Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 2:43 PM
Study NCT ID:
NCT03932760
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2019-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telehealth Group Intervention for Perinatal Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Gwen.Latendresse@nurs.utah.edu', 'phone': '801-587-9636', 'title': 'Gwen Latendresse', 'organization': 'University of Utah'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations included low recruitment (largely due to COVID-19), difficulty in identifying participation in either group as the cause of lower EPDS scores 8 months after participation, and difficulty in accounting for factors impacting personal changes that can occur in the 10 months of involvement in the study.'}}, 'adverseEventsModule': {'timeFrame': 'Participant data was collected over 10 months from start of intervention.', 'description': "EPDS scores were monitored for scores over 20. While an EPDS score of \\>20 indicates a higher risk of depression and anxiety, IRB didn't considered this to be an adverse event given the target population and inclusion criteria. Participants who scored above 20 were referred to a licensed mental health professional for immediate follow-up. During sessions, facilitators also monitored participants' progress and signs they may be considering self-harm.", 'eventGroups': [{'id': 'EG000', 'title': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.\n\nUPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.\n\nAttention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 0, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Depressive Symptoms Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.\n\nUPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}, {'id': 'OG001', 'title': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.\n\nAttention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': '3.85', 'groupId': 'OG000'}, {'value': '10.52', 'spread': '4.52', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.34', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '7.69', 'spread': '3.92', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.84', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '8.90', 'spread': '5.31', 'groupId': 'OG001'}]}]}, {'title': '4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.52', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '7.10', 'spread': '4.80', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.16', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '4.49', 'groupId': 'OG001'}]}]}, {'title': '8 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.70', 'spread': '2.90', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '3.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.612', 'groupIds': ['OG001'], 'paramType': 'Mean estimates by time', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.913', 'ciLowerLimit': '-1.228', 'ciUpperLimit': '3.055', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.085', 'estimateComment': 'Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.', 'groupDescription': 'We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of EPDS between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum controlling for screening EPDS score. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.', 'otherAnalysisDescription': 'Overall test of significance for Fixed Effects. Higher EPDS scores signify worsened symptoms of depression. Time uses start of study as reference controlling for screen EPDS.\n\nGroup VCI (AC reference): F=0.260, p=0.612\n\nTime (Baseline as reference): F=9.021, p\\<0.001\n\nGroup\\*Time: F=0.537, p=0.748\n\nEstimates for group, time, and group\\*time interactions\n\nGroup:\n\nEstimate=0.913 (SE=1.085) \\[CI LB=-1.228, UB=3.055\\]\n\nTime:\n\nPost: estimate=-2.766 (0.853) \\[-4.445, -1.087\\]\n\n2 months: estimate=-1.517 (0.862) \\[-3.214, 0.180\\]\n\n4 months: estimate=-3.186 (0.862) \\[-4.883, -1.489\\]\n\n6 months: estimate=-2.781 (0.872) \\[-4.498, -1.065\\]\n\n8 months: estimate=-3.103 (0.872) \\[-4.819, -1.386\\]\n\nGroup\\*Time:\n\nPost: estimate=-1.157 (1.214) \\[-3.547, 1.232\\]\n\n2 months: estimate=-1.361 (1.210) \\[-3.742, 1.019\\]\n\n4 months: estimate= 0.183 (1.209) \\[-2.196, 2.562\\]\n\n6 months: estimate=-0.508 (1.223) \\[-2.914, 1.898\\]\n\n8 months: estimate=-0.127 (1.220) \\[-2.529, 2.275\\]'}], 'paramType': 'MEAN', 'timeFrame': 'Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention', 'description': 'Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores \\< 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; \\> 20 = severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed differs from Overall Number of Participants Analyzed due to participants becoming ineligible, withdrawing, and opting to not complete surveys at certain time points.'}, {'type': 'SECONDARY', 'title': 'Change in Anxiety Symptoms Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.\n\nUPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}, {'id': 'OG001', 'title': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.\n\nAttention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.97', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '6.97', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.17', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '5.17', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': '2 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.31', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '6.31', 'spread': '4.04', 'groupId': 'OG001'}]}]}, {'title': '4 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.45', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.74', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '4.18', 'groupId': 'OG001'}]}]}, {'title': '8 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.35', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '2.