Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-28 @ 1:33 PM
Study NCT ID:
NCT01410669
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2011-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing Intervention for Intimate Partner Violence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-03', 'studyFirstSubmitDate': '2011-08-01', 'studyFirstSubmitQcDate': '2011-08-03', 'lastUpdatePostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-efficacy', 'timeFrame': 'Change from Baseline in Self efficacy at 6 months', 'description': 'The Domestic Violence Coping Self-efficacy Measure by Benight et al (2004) was modified to measure self efficacy at baseline and 6-months post randomization'}], 'secondaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Change from Baseline in depression at 6 months', 'description': 'Depression at baseline and 6-month follow-up was measured using the 10 item Center for Epidemiologic Studies Depression Scale (CES-D )'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Self-efficacy', 'Intimate partner violence', 'Randomized clinical trial', 'Depression'], 'conditions': ['Self-efficacy']}, 'referencesModule': {'references': [{'pmid': '32608505', 'type': 'DERIVED', 'citation': "Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2."}]}, 'descriptionModule': {'briefSummary': 'This project is a randomized trial to determine if motivational interviewing (MI) is an effective intervention to help women in abusive intimate relationships. The study objective is to motivate abused women to identify and achieve their own specific goals that can help them address the violence in their lives. This project will be integrated into the setting of a busy family planning clinic in the mid-western United States, which serves a largely rural population. Intimate partner violence (IPV) is screened using the Women\'s Experience with Battering Scale (WEB), a modified Abuse Assessment Screen (AAS), and the Danger Assessment Screen (DAS). An expected 250 women who screen positive for IPV will be enrolled, randomized to the intervention or to usual care group, and complete the 6-month study protocol. All subjects complete a self-administered computer-based questionnaire at the initial and 6-month follow up visits to measure self-efficacy (primary outcome), stage of readiness to change, selected IPV-related health correlates (e.g., depression), and steps taken and resources used. The MI intervention is an "active listening" counseling technique aimed at guiding the patient towards identifying feasible, personalized goals and steps she can take to increase her self-efficacy and control in the relationship. The trained study interviewer will work with participants to identify steps they can safely take and local resources to help them meet their goals. The MI protocol consists of a face-to-face counseling session at baseline with follow-up telephone interviews conducted at 1-, 2-, and 4-months post-intervention to reinforce the intervention and assess the participants\' level safety. The control group will receive usual care, which includes talking with a Level 3 Domestic Violence Advocate and receiving a comprehensive list of domestic violence resources. Effectiveness of the MI intervention will be determined by increased self-efficacy, measured by the Domestic Violence Coping and Self-Efficacy Scale, a validated tool for use among women with a recent history of domestic abuse; and by a reduction in depressive symptoms (CESD-10). The impact of the intervention will be assessed by an increase in participants\' readiness-to-change, and extent of their involvement in a wide variety of self-help and coping activities over the follow-up period. If successful, this screening and intervention program will be translated to other clinical settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Screens positive for IPV\n* Literate in either English or Spanish\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* pregnant at time of screening and consent'}, 'identificationModule': {'nctId': 'NCT01410669', 'acronym': 'ISIS', 'briefTitle': 'Motivational Interviewing Intervention for Intimate Partner Violence', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Is Motivational Interviewing an Effective Intervention for Women Coping With Intimate Partner Violence', 'orgStudyIdInfo': {'id': '5R49CE000924-03', 'link': 'https://reporter.nih.gov/quickSearch/5R49CE000924-03', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motivational Interviewing (MI)', 'interventionNames': ['Behavioral: Motivational interviewing (MI)']}], 'interventions': [{'name': 'Motivational interviewing (MI)', 'type': 'BEHAVIORAL', 'description': 'MI is a "client-centered" counseling approach developed to deliver stage-tailored intervention messages using non-confrontational, supportive communication strategies. The client is encouraged to explore the barriers and facilitating factors associated with the behavior change. The interviewer\'s role is to guide the conversation and avoid use of conventional directive approaches (e.g., persuasion, providing information).\n\nIn this trial, a trained motivational interviewer meets individually with patients randomized to the intervention for one-hour at baseline, followed by four MI telephone follow up contacts at 1-, 2-, and 4-months post baseline.', 'armGroupLabels': ['Motivational Interviewing (MI)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Audrey F Saftlas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}, {'name': 'Corinne Peek-Asa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Audrey F. Saftlas, MPH PhD', 'oldOrganization': 'University of Iowa'}}}}