Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 7:35 AM
Study NCT ID:
NCT00601393
Status:
COMPLETED
Last Update Posted:
2012-01-30
First Post:
2008-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-25', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center for Epidemiological Studies-Depression (CES-D) Scale', 'timeFrame': 'Measured at pretreatment, post-treatment, and 3-month follow-up'}], 'secondaryOutcomes': [{'measure': 'Dyadic Parent Child Interaction Coding System', 'timeFrame': 'Measured at pretreatment, post-treatment, and 3-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '22663903', 'type': 'DERIVED', 'citation': 'Sheeber LB, Seeley JR, Feil EG, Davis B, Sorensen E, Kosty DB, Lewinsohn PM. Development and pilot evaluation of an Internet-facilitated cognitive-behavioral intervention for maternal depression. J Consult Clin Psychol. 2012 Oct;80(5):739-749. doi: 10.1037/a0028820. Epub 2012 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effectiveness of an Internet-based cognitive behavioral therapy program in treating mothers with depression who have young children.', 'detailedDescription': 'Being a mother of a young child can be very stressful. Many women find that being a parent may not be as enjoyable as expected and that they feel persistently tired or sad. Because of the possible "lows" of recent motherhood, new mothers are particularly prone to depression. The impact of depression on recent mothers is significant, including emotional distress for the woman as well as possible disturbances in the child\'s development. If left untreated, the mother\'s depression may cause strain on family life and her relationship with her child. Cognitive behavioral therapy (CBT), a form of psychotherapy that can be used to treat people with depression, aims to modify thoughts and behaviors. Despite the availability of helpful CBT programs, most depressed people do not receive treatment. To make these treatments more accessible to mothers who may lack the means to seek help, this study will adapt CBT for depression to an at-home computer-based program. This study will evaluate the effectiveness of the computer-based CBT program in improving the moods of depressed mothers and their children and enhancing the quality of time shared between mother and child.\n\nParticipation in this single-blind study will last at least 8 weeks. A computer, modem, monitor, and Internet connection will be installed in the homes of all participants. Participants will then be randomly assigned to receive either immediate treatment or delayed treatment, which will begin after a wait-list period. Treatment will be delivered on a computer, which will allow the participants to chat online with other parents and their program coach. There will be 11 CBT-related lessons over 8 weeks, taking between 8 and 11 hours total to complete. The lessons will promote self-learning and will include content of particular relevance to mothers of young children, including how to handle stress and improve mood. Participants will be required to contact their coach at least every 2 weeks to review the lessons learned. There will be three assessments, occurring at pretreatment, immediately post-treatment, and 3 months post-treatment. Participants assigned to delayed treatment will complete one additional assessment prior to beginning the wait-list period. Each assessment will involve both parent and child and will include play interactions, questionnaires, and interviews about parenting, feelings, child behavior, moods, and self-esteem. Another caretaker of the child and the child\'s teacher will also be asked to complete questionnaires about the child\'s and/or parent\'s behavior.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of elevated self-reported depressive symptomatology, confirmed by a CES-D score of greater than 21\n* Understands spoken English\n* Either the biological/adoptive mother, permanent legal guardian, or long-term relative caretaker for the child\n* Resides in a stable residence with the infrastructure for phone service that can support Internet access'}, 'identificationModule': {'nctId': 'NCT00601393', 'briefTitle': 'Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Research Institute'}, 'officialTitle': 'Interactive Internet Intervention for Depressed Mothers', 'orgStudyIdInfo': {'id': 'R01MH070426', 'link': 'https://reporter.nih.gov/quickSearch/R01MH070426', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH070426', 'link': 'https://reporter.nih.gov/quickSearch/R01MH070426', 'type': 'NIH'}, {'id': 'DSIR CT-C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)', 'Other: Treatment as usual (TAU)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment', 'interventionNames': ['Behavioral: Cognitive behavioral therapy (CBT)']}], 'interventions': [{'name': 'Cognitive behavioral therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'CBT treatment is delivered via the Internet. Adaptations to the CBT program will include the addition of content of particular relevance to mothers of young children and the incorporation of instructional design principles to promote self-learning. The treatment program will take advantage of the unique properties of the Internet, including multimedia presentations and interactive components with professional and moderated peer social support.', 'armGroupLabels': ['1', '2']}, {'name': 'Treatment as usual (TAU)', 'type': 'OTHER', 'description': 'Participants receiving TAU will be offered the CBT treatment after a wait-list period. During the wait-list period, participants will be offered facilitated referrals to treatment provided in the community.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97403', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Research Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Lisa B. Sheeber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}