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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00601393
First received: January 23, 2008
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Depression
Behavioral: Cognitive behavioral therapy (CBT)
Other: Treatment as usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interactive Internet Intervention for Depressed Mothers

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Dyadic Parent Child Interaction Coding System [ Time Frame: Measured at pretreatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: September 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
Behavioral: Cognitive behavioral therapy (CBT)
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.
Other: Treatment as usual (TAU)
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.
Experimental: 2
Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
Behavioral: Cognitive behavioral therapy (CBT)
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601393

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Lisa B. Sheeber, PhD Oregon Research Institute
  More Information

No publications provided by Oregon Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00601393     History of Changes
Other Study ID Numbers: R01 MH070426, R01MH070426, DSIR CT-C
Study First Received: January 23, 2008
Last Updated: January 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014