- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00601393
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Interactive Internet Intervention for Depressed Mothers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97403
- Oregon Research Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lisa B. Sheeber, PhD, Oregon Research Institute
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH070426 (U.S. NIH-bevilling/kontrakt)
- DSIR CT-C
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Depression
-
ProgenaBiomeRekrutteringDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
-
Washington University School of MedicineAfsluttetBehandlingsresistent depression | Senlivsdepression | Geriatrisk depression | Refraktær depression | Terapi-resistent depressionForenede Stater, Canada
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RekrutteringDepression Moderat | Depression Alvorlig | Depression MildBelgien
-
University of California, San FranciscoRekrutteringDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
-
Baylor College of MedicineUniversity of TexasRekrutteringDepression | Depression Moderat | Depression Alvorlig | Selvmord og selvskade | Depression i ungdomsårene | Depression MildForenede Stater
-
Charite University, Berlin, GermanyAfsluttetBehandlingsresistent depression | Depression, Unipolar | Depression KroniskTyskland
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
-
Ludwig-Maximilians - University of MunichAfsluttetTerapi-resistent svær depressionTyskland
-
University of California, San FranciscoIkke rekrutterer endnuDepression Moderat | Depression MildForenede Stater
Kliniske forsøg med Cognitive behavioral therapy (CBT)
-
Medical University of South CarolinaDrug Abuse Research Training ProgramAfsluttet
-
University Hospital, Clermont-FerrandNational Cancer Institute, FranceRekrutteringOphør med tobaksbrugFrankrig
-
University Hospital, Clermont-FerrandFondation de l'Avenir, FranceUkendtAfhængighed | Kokain-relaterede lidelserFrankrig
-
Fred Hutchinson Cancer CenterUniversity of WashingtonAfsluttet
-
Nova Scotia Health AuthorityAfsluttetBinge Eating DisorderCanada
-
Karolinska InstitutetLinkoeping University; Stockholm UniversityAfsluttet
-
UConn HealthNational Institute on Drug Abuse (NIDA)Afsluttet
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Kaiser...Afsluttet
-
Fred Hutchinson Cancer CenterKaiser PermanenteAfsluttet
-
Dartmouth-Hitchcock Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Afsluttet