{"protocolSection":{"identificationModule":{"nctId":"NCT04094870","orgStudyIdInfo":{"id":"17-3411"},"secondaryIdInfos":[{"id":"1R21MH115806","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R21MH115806"},{"id":"Z 31801","type":"OTHER","domain":"UNC"}],"organization":{"fullName":"University of North Carolina, Chapel Hill","class":"OTHER"},"briefTitle":"A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women","officialTitle":"Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women"},"statusModule":{"statusVerifiedDate":"2020-12","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-10-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-10-30","type":"ACTUAL"},"completionDateStruct":{"date":"2020-10-30","type":"ACTUAL"},"studyFirstSubmitDate":"2019-09-16","studyFirstSubmitQcDate":"2019-09-16","studyFirstPostDateStruct":{"date":"2019-09-19","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-09-01","resultsFirstSubmitQcDate":"2021-10-12","resultsFirstPostDateStruct":{"date":"2021-11-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-10-12","lastUpdatePostDateStruct":{"date":"2021-11-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of North Carolina, Chapel Hill","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":true},"descriptionModule":{"briefSummary":"This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.","detailedDescription":"The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks."},"conditionsModule":{"conditions":["Perinatal Depression","HIV-1-infection"],"keywords":["perinatal depression","HIV","Antiretroviral Treatment","Interpersonal psychotherapy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":80,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Antidepressant medication","type":"ACTIVE_COMPARATOR","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table","interventionNames":["Drug: Sertraline"]},{"label":"Interpersonal therapy","type":"ACTIVE_COMPARATOR","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization","interventionNames":["Behavioral: Interpersonal therapy"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"daily SSRI (Sertraline 25mg)","armGroupLabels":["Antidepressant medication"],"otherNames":["SSRI"]},{"type":"BEHAVIORAL","name":"Interpersonal therapy","description":"11 sessions over a 24-week period","armGroupLabels":["Interpersonal therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Women Approached Who Agreed to Pre-Screening With EPDS","description":"In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum","timeFrame":"2-7 weeks postpartum"},{"measure":"Number of Women Pre-Screened Who Have an EPDS Score >/= 6","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \\>/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS \\>/= 6 out of all of the women who were pre-screened with an EPDS.","timeFrame":"2-7 weeks postpartum"},{"measure":"Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI","description":"MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS \\>/=6 were invited to undergo MINI diagnostic testing after signed consent.","timeFrame":"2-7 weeks postpartum"},{"measure":"Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study","description":"MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.","timeFrame":"6-8 weeks postpartum"},{"measure":"Number of Women Retained in the Study","description":"Number of women who are enrolled in the study who complete the final study visit","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"}],"secondaryOutcomes":[{"measure":"Number of Women With an EPDS Score Decline of 3 Points From Baseline","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \\> 6 is indicative of a woman being at risk of perinatal depression.","timeFrame":"Enrollment - final study visit, approximately 24 weeks after enrollment"},{"measure":"Number of Women With a CGI Score Decline of One Point From Baseline","description":"The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with the patient. Lower scores correlate with clinical improvement.","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"},{"measure":"Percentage of Women Experiencing Anti Depressant Medication Toxicity","description":"The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"},{"measure":"Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)","description":"Percentage of women randomized to the ADM arm with adequate adherence defined as taking \\>90% of pills assessed by pill count and report","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"},{"measure":"Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)","description":"Number of women randomized to the IPT arm who complete all IPT sessions","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"},{"measure":"Acceptability of Trial Participation for Treatment of Postpartum Depression","description":"Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: \"Strongly disagree\", \"disagree\", \"neutral\", \"agree\", and \"strongly agree\". For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral.","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"},{"measure":"Changes in the Viral Load Between Study Entry and the Last Visit","description":"The mean change in the viral load will be measured between all women enrolled between the first and last visits","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n* 18 years of age or older\n* Documentation of confirmed HIV-1 infection\n* Six to eight weeks postpartum\n* Currently taking ART treatment\n* Able and willing to provide written informed consent\n* Willing to adhere to study visit schedule\n* PND diagnosis confirmed by Mini-International Neuropsychiatric Interview\n\nExclusion criteria:\n\n* Taking an ADM in the prior 12 months prior to enrollment\n* Actively suicidal\n* Known or suspected allergy or contraindication to first line Sertraline\n* Any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Elizabeth Stringer, MD","affiliation":"University of North Carolina, Chapel Hill","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Kamwala District Health Centre","city":"Lusaka","country":"Zambia","geoPoint":{"lat":-15.40669,"lon":28.28713}},{"facility":"University Teaching Hospital","city":"Lusaka","country":"Zambia","geoPoint":{"lat":-15.40669,"lon":28.28713}}]},"referencesModule":{"references":[{"pmid":"35803896","type":"DERIVED","citation":"Spelke MB, Paul R, Blette BS, Meltzer-Brody S, Schiller CE, Ncheka JM, Kasaro MP, Price JT, Stringer JSA, Stringer EM. Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial. J Int AIDS Soc. 2022 Jul;25(7):e25959. doi: 10.1002/jia2.25959."