NCT00601393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

3.8 years

First QC Date

January 23, 2008

Last Update Submit

January 25, 2012

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Center for Epidemiological Studies-Depression (CES-D) Scale

    Measured at pretreatment, post-treatment, and 3-month follow-up

Secondary Outcomes (1)

  • Dyadic Parent Child Interaction Coding System

    Measured at pretreatment, post-treatment, and 3-month follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

EXPERIMENTAL

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

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Cognitive behavioral therapy (CBT)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.

12
Treatment as usual (TAU)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.

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • 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.

    PMID: 22663903DERIVED

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lisa B. Sheeber, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

January 28, 2008

Study Start

September 1, 2006

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

US(1)