Depression, PostpartumPhase 2NCT00601757
Depression Prevention for Pregnant Women on Public Assistance
A Phase 2 study testing The Postpartum Prevention Program (PPP) and Enhanced care as usual (ECU) in people with Depression, Postpartum and Depression, run by Women and Infants Hospital of Rhode Island at 3 sites in United States.
Trial summary
This study will evaluate the effectiveness of an interpersonal therapy treatment called the Postpartum Prevention Program in preventing the development of postpartum depression in pregnant women who are financially disadvantaged. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum, Depression
- What is being tested?
- The Postpartum Prevention Program (PPP) and Enhanced care as usual (ECU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Dec 2012
- Phase
- Phase 2
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speaks and comprehends English sufficiently to complete the study procedures
- Willing and able to receive public assistance
- Between 20 and 34 weeks of gestation
- Score of greater than 27 on the Cooper Risk Survey to identify risk of PPD
Who cannot join
- Currently receiving mental health services from a healthcare provider
- Meets criteria for a current affective disorder, anxiety disorder (excluding simple phobia), substance use disorder, or psychosis, as determined by the relevant modules of the Structured Clinical Interview for DSM-IV Nonpatient Version (SCID-NP)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Womens' Care Inc.
Providence, Rhode Island, 02903
Women and Infants Hospital
Providence, Rhode Island, 02905
Thundermist Health Center
Woonsocket, Rhode Island, 02895
About this study
Official title: Depression Intervention for Financially Disadvantaged Pregnant Women.
This study will evaluate the effectiveness of an interpersonal therapy treatment called the Postpartum Prevention Program in preventing the development of postpartum depression in pregnant women who are financially disadvantaged.
Read the detailed description
Postpartum depression (PPD) occurs in approximately 10% to 16% of mothers who have recently delivered babies. The impact of PPD is profound, causing considerable emotional pain for the mother as well as possible disturbances in infant development and later child adjustment. If left untreated, the mother's depression may cause strain on family life and her relationship with her child. Further research is needed to discover treatments to effectively reduce the risk of experiencing PPD. Despite preliminary findings that suggest that psychosocial treatments may prevent postpartum mood disturbances, few studies have examined the effects of preventive therapy to reduce PPD in women at risk for PPD. An area of even greater neglect is the testing of such a treatment for financially disadvantaged women, who represent a group at high risk for PPD and a group less likely to access treatment for depression than middle-class women. The Postpartum Prevention Program (PPP), an interpersonal therapy program targeting factors that may play a significant role in the development of PPD, may be helpful in reducing the occurrence of PPD. This study will compare the effectiveness of PPP to enhanced care as usual (ECU) in preventing PPD in financially disadvantaged women who are pregnant.
Participation in this single-blind study will last until 1 year after delivery. All potential participants will answer an initial questionnaire concerning stresses that may increase the risk of depression, including relationship and emotional difficulties. Selected participants will then undergo an interview about symptoms of depression, emotional difficulties, and alcohol and drug use. Participants identified as having depression will be provided appropriate referrals for treatment and their study participation will end. Participants invited to continue with the study will be randomly assigned to receive PPP or ECU. Participants assigned to receive PPP will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 2 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access social support resources. Participants assigned to ECU will receive the usual medical care provided for pregnant women, educational material on PPD, and a list of referrals and resources.
All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment; 4 weeks after treatment assignment; 3 weeks after delivery; and 3, 6, and 12 months after delivery. Participants will also be seen briefly at the hospital at the time of delivery and 3, 6, and 12 months after delivery to assess mother-infant relationships. All questionnaires and assessments will take between 60 and 90 minutes to complete.
- Conditions
- Depression, Postpartum, Depression
- Being tested
- The Postpartum Prevention Program (PPP), Enhanced care as usual (ECU)
- Keywords
- Preventive Intervention, Postpartum Depression, Women on Public Assistance
- Medical subject headings
- Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Postpartum Prevention Program (PPP)Behavioural
PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period.
Enhanced care as usual (ECU)Behavioural
ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Participants assigned to the Postpartum Prevention Program Receives: Behavioral: The Postpartum Prevention Program (PPP) |
| 2 | Other | Participants assigned to enhanced care as usual Receives: Behavioral: Enhanced care as usual (ECU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal Interval Follow-up Examination (LIFE)
Measured: Measured at Months 3, 6, and 12 postpartum
Secondary outcomes (1)
Adjustment disorder or depression not otherwise specified (NOS) as measured by the Structured Clinical Interview for DSM Disorders (SCID)
Measured: Measured within Month 6 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Caron Zlotnick, Women and Infants Hospital of Rhode Island
- Investigators
- Caron Zlotnick, PhD, Principal investigator, Women and Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601757
- Sponsor's protocol ID
- R01MH071766
- Other IDs
- R01MH071766, DSIR 83-ATP
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2008
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zlotnick C, Tzilos G, Miller I, Seifer R, Stout R. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affect Disord. 2016 Jan 1;189:263-8. doi: 10.1016/j.jad.2015.09.059. Epub 2015 Sep 30.
