Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Treatment as usual (TAU)
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Oregon Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
Outcomes
Primary Outcome Measures
Center for Epidemiological Studies-Depression (CES-D) Scale
Secondary Outcome Measures
Dyadic Parent Child Interaction Coding System
Full Information
NCT ID
NCT00601393
First Posted
January 23, 2008
Last Updated
January 25, 2012
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00601393
Brief Title
Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
Official Title
Interactive Internet Intervention for Depressed Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of an Internet-based cognitive behavioral therapy program in treating mothers with depression who have young children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Center for Epidemiological Studies-Depression (CES-D) Scale
Time Frame
Measured at pretreatment, post-treatment, and 3-month follow-up
Secondary Outcome Measure Information:
Title
Dyadic Parent Child Interaction Coding System
Time Frame
Measured at pretreatment, post-treatment, and 3-month follow-up
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa B. Sheeber, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22663903
Citation
Sheeber LB, Seeley JR, Feil EG, Davis B, Sorensen E, Kosty DB, Lewinsohn PM. Development and pilot evaluation of an Internet-facilitated cognitive-behavioral intervention for maternal depression. J Consult Clin Psychol. 2012 Oct;80(5):739-749. doi: 10.1037/a0028820. Epub 2012 Jun 4.
Results Reference
derived
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Effectiveness of Internet-Based Cognitive Behavioral Therapy for Treating Mothers With Depression
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