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.558', 'groupIds': ['OG001'], 'paramType': 'Mean estimates by time', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0160', 'ciLowerLimit': '-1.709', 'ciUpperLimit': '1.677', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.859', 'estimateComment': 'Time was treated as a categorical variable to allow for non-linear change over time. We present group, time, and group\\*time estimates and their associated SE and CIs below. AC group and baseline timepoint are the reference categories.', 'groupDescription': 'We used multilevel generalized mixed modeling under an intent-to-treat approach to compare the outcome measures of GAD-7 between group 1 (VCI) and Group 2 (AC) at 6 time points during pregnancy and postpartum. We powered for the fixed effect of Intervention X Time using RMANOVA with alpha = 0.5, 6 time points, 0.3 for correlation between repeated measures, and a sample size of 192 total participants gives greater than 90% power to detect an effect size of 0.1.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Mean differences at the tested timepoints between VCI and AC. Models were also examined with the covariates of medication use and pregnant/post-partum status.', 'otherAnalysisDescription': 'Overall test of significance for Fixed Effects. Higher GAD-7 scores signify worsened symptoms of depression.\n\nGroup VCI (AC reference): F=0.347, p=0.558\n\nTime (Baseline as reference): F=4.973, p\\<0.001\n\nGroup\\*Time: F=0.417, p=0.837\n\nEstimates for group, time, and group\\*time interactions\n\nGroup:\n\nEstimate=-0.0160 (SE=0.859) \\[CI LB=-1.709, UB=1.677\\]\n\nTime:\n\nPost: estimate=-1.780 (0.708) \\[-3.173, -0.387\\]\n\n2 months: estimate=-0.615 (0.715) \\[-2.023, 0.792\\]\n\n4 months: estimate=-1.416 (0.715) \\[-2.824, -0.008\\]\n\n6 months: estimate=-1.625 (0.723) \\[-3.049, -0.201\\]\n\n8 months: estimate=-1.542 (0.723) \\[-2.966, -0.118\\]\n\nGroup\\*Time:\n\nPost: estimate=-1.157 (1.214) \\[-3.547, 1.232\\]\n\n2 months: estimate=-1.361 (1.210) \\[-3.742, 1.019\\]\n\n4 months: estimate= 0.183 (1.209) \\[-2.196, 2.562\\]\n\n6 months: estimate=-0.508 (1.223) \\[-2.914, 1.898\\]\n\n8 months: estimate=-0.127 (1.220) \\[-2.529, 2.275\\]'}], 'paramType': 'MEAN', 'timeFrame': 'Time 1 = pre-intervention; T2 = immediately following week 9 of group intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention', 'description': 'Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of \\< 5 = no anxiety; 5-9 = mild; 10-14 = moderate; \\> 15 = severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number Analyzed differs from Overall Number of Participants Analyzed due to participants becoming ineligible, withdrawing, and opting to not complete surveys at certain time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.\n\nUPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}, {'id': 'FG001', 'title': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.\n\nAttention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Baseline', 'comment': 'Number of participants who completed survey at baseline.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Post', 'comment': 'Number of participants who completed survey post intervention.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': '2 Months', 'comment': 'Number of participants who completed survey at 2 months.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': '4 Months', 'comment': 'Number of participants who completed survey at 4 months.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': '6 Months', 'comment': 'Number of participants who completed survey at 6 months.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': '8 Months', 'comment': 'Number of participants who completed survey at 8 months.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Became Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'During the period from May 1, 2020 through May 31, 2022, 535 women were reached out to for participation in the study. Participants were recruited from University of Utah UHealth clinics as well as rural health districts.', 'preAssignmentDetails': 'Out of the 535 women reached out to, 331 were unable to be contacted after four attempts. Of the remaining 204, 58 were ineligible for a combination of non-mutually exclusive factors including mental health diagnoses (n= 35), medication changes in the last 6 weeks (n=15), \\>6 months postpartum (n=9), and other (n=6). Of the 147 who remained eligible to participate, 99 were consented. Of these, 17 were lost to contact prior to randomization, and 81participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.\n\nUPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}, {'id': 'BG001', 'title': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.\n\nAttention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '41'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '39'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-17', 'size': 340947, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-20T14:32', 'hasProtocol': True}, {'date': '2021-09-22', 'size': 269628, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-10-20T15:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2019-04-16', 'resultsFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2019-04-26', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-06', 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive Symptoms Over Time', 'timeFrame': 'Time 1 = pre-intervention (Baseline); T2 = immediately following week 9 of group intervention classes (Post), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention', 'description': 'Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores \\< 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; \\> 20 = severe.'}], 'secondaryOutcomes': [{'measure': 'Change in Anxiety Symptoms Over Time', 'timeFrame': 'Time 1 = pre-intervention; T2 = immediately following week 9 of group intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention', 'description': 'Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of \\< 5 = no anxiety; 5-9 = mild; 10-14 = moderate; \\> 15 = severe.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perinatal Depression']}, 'referencesModule': {'references': [{'pmid': '39542133', 'type': 'DERIVED', 'citation': 'Iacob E, Kausler R, Williams M, Simonsen S, Smid M, Weissinger K, Latendresse G. Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms. Contemp Clin Trials. 