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

NCT ID: NCT00601393

Last Updated: 2012-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive treatment as usual followed by 8 weeks of Internet-based cognitive behavioral therapy treatment

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

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.

Treatment as usual (TAU)

Intervention Type OTHER

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.

2

Participants will receive 8 weeks of Internet-based cognitive behavioral therapy treatment

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa B. Sheeber, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

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Oregon Research Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22663903 (View on PubMed)

Other Identifiers

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R01MH070426

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR CT-C

Identifier Type: -

Identifier Source: secondary_id

R01MH070426

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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