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Clinical Trials/NCT00942721
NCT00942721CompletedPhase 1

Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression

Oregon Research Institute3 sites in 2 countries53 target enrollmentStarted: October 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
53
Locations
3
Primary Endpoint
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression

Study Overview

Brief Summary

This study will develop and test a Web-based program to treat women with postpartum depression.

Detailed Description

After a woman gives birth, she will often feel anxious, depressed, or upset. For most women, these feelings go away within a week of giving birth, but for some, postpartum depression (PPD) can develop. PPD involves long-term, more severe feelings of anxiety, depression, and despair that impair normal functioning. Untreated PPD threatens both the mental health of mothers and the development of their infants, but many cases go untreated. This may be because of the stigma of mental health treatment, limited availability of programs, cost of treatment, or difficulty finding the time to schedule trips out of the home. Treatment through a Web-based program addresses all these concerns by providing a private, cost-efficient program available anywhere with computer access. This study will develop and test a Web-based version of cognitive behavioral therapy (CBT) to treat women with PPD to determine its feasibility and acceptability.

Participation in this study will last 3 months. All participants will be offered a Web-based version of CBT for PPD. The CBT program will include guided behavioral strategies for dealing with depression, online videos of women who have used these strategies, Web forums in which participants can ask questions of peers and experts, and periodic phone coaching. The program will last 6 weeks. All participants will complete assessments at baseline, post-treatment, and 3-month follow-up. Safety monitoring questionnaires will also be completed at Weeks 2 and 4 of treatment. Assessments will include clinical interviews and questionnaires related to the following: health; depression; demographics; maternal skills, stress, and self-efficacy; Internet use, experience, and self-efficacy; behavioral self-efficacy; and program acceptability.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Within 6 months postpartum
  • •Home access to the Internet
  • •Use of personal e-mail
  • •Score from 12 to 20, inclusive, on the Edinburgh Postnatal Depression Scale
  • •Diagnosed as having postpartum depression

Exclusion Criteria

  • •Current diagnosis of substance abuse, bipolar disorder, or psychotic depression
  • •Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy
  • •Currently has suicidal intentionality, lethality, access to means, and history of suicide attempts

Arms & Interventions

Web-based CBT for PPD

Experimental

Participants will receive Web-based CBT for PPD.

Intervention: Web-based CBT for PPD (Behavioral)

Outcomes

Primary Outcomes

Acceptability and feasibility of the Web-based treatment program for women with postpartum depression

Time Frame: Measured 3 and 6 months postpartum

Clinical utility of the program in ameliorating postpartum depression symptoms

Time Frame: Measured 3 and 6 months postpartum

Secondary Outcomes

  • Women's characteristics that moderate the impact of the program(Measured 3 and 6 months postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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