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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00942721
First received: July 20, 2009
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Postpartum Depression
Behavioral: Web-based CBT for PPD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Acceptability and feasibility of the Web-based treatment program for women with postpartum depression [ Time Frame: Measured 3 and 6 months postpartum ] [ Designated as safety issue: No ]
  • Clinical utility of the program in ameliorating postpartum depression symptoms [ Time Frame: Measured 3 and 6 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Women's characteristics that moderate the impact of the program [ Time Frame: Measured 3 and 6 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: October 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942721

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Australia, Victoria
University of Melbourne
Heidelberg Heights, Victoria, Australia, VIC, 3061
Sponsors and Collaborators
Oregon Research Institute
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
  More Information

Publications:
Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00942721     History of Changes
Other Study ID Numbers: R01 MH084931, R01MH084931, 1R01MH084931-01A1, DSIR 83-ATP
Study First Received: July 20, 2009
Last Updated: November 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
Web-based Intervention
CBT Treatment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on July 29, 2014