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

• Sponsor: Oregon Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00942721
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 53
• Locations: 3
• Arm: 1
• Duration (Months): 42
• Patients Per Site: 17.7
• Patients Per Site Per Month: 0.4

Study Details

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
• 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: Oct 1, 2009
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

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 [Measured 3 and 6 months postpartum]

2. Clinical utility of the program in ameliorating postpartum depression symptoms [Measured 3 and 6 months postpartum]

Secondary Outcome Measures

1. Women's characteristics that moderate the impact of the program [Measured 3 and 6 months postpartum]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242
2	Oregon Research Institute	Eugene	Oregon	United States	97403
3	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

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Oregon Research Institute
• ClinicalTrials.gov Identifier: NCT00942721
• Other Study ID Numbers: R01MH084931; R01MH084931; 1R01MH084931-01A1; DSIR 83-ATP
• First Posted: Jul 21, 2009
• Last Update Posted: Nov 25, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Oregon Research Institute: Web-based Intervention; CBT Treatment
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

No Results Posted as of Nov 25, 2013