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.","timeFrame":"9 to 36 months following publication","accessCriteria":"Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Antidepressant Medication","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table\n\nSertraline: daily SSRI (Sertraline 25mg)"},{"id":"FG001","title":"Interpersonal Therapy","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization\n\nInterpersonal therapy: 11 sessions over a 24-week period"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"40"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"39"},{"groupId":"FG001","numSubjects":"39"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Antidepressant Medication","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table\n\nSertraline: daily SSRI (Sertraline 25mg)"},{"id":"BG001","title":"Interpersonal Therapy","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization\n\nInterpersonal therapy: 11 sessions over a 24-week period"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"80"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.5","spread":"5.5"},{"groupId":"BG001","value":"30.0","spread":"5.3"},{"groupId":"BG002","value":"29.7","spread":"5.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"80"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"80"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"80"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Zambia","categories":[{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"80"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Women Approached Who Agreed to Pre-Screening With EPDS","description":"In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"2-7 weeks postpartum","groups":[{"id":"OG000","title":"Approached Patients","description":"Eligible patients approached for participation"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"240"}]}]}]},{"type":"PRIMARY","title":"Number of Women Pre-Screened Who Have an EPDS Score >/= 6","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \\>/= 6 is indicative of a woman being at risk of perinatal depression. The number of women with an EPDS \\>/= 6 out of all of the women who were pre-screened with an EPDS.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"2-7 weeks postpartum","groups":[{"id":"OG000","title":"Approached Patients Who Completed Pre-Screening EPDS","description":"Potentially eligible patients who underwent pre-screening with EPDS"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"199"}]}]}]},{"type":"PRIMARY","title":"Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI","description":"MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment. After pre screening with an EPDS, women with an EPDS \\>/=6 were invited to undergo MINI diagnostic testing after signed consent.","populationDescription":"199 women were eligible for the MINI based on an EPDS \\>/= 6.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"2-7 weeks postpartum","groups":[{"id":"OG000","title":"All Participants With an EPDS >/=6","description":"Women eligible for the MINI based on an EPDS \\>/=6"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"199"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"120"}]}]}]},{"type":"PRIMARY","title":"Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study","description":"MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. MINI modules were used: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.","populationDescription":"91 met diagnostic criteria by MINI.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6-8 weeks postpartum","groups":[{"id":"OG000","title":"Women Who Met Diagnostic Criteria by MINI and Agreed to Participate in the Study","description":"Eligible women diagnosed with anxiety or depression based on the MINI who agree to participate"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"91"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"80"}]}]}]},{"type":"PRIMARY","title":"Number of Women Retained in the Study","description":"Number of women who are enrolled in the study who complete the final study visit","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"Antidepressant Medication","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table\n\nSertraline: daily SSRI (Sertraline 25mg)"},{"id":"OG001","title":"Interpersonal Therapy","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization\n\nInterpersonal therapy: 11 sessions over a 24-week period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"39"}]}]}]},{"type":"SECONDARY","title":"Number of Women With an EPDS Score Decline of 3 Points From Baseline","description":"The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of \\> 6 is indicative of a woman being at risk of perinatal depression.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Enrollment - final study visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"Antidepressant Medication","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table\n\nSertraline: daily SSRI (Sertraline 25mg)"},{"id":"OG001","title":"Interpersonal Therapy","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization\n\nInterpersonal therapy: 11 sessions over a 24-week period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"39"}]}]}]},{"type":"SECONDARY","title":"Number of Women With a CGI Score Decline of One Point From Baseline","description":"The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with the patient. Lower scores correlate with clinical improvement.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"Antidepressant Medication","description":"Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table\n\nSertraline: daily SSRI (Sertraline 25mg)"},{"id":"OG001","title":"Interpersonal Therapy","description":"Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization\n\nInterpersonal therapy: 11 sessions over a 24-week period"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"39"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"39"}]}]}]},{"type":"SECONDARY","title":"Percentage of Women Experiencing Anti Depressant Medication Toxicity","description":"The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of women who discontinued","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"Women Assigned to the Antidepressant Medication Arm","description":"All women who were randomized to the medication arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)","description":"Percentage of women randomized to the ADM arm with adequate adherence defined as taking \\>90% of pills assessed by pill count and report","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"All Women Assigned to the Antidepressant Medication Arm","description":"All women who were randomized to the medication arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}]}]},{"type":"SECONDARY","title":"Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)","description":"Number of women randomized to the IPT arm who complete all IPT sessions","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Enrollment - final visit, approximately 24 weeks after enrollment","groups":[{"id":"OG000","title":"All Women Assigned to the Therapy Arm","description":"Women who were randomized to the interpersonal therapy arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"40"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}]}]},{"type":"SECONDARY","title":"Acceptability of Trial Participation for Treatment of Postpartum Depression","description":"Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. 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