Depression, PostpartumNCT00951717
Using a Preparation and Education Intervention to Reduce Postpartum Depression Among New Mothers (The MADE IT 2 Study)
A study testing Behavioral education intervention in people with Depression, Postpartum and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Depression
- What is being tested?
- Behavioral education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2010
- Phase
- Interventional
- 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
- Patient in the Maternity Unit at Mount Sinai Hospital
- Infant has a birth weight greater than or equal to 2,500 grams
- Infant has a 5-minute Apgar score greater than or equal to 7
- Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
- Speaks English
- Has a working telephone
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
This study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.
Read the detailed description
Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms.
This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail.
Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.
- Conditions
- Depression, Postpartum, Depression
- Being tested
- Behavioral education intervention
- Keywords
- Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding
- Medical subject headings
- Depression, Postpartum, Depression, Colic, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral education interventionBehavioural
One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail. |
| Behavioral education | Experimental | Participants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail. Receives: Behavioral: Behavioral education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: Measured at baseline
Depressive symptoms
Measured: Measured at 3 weeks
Depressive symptoms
Measured: Measured at 3 months
Depressive symptoms
Measured: Measured at 6 months
Secondary outcomes (8)
Breastfeeding continuation rate
Measured: Measured at baseline
Breastfeeding continuation rate
Measured: Measured at 3 weeks
Breastfeeding continuation rate
Measured: Measured at 3 months
Breastfeeding continuation rate
Measured: Measured at 6 months
Physical functioning
Measured: Measured at baseline
Physical functioning
Measured: Measured at 3 weeks
Physical functioning
Measured: Measured at 3 months
Physical functioning
Measured: Measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Howell, MD, MPP, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951717
- Sponsor's protocol ID
- 05-1062
- Other IDs
- R01MH077683, DSIR 83-ATP
- Status last verified
- Nov 2011
- First submitted
- 3 Aug 2009
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.
PubMed 27227751Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.
PubMed 25374288Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.
PubMed 24019052Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.
PubMed 22581378
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation and Patient Education to Reduce Postpartum Depressive Symptoms
- ClinicalTrials.gov ID
- NCT00951717
- Acronym / sponsor ID
- 05-1062
- Conditions
- Depression, Postpartum, Depression
- Keywords
- Postpartum Depressive Symptoms, Physical Symptoms, Emotional Symptoms, Infant Colic, Social Support, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Aug 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 test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.
Detailed description
Postpartum depression (PPD) is a disorder affecting many women after delivery of a child. Up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. Some situational factors that place mothers at risk of PPD may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. Preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. This study will test the efficacy of a brief intervention that aims to prevent PPD by preparing mothers to deal with stressful triggers and depressive symptoms.
This study will last 6 months. Participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. The intervention will involve two parts. First, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about PPD. Then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. If a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. All participants will receive a list of community and hospital resources by mail.
Study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. At these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Participants will receive standard postpartum education and discharge materials provided by the hospital and a list of community and Internet resources by mail. |
| Behavioral education | Experimental | Behavioral: Behavioral education interventionParticipants will receive behavioral education on postpartum depression and a list of community and Internet resources by mail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient in the Maternity Unit at Mount Sinai Hospital
- Infant has a birth weight greater than or equal to 2,500 grams
- Infant has a 5-minute Apgar score greater than or equal to 7
- Self-identifies as White or minority other than Black or Hispanic; Black and Hispanic women will be referred to a parallel study with the same protocol at Mount Sinai Hospital
- Speaks English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Behavioral education interventionOne education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed | Behavioural | Behavioral education |
Primary outcome
Depressive symptoms
Time frame: Measured at baseline
Depressive symptoms
Time frame: Measured at 3 weeks
Depressive symptoms
Time frame: Measured at 3 months
Depressive symptoms
Time frame: Measured at 6 months
8 secondary outcomes
Breastfeeding continuation rate
Time frame: Measured at baseline
Breastfeeding continuation rate
Time frame: Measured at 3 weeks
Breastfeeding continuation rate
Time frame: Measured at 3 months
Breastfeeding continuation rate
Time frame: Measured at 6 months
Physical functioning
Time frame: Measured at baseline
Physical functioning
Time frame: Measured at 3 weeks
Physical functioning
Time frame: Measured at 3 months
Physical functioning
Time frame: Measured at 6 months
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 22 Nov 2011.
- Derived from this study: PubMed 27227751Bodnar-Deren S, Klipstein K, Fersh M, Shemesh E, Howell EA. Suicidal Ideation During the Postpartum Period. J Womens Health (Larchmt). 2016 Dec;25(12):1219-1224. doi: 10.1089/jwh.2015.5346. Epub 2016 May 26.
- Derived from this study: PubMed 25374288Balbierz A, Bodnar-Deren S, Wang JJ, Howell EA. Maternal depressive symptoms and parenting practices 3-months postpartum. Matern Child Health J. 2015 Jun;19(6):1212-9. doi: 10.1007/s10995-014-1625-6.
- Derived from this study: PubMed 24019052Howell EA, Bodnar-Deren S, Balbierz A, Loudon H, Mora PA, Zlotnick C, Wang J, Leventhal H. An intervention to reduce postpartum depressive symptoms: a randomized controlled trial. Arch Womens Ment Health. 2014 Feb;17(1):57-63. doi: 10.1007/s00737-013-0381-8. Epub 2013 Sep 10.
- Derived from this study: PubMed 22581378Negron R, Martin A, Almog M, Balbierz A, Howell EA. Social support during the postpartum period: mothers' views on needs, expectations, and mobilization of support. Matern Child Health J. 2013 May;17(4):616-23. doi: 10.1007/s10995-012-1037-4.
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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.
Elizabeth Howell, MD, MPP principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral education intervention in people with Depression, Postpartum and Depression, run by Icahn School of Medicine at Mount Sinai at 1 site 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 6 inclusion and 0 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 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Depressive symptoms (time frame: Measured at baseline). The study lists 4 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 NCT00951717, which also lists 4 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 22 Nov 2011; AzTrials last refreshed its copy on 26 Oct 2026.