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

Postpartum Depression Clinical Trial

Official title:

Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942721
• Other study ID #: R01MH084931
• Secondary ID: R01MH0849311R01M
• Status: Completed
• Phase: Phase 1
• First received: July 20, 2009
• Last updated: November 21, 2013
• Start date: October 2009
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

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

Locations

Country	Name	City	State
Australia	University of Melbourne	Heidelberg Heights	Victoria
United States	Oregon Research Institute	Eugene	Oregon
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Australia, 

References & Publications (2)

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):e2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability and feasibility of the Web-based treatment program for women with postpartum depression		Measured 3 and 6 months postpartum	No
Primary	Clinical utility of the program in ameliorating postpartum depression symptoms		Measured 3 and 6 months postpartum	No
Secondary	Women's characteristics that moderate the impact of the program		Measured 3 and 6 months postpartum	No