NCT00942721

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

3.5 years

First QC Date

July 20, 2009

Last Update Submit

November 21, 2013

Conditions

Postpartum Depression

Keywords

Web-based InterventionCBT Treatment

Outcome Measures

Primary Outcomes (2)

  • Acceptability and feasibility of the Web-based treatment program for women with postpartum depression

    Measured 3 and 6 months postpartum

  • Clinical utility of the program in ameliorating postpartum depression symptoms

    Measured 3 and 6 months postpartum

Secondary Outcomes (1)

  • Women's characteristics that moderate the impact of the program

    Measured 3 and 6 months postpartum

Study Arms (1)

Web-based CBT for PPD

EXPERIMENTAL

Participants will receive Web-based CBT for PPD.

Behavioral: Web-based CBT for PPD

Interventions

Web-based CBT for PPDBEHAVIORAL

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

Web-based CBT for PPD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

University of Melbourne

Heidelberg Heights, Victoria, VIC, 3061, Australia

Location

Related Publications (2)

  • 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.

    PMID: 23612274BACKGROUND

  • 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.

    PMID: 24191345RESULT

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Brian G. Danaher, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

  • Jeannette Milgrom, PhD

    University of Melbourne

    PRINCIPAL INVESTIGATOR

  • Scott Stuart, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

AU(1)US(2)