', 'description': '6-session online psychoeducational program with supporting coach calls', 'armGroupLabels': ['ePREP condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61820', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Allen W. Barton', 'role': 'CONTACT', 'email': 'awbarton@illinois.edu', 'phone': '217-244-2009'}], 'facility': 'University of Illinois Extension', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}