Ignite Creation Date:
2025-12-24 @ 1:50 PM
Ignite Modification Date:
2026-01-04 @ 4:57 PM
Study NCT ID:
NCT05958095
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2023-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Curio Digital Therapy for the Treatment of Post-partum Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are not aware of whether they are receiving the MamaLift Plus interventional device or the digital placebo device. The applications have the same user interface and require a similar amount of time to complete activities. Participants in both arms will receive treatment as usual in addition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The data of 200 participants will be collected and analyzed for this study. Participants will be selected from a pool of patients who have given birth in the last three months prior to the study start date and been diagnosed with postpartum depression or have experienced depressive symptoms. The study aims to recruit a diverse study cohort across age, race, and SES to reflect the intended user population in the United States.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-07-14', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EPDS Score', 'timeFrame': '9 week period', 'description': 'Proportion of women that improve EPDS by \\>= 4 points at their end of study assessment.'}, {'measure': 'EPDS Score improvement', 'timeFrame': '9 week period', 'description': 'Proportion of women that improve EPDS to \\< 13 points at their end of study assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['PostPartum depression (PPD), symptoms of PPD, Anxiety, Peri-natal depression, mild-to-moderate depression'], 'conditions': ['PostPartum Depression']}, 'referencesModule': {'references': [{'pmid': '40549508', 'type': 'DERIVED', 'citation': 'Dixit S, Malladi I, Shankar S, Shah A. Evaluating the Efficacy of MamaLift Plus Digital Therapeutic Mobile App for Postpartum Depression (SuMMER): Randomized, Placebo-Controlled Pivotal Trial. J Med Internet Res. 2025 Jul 1;27:e69050. doi: 10.2196/69050.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective: Evaluate the clinical effectiveness of the MamaLift Plus app compared to control (digital sham plus treatment as usual) for the management of PPD in the observed population for a period of 9 calendar weeks. It is hypothesized that women who use the MamaLift Plus APP will experience less severe symptoms of depression in post-partum period than comparable women who do not and receive their usual care from health providers.', 'detailedDescription': 'Women between 18 and 50 years of age who have had a live birth within 3 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 200 women will be recruited to volunteer in the study with 166 assigned to the intervention arm and 37 assigned to the control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Adult females who delivered live births in the 3 months prior to study start', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be able to read, write and speak English; 3. Participants must provide written informed consent prior to enrollment; 4. Participants must be 18 to 50 years of age at the time of enrollment; 5. Participants must have had a live childbirth \\<=3 months prior to their enrollment into the study; 6. Participants who have a score of greater than or equal to 13 but not exceeding 19 on the Edinburgh Postnatal Depression Scale (EPDS) during initial screening visit/call; 7. Depression diagnosis needs to be confirmed by licensed behavioral health therapist or medical professional; 8. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10); 9. Participants must be willing to use a mobile app and own an iOS or android enabled mobile phone or device; 10. Participants must have wireless internet connectivity in their home (or have access to internet connectivity) and be willing to connect devices via a Wi-Fi network\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05958095', 'acronym': 'SuMMER', 'briefTitle': 'Curio Digital Therapy for the Treatment of Post-partum Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Healthcare Innovation Technology Lab'}, 'officialTitle': 'Supporting Maternal Mental Health and Emotional Regulation (SuMMER): Assessment of the Clinical Effectiveness of a Mobile Application for Patients With Postpartum Depression', 'orgStudyIdInfo': {'id': 'CU-T-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MamaLift Plus', 'description': 'Principles of Cognitive Behavioral Therapy used to treat PPD with App', 'interventionNames': ['Device: MamaLift Plus']}, {'type': 'SHAM_COMPARATOR', 'label': 'Digital Sham App', 'description': 'Content on general mental health and wellbeing topics delivered with sham App', 'interventionNames': ['Device: Digital Sham App']}], 'interventions': [{'name': 'MamaLift Plus', 'type': 'DEVICE', 'description': 'MamaLift Plus is a digital therapeutic designed to augment usual care and support the treatment of mild-to-moderate postpartum depression (PPD). This mobile-based intervention is grounded on principles of Cognitive Behavioral Therapy (CBT) and Interpersonal Therapy (IPT) and includes key content areas for the treatment management of PPD. It also includes recent developments in acceptance and commitment-based therapies, specifically for the perinatal context.', 'armGroupLabels': ['MamaLift Plus']}, {'name': 'Digital Sham App', 'type': 'DEVICE', 'description': 'The digital sham app delivers content, tips, and suggestion for general wellbeing support.', 'armGroupLabels': ['Digital Sham App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Healthcare Innovation and Technology Lab', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stan Kachnowski, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Healthcare Innovation Technology Lab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Healthcare Innovation Technology Lab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Curio Digital Therapeutics, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair', 'investigatorFullName': 'Stan Kachnowski', 'investigatorAffiliation': 'Healthcare Innovation Technology Lab'}}}}