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Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
This study is ongoing, but not recruiting participants.
Study NCT00601393   Information provided by National Institute of Mental Health (NIMH)
First Received: January 23, 2008   Last Updated: March 12, 2009   History of Changes

January 23, 2008
March 12, 2009
September 2006
July 2009   (final data collection date for primary outcome measure)
Center for Epidemiological Studies-Depression (CES-D) Scale [ Time Frame: Measured at pretreatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601393 on ClinicalTrials.gov Archive Site
Dyadic Parent Child Interaction Coding System [ Time Frame: Measured at pretreatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]
Same as current
 
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Depression
  • Behavioral: Cognitive behavioral therapy (CBT)
  • Other: Treatment as usual (TAU)
  • Active Comparator: Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
  • Experimental: Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
70
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00601393
Lisa Sheeber, Oregon Research Institute
R01 MH070426, DSIR CT-C
National Institute of Mental Health (NIMH)
 
Principal Investigator: Lisa B. Sheeber, PhD Oregon Research Institute
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP