Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT00292903
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2006-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression
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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-06', 'studyFirstSubmitDate': '2006-02-15', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'Measured throughout treatment and at Months 2 and 6 postpartum'}, {'measure': 'Treatment attendance', 'timeFrame': 'Measured at Week 12'}]}, 'conditionsModule': {'keywords': ['Perinatal Depression', 'Interpersonal Psychotherapy'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '37146219', 'type': 'DERIVED', 'citation': 'Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the effectiveness of brief interpersonal psychotherapy versus standard treatment for pregnant women with depression.', 'detailedDescription': "Depression is a serious condition affecting millions of people each year. In fact, it is estimated that approximately one in every four women will be treated for a mood disorder, such as depression, at some point in her life. As effective treatment options continue to develop, many women diagnosed with depression are able to resume normal lives and may choose to become pregnant. Also, some women become depressed when pregnant. Interpersonal psychotherapy involves treating psychological difficulties by analyzing problems, talking about possible solutions, and learning more helpful ways of thinking and acting. Brief interpersonal psychotherapy (IPT-B) is a well-tested psychotherapy for depression that has been shortened and modified. The purpose of this study is to evaluate the effectiveness of IPT-B to reduce depressive symptoms in women during pregnancy and to prevent the continuation or recurrence of their depression postpartum.\n\nParticipants in this open-label study will be randomly assigned to receive either IPT-B or a facilitated referral for treatment as usual (F-TAU) at an outpatient clinic or community mental health center. Participants assigned to IPT-B will be scheduled to attend eight treatment sessions along with their prenatal clinic visits within a 16-week period. Each treatment session will begin with a brief 1-minute evaluation to assess participants' level of depression and will end with a brief evaluation of the session. Participants will attend follow-up sessions every 2 weeks until 3 months postpartum and then monthly until 6 months postpartum. These sessions will include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment. Participants assigned to receive F-TAU will be provided with verbal and written information regarding their depressive symptoms. They will also receive a referral for treatment at a behavioral health clinic. Participants receiving F-TAU will be assessed via telephone at Weeks 6 and 12. All participants will be assessed via telephone at Months 2 and 6 postpartum to measure their level of depression."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 8 and 32 weeks of gestation at time of study entry\n* A score above 12 on the Edinburgh Postnatal Depression Scale\n* Speaks English\n* Resides in the Pittsburgh, PA, area\n* Access to a household telephone\n\nExclusion Criteria:\n\n* Currently receiving treatment for depression (i.e., medication or psychotherapy)\n* History of a prior manic episode\n* Alcohol or drug abuse or dependence within 6 months of study entry\n* Psychotic disorder or organic mental disorder\n* Suicidal, homicidal, or requires hospitalization\n* Severe sexual and/or physical aggression in relationship with partner or husband\n* Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease\n* Severe cognitive deficits that would prevent treatment with psychotherapy'}, 'identificationModule': {'nctId': 'NCT00292903', 'briefTitle': 'Evaluating the Effectiveness of Brief Interpersonal Psychotherapy for Pregnant Women With Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Culturally Relevant Brief Interpersonal Psychotherapy (IPT-B) for Perinatal Depression', 'orgStudyIdInfo': {'id': 'MH30915'}, 'secondaryIdInfos': [{'id': '5R01MH084897-03', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH084897-03', 'type': 'NIH'}, {'id': 'DSIR 83-ATSO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Behavioral: Brief interpersonal psychotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Behavioral: Facilitated referral for treatment as usual']}], 'interventions': [{'name': 'Brief interpersonal psychotherapy', 'type': 'BEHAVIORAL', 'description': "IPT-B sessions include evaluation of participants' level of depression, identification of any difficulties or problems that participants may be experiencing, and review of how to manage these problems using skills learned during treatment.", 'armGroupLabels': ['A']}, {'name': 'Facilitated referral for treatment as usual', 'type': 'BEHAVIORAL', 'description': 'F-TAU includes providing verbal and written information regarding depressive symptoms and a referral for treatment at a behavioral health clinic.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee Womens Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Nancy K. Grote, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh, School of Social Work'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Nancy K. Grote, PhD', 'oldOrganization': 'University of Pittsburgh'}}}}