Postpartum DepressionPhase 1NCT00942721
Cognitive Behavioral Therapy Delivered Over the Internet for Women With Postpartum Depression
A Phase 1 study testing Web-based CBT for PPD in people with Postpartum Depression, run by Oregon Research Institute at 3 sites in 2 countries.
Trial summary
This study will develop and test a Web-based program to treat women with postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Web-based CBT for PPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Oct 2009to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
University of Iowa
Iowa City, Iowa, 52242
Australia1 site
University of Melbourne
Heidelberg Heights, Victoria, VIC, 3061
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- Web-based CBT for PPD
- Keywords
- Web-based Intervention, CBT Treatment
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based CBT for PPDBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Web-based CBT for PPD | Experimental | Participants will receive Web-based CBT for PPD. Receives: Behavioral: Web-based CBT for PPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Measured: Measured 3 and 6 months postpartum
Clinical utility of the program in ameliorating postpartum depression symptoms
Measured: Measured 3 and 6 months postpartum
Secondary outcomes (1)
Women's characteristics that moderate the impact of the program
Measured: Measured 3 and 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Brian G. Danaher, PhD, Principal investigator, Oregon Research InstituteJeannette Milgrom, PhD, Principal investigator, University of MelbourneScott Stuart, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942721
- Sponsor's protocol ID
- R01MH084931
- Other IDs
- R01MH084931, 1R01MH084931-01A1, DSIR 83-ATP
- Status last verified
- Nov 2013
- First submitted
- 20 Jul 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23612274Danaher 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.
PubMed 24191345
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-Based Cognitive Behavioral Intervention for Women With Postpartum Depression
- ClinicalTrials.gov ID
- NCT00942721
- Acronym / sponsor ID
- R01MH084931
- Conditions
- Postpartum Depression
- Keywords
- Web-based Intervention, CBT Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based CBT for PPD | Experimental | Behavioral: Web-based CBT for PPDParticipants will receive Web-based CBT for PPD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based CBT for PPDA 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 | Behavioural | Web-based CBT for PPD |
Primary outcome
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression
Time frame: Measured 3 and 6 months postpartum
Clinical utility of the program in ameliorating postpartum depression symptoms
Time frame: Measured 3 and 6 months postpartum
1 secondary outcome
Women's characteristics that moderate the impact of the program
Time frame: Measured 3 and 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Background: PubMed 23612274Danaher 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 publication: PubMed 24191345Danaher 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian G. Danaher, PhD principal investigator
Oregon Research Institute
Jeannette Milgrom, PhD principal investigator
University of Melbourne
Scott Stuart, MD principal investigator
University of Iowa
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Web-based CBT for PPD in people with Postpartum Depression, run by Oregon Research Institute at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability and feasibility of the Web-based treatment program for women with postpartum depression (time frame: Measured 3 and 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00942721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.