Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-28 @ 12:49 PM
Study NCT ID:
NCT00356304
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2006-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D013812', 'term': 'Therapeutics'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alejandro.interian@va.gov', 'phone': '908-647-0180', 'title': 'Alejandro Interian, Principal Investigator', 'phoneExt': '4617', 'organization': 'VA New Jersey Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Motivational Enhancement Therapy for Antidepressants', 'description': 'Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment as Usual', 'description': 'Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Medication Adherence, as Measured by Electronic Pill Container', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Enhancement Therapy for Antidepressants'}, {'id': 'OG001', 'title': 'Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '58.76', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '6.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured immediately post-treatment and at Months 2 and 5 months follow-ups', 'description': 'Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We used an ITT with LOCF. These figures represent outcomes at 5 months.'}, {'type': 'SECONDARY', 'title': 'Treatment Retention', 'timeFrame': 'Measured at Month 5', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Motivational Enhancement Therapy for Antidepressants'}, {'id': 'OG001', 'title': 'Treatment as Usual'}], 'classes': [{'categories': [{'measurements': [{'value': '16.75', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '23.03', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Month 5', 'description': 'The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.\n\n0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Medication Attitudes', 'timeFrame': 'Measured at Month 5', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Motivational Enhancement Therapy for Antidepressants', 'description': 'Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.'}, {'id': 'FG001', 'title': 'Treatment as Usual', 'description': 'Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Motivational Enhancement Therapy for Antidepressants', 'description': 'Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.'}, {'id': 'BG001', 'title': 'Treatment as Usual', 'description': 'Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '41', 'spread': '13', 'groupId': 'BG001'}, {'value': '40.6', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-10', 'studyFirstSubmitDate': '2006-07-21', 'resultsFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2006-07-21', 'lastUpdatePostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-10', 'studyFirstPostDateStruct': {'date': '2006-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Adherence, as Measured by Electronic Pill Container', 'timeFrame': 'Measured immediately post-treatment and at Months 2 and 5 months follow-ups', 'description': 'Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened. An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.'}], 'secondaryOutcomes': [{'measure': 'Treatment Retention', 'timeFrame': 'Measured at Month 5'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Measured at Month 5', 'description': 'The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3.\n\n0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.'}, {'measure': 'Medication Attitudes', 'timeFrame': 'Measured at Month 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysthymia', 'Major Depression', 'Hispanics', 'Latinos', 'Motivational Interviewing', 'Adherence'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '18048562', 'type': 'BACKGROUND', 'citation': 'Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591.'}, {'pmid': '20630257', 'type': 'BACKGROUND', 'citation': 'Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16.'}, {'pmid': '23300127', 'type': 'RESULT', 'citation': 'Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of motivational interviewing in improving antidepressant medication adherence among Hispanics.', 'detailedDescription': "Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.\n\nParticipants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-identifies as Hispanic\n* DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)\n* Currently taking antidepressant medication\n\nExclusion Criteria:\n\n* Clinically significant suicidal ideation\n* DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry\n* Unstable general medical condition'}, 'identificationModule': {'nctId': 'NCT00356304', 'briefTitle': 'Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach', 'orgStudyIdInfo': {'id': 'K23MH074860', 'link': 'https://reporter.nih.gov/quickSearch/K23MH074860', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'K23MH074860', 'link': 'https://reporter.nih.gov/quickSearch/K23MH074860', 'type': 'NIH'}, {'id': 'DSIR 8K-RT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive motivational interviewing in addition to their antidepressant therapy', 'interventionNames': ['Behavioral: Motivational interviewing']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Participants will receive treatment as usual', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'Motivational interviewing', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.', 'armGroupLabels': ['1']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Participants will continue with their normal treatment regimen as usual.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University Behavioral Healthcare', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Alejandro Interian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers, The State University of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Dentistry of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor', 'investigatorFullName': 'Alejandro Interian, Ph.D.', 'investigatorAffiliation': 'National Institute of Mental Health (NIMH)'}}}}