PubMed 26454186
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Intervention for Financially Disadvantaged Pregnant Women.
- ClinicalTrials.gov ID
- NCT00601757
- Acronym / sponsor ID
- R01MH071766
- Conditions
- Depression, Postpartum, Depression
- Keywords
- Preventive Intervention, Postpartum Depression, Women on Public Assistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2008 (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 evaluate the effectiveness of an interpersonal therapy treatment called the Postpartum Prevention Program in preventing the development of postpartum depression in pregnant women who are financially disadvantaged.
Detailed description
Postpartum depression (PPD) occurs in approximately 10% to 16% of mothers who have recently delivered babies. The impact of PPD is profound, causing considerable emotional pain for the mother as well as possible disturbances in infant development and later child adjustment. If left untreated, the mother's depression may cause strain on family life and her relationship with her child. Further research is needed to discover treatments to effectively reduce the risk of experiencing PPD. Despite preliminary findings that suggest that psychosocial treatments may prevent postpartum mood disturbances, few studies have examined the effects of preventive therapy to reduce PPD in women at risk for PPD. An area of even greater neglect is the testing of such a treatment for financially disadvantaged women, who represent a group at high risk for PPD and a group less likely to access treatment for depression than middle-class women. The Postpartum Prevention Program (PPP), an interpersonal therapy program targeting factors that may play a significant role in the development of PPD, may be helpful in reducing the occurrence of PPD. This study will compare the effectiveness of PPP to enhanced care as usual (ECU) in preventing PPD in financially disadvantaged women who are pregnant.
Participation in this single-blind study will last until 1 year after delivery. All potential participants will answer an initial questionnaire concerning stresses that may increase the risk of depression, including relationship and emotional difficulties. Selected participants will then undergo an interview about symptoms of depression, emotional difficulties, and alcohol and drug use. Participants identified as having depression will be provided appropriate referrals for treatment and their study participation will end. Participants invited to continue with the study will be randomly assigned to receive PPP or ECU. Participants assigned to receive PPP will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 2 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access social support resources. Participants assigned to ECU will receive the usual medical care provided for pregnant women, educational material on PPD, and a list of referrals and resources.
All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment; 4 weeks after treatment assignment; 3 weeks after delivery; and 3, 6, and 12 months after delivery. Participants will also be seen briefly at the hospital at the time of delivery and 3, 6, and 12 months after delivery to assess mother-infant relationships. All questionnaires and assessments will take between 60 and 90 minutes to complete.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: The Postpartum Prevention Program (PPP)Participants assigned to the Postpartum Prevention Program |
| 2 | Other | Behavioral: Enhanced care as usual (ECU)Participants assigned to enhanced care as usual |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Speaks and comprehends English sufficiently to complete the study procedures
- Willing and able to receive public assistance
- Between 20 and 34 weeks of gestation
- Score of greater than 27 on the Cooper Risk Survey to identify risk of PPD
Key exclusion criteria (2 listed)
- Currently receiving mental health services from a healthcare provider
- Meets criteria for a current affective disorder, anxiety disorder (excluding simple phobia), substance use disorder, or psychosis, as determined by the relevant modules of the Structured Clinical Interview for DSM-IV Nonpatient Version (SCID-NP)
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 |
|---|---|---|
| The Postpartum Prevention Program (PPP)PPP includes interpersonal therapy sessions as well as distribution of educational material on postpartum depression. The group sessions will take place during the participant's last trimester of pregnancy. There will be four weekly sessions prior to delivery and one booster session within the first 2 weeks of the postpartum period. | Behavioural | 1 |
| Enhanced care as usual (ECU)ECU includes the usual medical care provided for pregnant women at the Women's Primary Care Center at Women and Infants Hospital as well as the provision of educational material and a list of treatment resources for postpartum depression. Participants will also receive more intensive follow-up in terms of their mental health status than is typically provided in usual practice. | Behavioural | 2 |
Primary outcome
Longitudinal Interval Follow-up Examination (LIFE)
Time frame: Measured at Months 3, 6, and 12 postpartum
1 secondary outcome
Adjustment disorder or depression not otherwise specified (NOS) as measured by the Structured Clinical Interview for DSM Disorders (SCID)
Time frame: Measured within Month 6 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 31 Jan 2014.
- Derived from this study: PubMed 26454186Zlotnick C, Tzilos G, Miller I, Seifer R, Stout R. Randomized controlled trial to prevent postpartum depression in mothers on public assistance. J Affect Disord. 2016 Jan 1;189:263-8. doi: 10.1016/j.jad.2015.09.059. Epub 2015 Sep 30.
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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.
Caron Zlotnick, PhD principal investigator
Women and Infants Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The Postpartum Prevention Program (PPP) and Enhanced care as usual (ECU) in people with Depression, Postpartum and Depression, run by Women and Infants Hospital of Rhode Island at 3 sites in United States.
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 4 inclusion and 2 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 31 Jan 2014. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Longitudinal Interval Follow-up Examination (LIFE) (time frame: Measured at Months 3, 6, and 12 postpartum). 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 NCT00601757, which also lists 1 linked publication.
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 31 Jan 2014.