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Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression

25. januar 2012 opdateret af: Oregon Research Institute

Interactive Internet Intervention for Depressed Mothers

This study will evaluate the effectiveness of an Internet-based cognitive behavioral therapy program in treating mothers with depression who have young children.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Oregon
      • Eugene, Oregon, Forenede Stater, 97403
        • Oregon Research Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Lisa B. Sheeber, PhD, Oregon Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2006

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

23. januar 2008

Først indsendt, der opfyldte QC-kriterier

23. januar 2008

Først opslået (Skøn)

28. januar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. januar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2012

Sidst verificeret

1. januar 2012

Mere information

Begreber relateret til denne undersøgelse

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

Kliniske forsøg med Cognitive behavioral therapy (CBT)

3
Abonner