- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00601393
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Interactive Internet Intervention for Depressed Mothers
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
-
Eugene, Oregon, Forente stater, 97403
- Oregon Research Institute
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: 1
Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
|
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.
|
Eksperimentell: 2
Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Center for Epidemiological Studies-Depression (CES-D) Scale
Tidsramme: Measured at pretreatment, post-treatment, and 3-month follow-up
|
Measured at pretreatment, post-treatment, and 3-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Dyadic Parent Child Interaction Coding System
Tidsramme: Measured at pretreatment, post-treatment, and 3-month follow-up
|
Measured at pretreatment, post-treatment, and 3-month follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Lisa B. Sheeber, PhD, Oregon Research Institute
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01MH070426 (U.S. NIH-stipend/kontrakt)
- DSIR CT-C
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Cognitive behavioral therapy (CBT)
-
Medical University of South CarolinaDrug Abuse Research Training ProgramFullført
-
Medical University of South CarolinaNational Institute of Mental Health (NIMH)Påmelding etter invitasjonDepresjon | Depressive symptomerForente stater
-
Medical University of South CarolinaRekrutteringDepresjon | Kreft | Depressive symptomerForente stater
-
Duke UniversityPalliative Care Research Cooperative GroupFullførtAvansert kreftForente stater
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)FullførtOvervekt | Overstadig spiseforstyrrelseForente stater
-
University of New HampshireAvsluttetDepressiv lidelse | Angstlidelser | RusmisbruksforstyrrelserForente stater
-
Nova Scotia Health AuthorityFullførtOverstadig spiseforstyrrelseCanada
-
Nemours Children's ClinicFullførtDiabetes mellitus, type 2 | BarnefedmeForente stater
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA); National Institutes of Health...FullførtDepresjon | Depressive symptomer | UngdomsadferdForente stater
-
Nemours Children's ClinicFullførtDiabetes mellitus, type 2 | BarnefedmeForente stater