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

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ClinicalTrials.gov Identifier: NCT00942721
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will develop and test a Web-based program to treat women with postpartum depression.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Web-based CBT for PPD Phase 1

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  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
Study Start Date : October 2009
Primary Completion Date : April 2013
Study Completion Date : April 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Web-based CBT for PPD
Participants will receive Web-based CBT for PPD.
Behavioral: Web-based CBT for 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


Outcome Measures

Primary Outcome Measures :
  1. Acceptability and feasibility of the Web-based treatment program for women with postpartum depression [ Time Frame: Measured 3 and 6 months postpartum ]
  2. Clinical utility of the program in ameliorating postpartum depression symptoms [ Time Frame: Measured 3 and 6 months postpartum ]

Secondary Outcome Measures :
  1. Women's characteristics that moderate the impact of the program [ Time Frame: Measured 3 and 6 months postpartum ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942721


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Australia, Victoria
University of Melbourne
Heidelberg Heights, Victoria, Australia, VIC, 3061
Sponsors and Collaborators
Oregon Research Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Brian G. Danaher, PhD Oregon Research Institute
Principal Investigator: Jeannette Milgrom, PhD University of Melbourne
Principal Investigator: Scott Stuart, MD University of Iowa