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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00942721




Registration number
NCT00942721
Ethics application status
Date submitted
20/07/2009
Date registered
21/07/2009
Date last updated
25/11/2013

Titles & IDs
Public title
Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression
Scientific title
Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
Secondary ID [1] 0 0
R01MH084931
Secondary ID [2] 0 0
R01MH084931
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postpartum Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Web-based CBT for PPD

Experimental: Web-based CBT for PPD - Participants will receive Web-based CBT for PPD.


Behaviour: 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
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Timepoint [1] 0 0
Measured 3 and 6 months postpartum
Primary outcome [2] 0 0
Clinical utility of the program in ameliorating postpartum depression symptoms
Timepoint [2] 0 0
Measured 3 and 6 months postpartum
Secondary outcome [1] 0 0
Women's characteristics that moderate the impact of the program
Timepoint [1] 0 0
Measured 3 and 6 months postpartum

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2013
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
VIC, 3061 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Oregon

Funding & Sponsors
Primary sponsor type
Other
Name
Oregon Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Mental Health (NIMH)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will develop and test a Web-based program to treat women with postpartum
depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00942721
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Brian G. Danaher, PhD
Address 0 0
Oregon Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00942721