Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression

Official Title: “Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression”

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

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.

Intervention(s) in this Clinical Trial

• Behavioral: Web-based cognitive behavioral therapy (CBT) program for postpartum depression (PPD)
  • A cognitive behavioral intervention that will provide participants with the following: online interactive tools to clarify their attitudes and reasons for wanting to change, information about some of the symptoms and mechanisms associated with feeling depressed during the postpartum period, and guidance on using behavioral and cognitive strategies proven to help reduce depressive symptoms

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Web-based CBT for postpartum depression (PPD)
  • Participants will receive Web-based CBT for PPD.

Primary Measures

• Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
  • Time Frame: Measured 3 and 6 months postpartum
    Safety Issue?: No
• Extent to which participants use skills recommended in the program
  • Time Frame: Measured 3 and 6 months postpartum
    Safety Issue?: No
• Clinical utility of the program in ameliorating postpartum depression symptoms
  • Time Frame: Measured 3 and 6 months postpartum
    Safety Issue?: No

Secondary Measures

• Women's characteristics that moderate the impact of the program
  • Time Frame: Measured 3 and 6 months postpartum
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Institute of Mental Health (NIMH) NIH

Overall Clinical Trial Officials and Contacts

Brian G. Danaher, PhD Principal Investigator Oregon Research Institute  

Overall Contact: Brian G. Danaher, PhD 541-484-2123 briand@ori.org

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00942721

Study ID Number: R01 MH084931

ClinicalTrials.gov Identifier: NCT00942721

Health Authority: United States: Federal Government