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

November 21, 2013 updated by: Oregon Research Institute

Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

53

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Heidelberg Heights, Victoria, Australia, VIC, 3061
        • University of Melbourne
  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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
Measured 3 and 6 months postpartum
Clinical utility of the program in ameliorating postpartum depression symptoms
Time Frame: Measured 3 and 6 months postpartum
Measured 3 and 6 months postpartum

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
Measured 3 and 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Brian G. Danaher, PhD, Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

July 20, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (ESTIMATE)

July 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

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.

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