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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00942721 |
Purpose
This study will develop and test a Web-based program to treat women with postpartum depression.
| Condition | Intervention | Phase |
|---|---|---|
|
Postpartum Depression |
Behavioral: Web-based cognitive behavioral therapy (CBT) program for postpartum depression (PPD) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression |
| Estimated Enrollment: | 122 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Web-based CBT for postpartum depression (PPD)
Participants will receive Web-based CBT for PPD.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brian G. Danaher, PhD | 541-484-2123 | briand@ori.org |
| United States, Iowa | |
| University of Iowa | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Scott Stuart, MD scott-stuart@uiowa.edu | |
| Principal Investigator: Scott Stuart, MD | |
| United States, Oregon | |
| Oregon Research Institute | Not yet recruiting |
| Eugene, Oregon, United States, 97403 | |
| Contact: Brian G. Danaher, PhD 541-484-2123 briand@ori.org | |
| Principal Investigator: Brian G. Danaher, PhD | |
| Australia, Victoria | |
| University of Melbourne | Not yet recruiting |
| Heidelberg Heights, Victoria, Australia, VIC, 3061 | |
| Contact: Jeannette Milgrom, PhD Barbara.FRAZER@austin.org.au | |
| Principal Investigator: Jeannette Milgrom, PhD | |
| 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 |
More Information
| Responsible Party: | Brian G. Danaher, PhD, Oregon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00942721 History of Changes |
| Other Study ID Numbers: | R01 MH084931, 1R01MH084931-01A1, DSIR 83-ATP |
| Study First Received: | July 20, 2009 |
| Last Updated: | August 3, 2009 |
| Health Authority: | United States: Federal Government |
|
Web-based Intervention CBT Treatment |
|
Depression Depressive Disorder Depression, Postpartum Behavioral Symptoms |
Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |