- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00942721
Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression
Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Victoria
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Heidelberg Heights, Victoria, Australia, VIC, 3061
- University of Melbourne
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Web-based CBT for PPD
Participants will receive Web-based CBT for PPD.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Time Frame: Measured 3 and 6 months postpartum
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Measured 3 and 6 months postpartum
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Clinical utility of the program in ameliorating postpartum depression symptoms
Time Frame: Measured 3 and 6 months postpartum
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Measured 3 and 6 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Women's characteristics that moderate the impact of the program
Time Frame: Measured 3 and 6 months postpartum
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Measured 3 and 6 months postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian G. Danaher, PhD, Oregon Research Institute
Publications and helpful links
General Publications
- Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Lewinsohn P. Web-Based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Res Protoc. 2012 Nov 22;1(2):e18. doi: 10.2196/resprot.2329.
- Danaher BG, Milgrom J, Seeley JR, Stuart S, Schembri C, Tyler MS, Ericksen J, Lester W, Gemmill AW, Kosty DB, Lewinsohn P. MomMoodBooster web-based intervention for postpartum depression: feasibility trial results. J Med Internet Res. 2013 Nov 4;15(11):e242. doi: 10.2196/jmir.2876.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH084931 (NIH)
- DSIR 83-ATP (NCT00719979)
- 1R01MH084931-01A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Depression
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University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
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University of CoimbraEnrolling by invitationPostPartum DepressionPortugal
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University of MinnesotaNational Institute of Mental Health (NIMH)Completed
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Sage TherapeuticsCompletedSevere Postpartum DepressionUnited States
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Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
Gazi UniversityCompletedPostpartum Depression | Postpartum AdaptationTurkey
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British Columbia Children's HospitalActive, not recruiting
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University of RochesterMae Stone Goode FoundationCompletedPostpartum Depression | Postpartum AnxietyUnited States
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Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
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