Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05596318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2022-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perinatal Research on Improving Sleep and Mental Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-02', 'size': 932542, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-21T16:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2022-10-24', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of perinatal depression, as assessed by the Structured Clinical Interview for the DSM-5 (SCID)', 'timeFrame': 'Baseline to 12 months postpartum', 'description': 'This is a binary outcome that measures whether a participant experienced a depressive episode at any point since randomization.'}], 'secondaryOutcomes': [{'measure': 'Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': 'Baseline to 12 months postpartum', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.'}, {'measure': 'Change in depressive symptom severity from baseline to 12 months postpartum, as assessed by the Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline to 12 months postpartum', 'description': 'The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.'}, {'measure': 'Change in suicidal ideation severity, as rated by the C-SSRS', 'timeFrame': 'Baseline to 12 months postpartum', 'description': 'The Columbia Suicide Severity Rating Scale suicidal ideation score ranges from 1-5, with greater scores indicating more severe ideation, based on the following categories:\n\n1. \\- Wish to be Dead\n2. \\- Non-specific Active Suicidal Thoughts\n3. \\- Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act\n4. \\- Active Suicidal Ideation with Some Intent to Act, without Specific Plan\n5. \\- Active Suicidal Ideation with Specific Plan and Intent'}, {'measure': 'Change in anxiety symptom severity, as assessed by the GAD-7', 'timeFrame': 'Baseline to 12 months postpartum', 'description': 'The Generalized Anxiety Disorder-7 score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.'}, {'measure': 'Change in prenatal insomnia symptom severity as a mediator of the effect of digital CBT-I on perinatal depression, as assessed by the ISI', 'timeFrame': 'Baseline to 10 weeks post-randomization (mediator)', 'description': 'The Insomnia Severity Index (ISI) score ranges from 0 to 28, with higher scores indicating greater insomnia severity.'}, {'measure': 'Baseline depressive symptom severity as a moderator, as assessed by the EPDS', 'timeFrame': 'Baseline', 'description': 'The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30, with higher scores indicating greater depressive symptom severity.'}, {'measure': 'Baseline depressive symptom severity as a moderator, as assessed by the PHQ-9', 'timeFrame': 'Baseline', 'description': 'The Patient Health Questionnaire-9 (PHQ-9) score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Insomnia', 'Depression']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are:\n\n1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression?\n2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement?\n3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity?\n\nParticipants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant 14-28 weeks gestation\n* 18 years or older\n* Daily access to a web-enabled computer, smart phone, or tablet\n* Current elevated insomnia symptom severity and insomnia disorder\n* English speaking\n\nExclusion Criteria:\n\n* Current major depression\n* Taking or planning to take antidepressant medication (ADM)\n* Other diagnosed or suspected sleep disorder\n* Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest)\n* Night shift worker'}, 'identificationModule': {'nctId': 'NCT05596318', 'acronym': 'PRISM', 'briefTitle': 'Perinatal Research on Improving Sleep and Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression', 'orgStudyIdInfo': {'id': '21-35440'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital cognitive behavior therapy for insomnia (CBT-I)', 'interventionNames': ['Device: Digital CBT-I']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital sleep hygiene education (SHE)', 'interventionNames': ['Device: Digital SHE']}], 'interventions': [{'name': 'Digital CBT-I', 'type': 'DEVICE', 'otherNames': ['Sleepio'], 'description': 'The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia.', 'armGroupLabels': ['Digital cognitive behavior therapy for insomnia (CBT-I)']}, {'name': 'Digital SHE', 'type': 'DEVICE', 'description': 'The digital SHE program was created by Big Health, Ltd and has a total of six sessions. The content for SHE includes education about sleep stages, sleep architecture, sleep cycles; education about importance of sleep for performance, mood, and health; recommendations for developing healthy sleep habits; recommendations for lifestyle factors that impact sleep; recommendations for creating a sleep-friendly bedroom.', 'armGroupLabels': ['Digital sleep hygiene education (SHE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Jennifer N Felder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Annually', 'ipdSharing': 'YES', 'description': 'We will share data via the National Database for Clinical Trials related to Mental Illness (NDCT), which is a secure platform for scientific collaboration and data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stanford University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}