- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00601393
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Interactive Internet Intervention for Depressed Mothers
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Participation 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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Oregon
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Eugene, Oregon, Vereinigte Staaten, 97403
- Oregon Research Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Evidence of elevated self-reported depressive symptomatology, confirmed by a CES-D score of greater than 21
- Understands spoken English
- Either the biological/adoptive mother, permanent legal guardian, or long-term relative caretaker for the child
- Resides in a stable residence with the infrastructure for phone service that can support Internet access
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 1
Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
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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.
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.
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Experimental: 2
Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Center for Epidemiological Studies-Depression (CES-D) Scale
Zeitfenster: Measured at pretreatment, post-treatment, and 3-month follow-up
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Measured at pretreatment, post-treatment, and 3-month follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Dyadic Parent Child Interaction Coding System
Zeitfenster: Measured at pretreatment, post-treatment, and 3-month follow-up
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Measured at pretreatment, post-treatment, and 3-month follow-up
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Lisa B. Sheeber, PhD, Oregon Research Institute
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R01MH070426 (US NIH Stipendium/Vertrag)
- DSIR CT-C
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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