Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-10 @ 8:47 AM
Study NCT ID:
NCT05551195
Status:
TERMINATED
Last Update Posted:
2025-02-24
First Post:
2022-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kate@woebothealth.com', 'phone': '(415) 209-5642', 'title': 'Kate Martin', 'organization': 'Woebot Health'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'description': 'Systematic assessment of adverse events included Principal Investigator assessment as well as unsolicited participant reports.', 'eventGroups': [{'id': 'EG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Rating Scale for Depression (HAM-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '3.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant missing data at Week 8'}, {'type': 'SECONDARY', 'title': 'Edinburgh Postpartum Depression Scale (EPDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '-6.83', 'spread': '6.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': 'Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'spread': '0', 'groupId': 'OG000'}, {'value': '-8.17', 'spread': '6.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': 'Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Generalized Anxiety Disorder Questionnaire (GAD-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '-6.33', 'spread': '2.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mother-to-Infant Bonding Scale (MIBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '0', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions Scale - Severity of Illness (CGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': "Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions Scale - Global Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Mid-treatment at Week 4 to Post-treatment at Week 8', 'description': "Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression Scale (PGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'title': 'PGI-S', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'PGI-C', 'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8', 'description': 'Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). PGI-S responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Client Satisfaction Questionnaire (CSQ-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'OG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '0', 'groupId': 'OG000'}, {'value': '29', 'spread': '4.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-treatment at Week 8', 'description': "An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not complete the CSQ-8'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'FG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'WB001 With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.\n\nWB001: WB001 is a digital therapeutic for postpartum depression.'}, {'id': 'BG001', 'title': 'Educational Control (ED001) With Adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.\n\nED001: ED001 is a digital therapeutic for postpartum depression.'}, {'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': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', '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': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'title': 'New York (Northeast)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Florida (Southeast)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'California (West)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-03', 'size': 936590, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-22T12:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Internal company decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-09-19', 'resultsFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-21', 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HAM-D)', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.'}], 'secondaryOutcomes': [{'measure': 'Edinburgh Postpartum Depression Scale (EPDS)', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': 'Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression.'}, {'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': 'Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression'}, {'measure': 'Generalized Anxiety Disorder Questionnaire (GAD-7)', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety.'}, {'measure': 'Mother-to-Infant Bonding Scale (MIBS)', 'timeFrame': 'Change from Baseline to Post-treatment at Week 8', 'description': 'Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding.'}, {'measure': 'Clinical Global Impressions Scale - Severity of Illness (CGI-S)', 'timeFrame': 'Change Baseline to Post-treatment at Week 8', 'description': "Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill)."}, {'measure': 'Clinical Global Impressions Scale - Global Improvement (CGI-I)', 'timeFrame': 'Change from Mid-treatment at Week 4 to Post-treatment at Week 8', 'description': "Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse)."}, {'measure': 'Patient Global Impression Scale (PGI)', 'timeFrame': 'PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8', 'description': 'Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). PGI-S responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Post-treatment at Week 8', 'description': "An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Postpartum Depression', 'PPD', 'Postpartum Depression Treatment', 'PPD Treatment', 'Smartphone application', 'Digital therapeutic'], 'conditions': ['Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.', 'detailedDescription': 'This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have primary residence in the United States\n2. Must be ≤ 92 days postpartum\n3. Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery\n4. Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study\n5. Participants must have current mild-moderate depression as measured by the HAMD-6 score \\>7 and \\<13 at screening\n6. Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof\n7. TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit\n\nExclusion Criteria:\n\n1. Gestation less than 28 weeks\n2. HAMD-6 score ≤7 or ≥13 (severe depression) at screening\n3. Currently pregnant or plans to become pregnant within the next 8 weeks\n4. History of drug and/or alcohol use disorder within the past 12 months\n5. Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD\n6. Current or lifetime psychosis\n7. Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation\n8. History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device\n9. History of treatment-resistant depression (TRD)\n10. Fetal demise within the past 18 months'}, 'identificationModule': {'nctId': 'NCT05551195', 'briefTitle': '[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Woebot Health'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression', 'orgStudyIdInfo': {'id': 'WB001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'WB001 with adjunctive Treatment as Usual', 'description': 'Participants randomized to the WB001 + TAU group will be asked to download and use the study application.', 'interventionNames': ['Device: WB001']}, {'type': 'OTHER', 'label': 'Educational Control (ED001) with adjunctive Treatment as Usual', 'description': 'Participants randomized to the ED001 + TAU group will be asked to download and use the study application.', 'interventionNames': ['Device: ED001']}], 'interventions': [{'name': 'WB001', 'type': 'DEVICE', 'description': 'WB001 is a digital therapeutic for postpartum depression.', 'armGroupLabels': ['WB001 with adjunctive Treatment as Usual']}, {'name': 'ED001', 'type': 'DEVICE', 'description': 'ED001 is a digital therapeutic for postpartum depression.', 'armGroupLabels': ['Educational Control (ED001) with adjunctive Treatment as Usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94549', 'city': 'Lafayette', 'state': 'California', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 37.88576, 'lon': -122.11802}}, {'zip': '92704', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33016', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33777', 'city': 'Seminole', 'state': 'Florida', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 27.83975, 'lon': -82.79121}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '11004', 'city': 'Glen Oaks', 'state': 'New York', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 40.74705, 'lon': -73.71152}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Woebot Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Woebot Health', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Iqvia Pty Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}