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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Web-based CBT for PPD
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring Web-based Intervention, CBT Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa
  • Oregon Research Institute
  • University of Melbourne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Web-based CBT for PPD

Arm Description

Participants will receive Web-based CBT for PPD.

Outcomes

Primary Outcome Measures

Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Clinical utility of the program in ameliorating postpartum depression symptoms

Secondary Outcome Measures

Women's characteristics that moderate the impact of the program

Full Information

First Posted
July 20, 2009
Last Updated
November 21, 2013
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00942721
Brief Title
Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression
Official Title
Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Web-based Intervention, CBT Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Web-based CBT for PPD
Arm Type
Experimental
Arm Description
Participants will receive Web-based CBT for PPD.
Intervention Type
Behavioral
Intervention Name(s)
Web-based CBT for PPD
Intervention Description
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
Primary Outcome Measure Information:
Title
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Time Frame
Measured 3 and 6 months postpartum
Title
Clinical utility of the program in ameliorating postpartum depression symptoms
Time Frame
Measured 3 and 6 months postpartum
Secondary Outcome Measure Information:
Title
Women's characteristics that moderate the impact of the program
Time Frame
Measured 3 and 6 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian G. Danaher, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeannette Milgrom, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Stuart, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Facility Name
University of Melbourne
City
Heidelberg Heights
State/Province
Victoria
ZIP/Postal Code
VIC, 3061
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23612274
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.
Results Reference
background
PubMed Identifier
24191345
Citation
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.
Results Reference
result

Learn more about this trial

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

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