Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Eugene, Oregon 97403


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

R01 MH070426


NCT ID:

NCT00601393


Secondary ID:

DSIR CT-C


Study Acronym:


Brief Title:

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


Official Title:

Interactive Internet Intervention for Depressed Mothers


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Mental Health (NIMH)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

70


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Lisa B. Sheeber, PhD
Principal Investigator
Oregon Research Institute

Study Dates

Start Date:September 2006
Completion Date:July 2009
Completion Type:Anticipated
Primary Completion Date:July 2009
Primary Completion Type:Anticipated
Verification Date:March 2009
Last Changed Date:March 12, 2009
First Received Date:January 23, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Dyadic Parent Child Interaction Coding System
Time Frame:Measured at pretreatment, post-treatment, and 3-month follow-up
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Center for Epidemiological Studies-Depression (CES-D) Scale
Time Frame:Measured at pretreatment, post-treatment, and 3-month follow-up
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive behavioral therapy (CBT)
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.
Arm Name:2
Intervention Type:Other
Name:Treatment as usual (TAU)
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.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:2
Description:Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment
Study Arm Type:Active Comparator
Arm Name:1
Description:Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.