2024 Dec;147:107738. doi: 10.1016/j.cct.2024.107738. Epub 2024 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the project is to evaluate for the first time, the effectiveness of using a telehealth approach to reducing perinatal depressive symptoms in diverse groups of childbearing women; urban and rural-dwelling, and from Hispanic and predominantly North European Descent populations. Pregnant women connect for one hour weekly, for 8 weeks, using their own electronic device, from whatever location they choose (e.g. home), to attend videoconference groups facilitated by a mental health professional. The approach is cost effective and reduces barriers to access to mental health services, particularly for women living in rural, low-resource, and minority communities, and those without adequate transportation, financial resources, childcare, or work release time.', 'detailedDescription': "Perinatal depression (PD) affects 12-15% of women and contributes to adverse outcomes, e.g. preterm birth, low birth weight, and impaired cognitive development of the child. Screening optimizes the detection of PD, but does not reduce barriers to mental health services (MHS) encountered by women who screen positive. A known shortage of MHS across the nation is a significant barrier, particularly in low resource and rural settings. Telehealth is a promising approach to reducing barriers, but there is little research on the effectiveness of telehealth to reduce perinatal depressive symptoms (PDS). There is high potential for telehealth to deliver effective, lower cost MHS to childbearing women, particularly those in low resource settings.\n\nThe proposed project is a randomized controlled trial among women with mild to moderate PDS. The project aims to evaluate; 1) the effectiveness of a group mental health videoconference intervention (VCI) to reduce PDS across pregnancy and postpartum, and (2) differences in PDS between diverse groups of childbearing women: rural and urban-dwelling, and Latina and predominantly North European Descent (NED) populations. The investigators hypothesize that women participating in the VCI will have significantly lower PDS across pregnancy and postpartum than women in an equivalent attention control (AC) group, and the results will differ between diverse groups. A total of 192 women will be enrolled; 48 in each study group. Participants are randomly assigned to study groups: VCI +standard of care, or AC + standard of care. Sessions are delivered via Utah Telehealth Network (UTN). Women in both groups attend weekly one-hour group sessions for 8 weeks using any electronic device (laptop, tablet, smart phone) from their own home. PDS is measured six times throughout enrollment--Time 1 = pre-intervention; T2 = immediately following week 9 of group intervention classes (post-intervention), T3= 2 months post-intervention; T4= 4 months post-intervention; T5 = 6 months post-intervention; T6 = 8 post-intervention.\n\nThis study is the first to use a VCI to engage women in a facilitated group approach to reducing PDS, and to evaluate the impact among diverse groups. The approach is cost effective and reduces barriers to access to MHS, particularly for women living in low-resource, and minority communities, and those without adequate transportation, childcare, or work release time. The VCI can be replicated in any setting (e.g. rural or urban), and can be adapted to the needs of diverse communities. The study advances the field by establishing whether a group telehealth intervention reduces PDS, and whether this differs based on the population. If effective and implemented broadly, far fewer women and families would suffer the negative consequences of depression. The project is in line with NINR's high priority areas, including the use of technology to promote health, and a focus on self-management and symptom science."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant and postpartum women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women age 18 and older\n* have a viable pregnancy (any gestational age) or postpartum (up to 6 months)\n* have an Edinburgh Postpartum Depression Scale (EPDS) score between 9 and 20\n* are English or Spanish speaking\n* are receiving clinical services at a collaborating prenatal or public health clinic associated with the U of Utah or Utah rural Health Districts\n\nExclusion Criteria:\n\n* women who have an EPDS score less than 9 or greater than 20\n* have a current diagnosis of a serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression, suicidal ideation, homicidal ideation\n* begun taking or changed dosage of any medications for a mental health condition within the previous 6 weeks'}, 'identificationModule': {'nctId': 'NCT03932760', 'acronym': 'TePOP', 'briefTitle': 'Telehealth Group Intervention for Perinatal Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations', 'orgStudyIdInfo': {'id': 'IRB_00113917'}, 'secondaryIdInfos': [{'id': 'R01NR017620', 'link': 'https://reporter.nih.gov/quickSearch/R01NR017620', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UPLIFT Program', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.', 'interventionNames': ['Behavioral: UPLIFT Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pregnancy Skills Group', 'description': 'Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.', 'interventionNames': ['Behavioral: Attention Control Group']}], 'interventions': [{'name': 'UPLIFT Program', 'type': 'BEHAVIORAL', 'description': 'UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.', 'armGroupLabels': ['UPLIFT Program']}, {'name': 'Attention Control Group', 'type': 'BEHAVIORAL', 'description': 'Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.', 'armGroupLabels': ['Pregnancy Skills Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Gwen Latendresse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The PI agrees to make available data within one year of the completion of the funded project period', 'ipdSharing': 'YES', 'description': 'The PI will share de-identified data to other investigators for study, including demographics, outcomes, communication methodology, and design. Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes. The PI agrees to make available data within one year of the completion of the funded project period and manuscripts pertaining to the aims. The PI agrees to share data in a manner that is fully consistent with NIH data sharing policies and applicable laws and regulations.', 'accessCriteria': 'Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and can be used for secondary study purposes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assitant Dean, Associate Professor', 'investigatorFullName': 'Gwen Latendresse', 'investigatorAffiliation': 'University of Utah'}}}}