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

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

Detailed Description
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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.

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

Conditions
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Postpartum Depression

Intervention / Treatment
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* Behavioral: Web-based CBT for PPD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based CBT for PPD<br>Participants will receive Web-based CBT for PPD. | Behavioral: Web-based CBT for PPD<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and feasibility of the Web-based treatment program for women with postpartum depression |  | Measured 3 and 6 months postpartum | 
| Clinical utility of the program in ameliorating postpartum depression symptoms |  | Measured 3 and 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Women's characteristics that moderate the impact of the program |  | Measured 3 and 6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Web-based Intervention, CBT Treatment