Postpartum DepressionNCT01379781
Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
A study testing Behavioral Intervention for PPD in people with Postpartum Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Behavioral Intervention for PPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, non-smoking pregnant women
- Ages 18-35
- Score of 28 or higher on the Predictive Index of Postnatal Depression
- Low to normal obstetric risk
- Before 34 weeks gestation
Who cannot join
- High Risk pregnancy
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids
- Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
- Smoking during pregnancy
- Illicit drug/alcohol use during pregnancy
- Taking any psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.
Read the detailed description
Of the over 4 million live births each year in the United States, nearly 800,000 - or 20% - of the mothers will develop major or minor depression within the first 3 months postpartum. This number dwarfs prevalence rates for gestational diabetes (2-5%) and preterm birth (12.7%). Existing clinical approaches to postpartum depression (PPD) use standard pharmacologic and psychological interventions to reduce women's symptoms. Nevertheless, PPD is undertreated, in part because women are reluctant to seek treatment due to stigma associated with mental health care and disinclination to take psychotropic medications when breastfeeding. The consequences of this are substantial. Untreated PPD is associated with diminished quality of life and significant emotional suffering for women, and, through compromised caregiving, poor outcomes in children's cognitive and social-emotional development. Although maternal risk factors for PPD are well known, protocols for prevention based on commonly used depression interventions are only beginning to be evaluated. Building on developmental data showing the profound bi-directionality of emotional and behavioral influences between mother and infant, the investigators are testing a novel PPD intervention protocol that challenges the standard, individually-focused treatment paradigm. Our intervention is based on the conceptualization of PPD as a potential disorder of the dyad, and one that can be approached through behavioral change in and affective engagement with mother and child. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. The investigators aim to collect data on a novel PPD risk-reducing protocol based on a dyadic behavioral approach to PPD in which the investigators treat at-risk women by promoting maternally-mediated behavioral changes in their infants. The investigators will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits, then evaluate infant behavior at 6 and 14 weeks, and maternal mood at 6, 10, and 14 weeks postpartum. The investigators will fully exploit the investigative opportunities of this intervention study by using state-of-the-art EEG and fetal monitoring to characterize early biomarkers associated with infant behavior and behavior change. This study has the potential to have a major impact on clinical research, and to transform the standard care of PPD in that (1) the intervention will have high rates of treatment compliance because (a) the protocol sessions can be incorporated into usual perinatal medical visits, (b) parenting skills will appeal to women as a non-psychiatric intervention, (c) the clinical approach will have face validity given the dyadic focus of the perinatal period; (2) its aim is prevention; (3) it fosters both maternal and child well being; (4) it will expand the risk factors for PPD to include neurobehavioral markers in the perinate.
- Conditions
- Postpartum Depression
- Being tested
- Behavioral Intervention for PPD
- Keywords
- prevention, postpartum depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention for PPDBehavioural
Also called Preventative Behavioral Intervention for PPD.
We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention for PPD | Experimental | Behavioral Intervention for PPD delivered over 3 in-person sessions. Receives: Behavioral: Behavioral Intervention for PPD |
| Treatment As Usual | No intervention | Referred to Treatment in the Community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scales of Depression
- Assessing severity of depression; clinician rated
- 24 questions
- 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe
- 11 items are scored from 0-2
- A composite score is created by the sum of the scores from all items. Scores can range from 0-74
- 0-7: normal
- 8-13: mild depression
- 14-18: moderate depression
- 19-23: severe depression
- 24: very severe depression
- Higher summed values indicate a greater severity of depression
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Monk, New York State Psychiatric Institute
- Investigators
- Catherine E Monk, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379781
- Sponsor's protocol ID
- #6285
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2011
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
PubMed 37146219
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Change in the Mother-Infant Dyad: Preventing Postpartum Depression
- ClinicalTrials.gov ID
- NCT01379781
- Acronym / sponsor ID
- #6285
- Conditions
- Postpartum Depression
- Keywords
- prevention, postpartum depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum depression (PPD) is undertreated and the consequences of this are substantial for women and children. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. In this study, the investigators are teaching parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to women likely to develop PPD to see if the investigators can prevent the onset of this disorder.
Detailed description
Of the over 4 million live births each year in the United States, nearly 800,000 - or 20% - of the mothers will develop major or minor depression within the first 3 months postpartum. This number dwarfs prevalence rates for gestational diabetes (2-5%) and preterm birth (12.7%). Existing clinical approaches to postpartum depression (PPD) use standard pharmacologic and psychological interventions to reduce women's symptoms. Nevertheless, PPD is undertreated, in part because women are reluctant to seek treatment due to stigma associated with mental health care and disinclination to take psychotropic medications when breastfeeding. The consequences of this are substantial. Untreated PPD is associated with diminished quality of life and significant emotional suffering for women, and, through compromised caregiving, poor outcomes in children's cognitive and social-emotional development. Although maternal risk factors for PPD are well known, protocols for prevention based on commonly used depression interventions are only beginning to be evaluated. Building on developmental data showing the profound bi-directionality of emotional and behavioral influences between mother and infant, the investigators are testing a novel PPD intervention protocol that challenges the standard, individually-focused treatment paradigm. Our intervention is based on the conceptualization of PPD as a potential disorder of the dyad, and one that can be approached through behavioral change in and affective engagement with mother and child. Studies show that infant cry/fuss and sleep behavior are associated with PPD, and that parenting interventions can change infant behavior, yet these findings have never been applied to PPD. The investigators aim to collect data on a novel PPD risk-reducing protocol based on a dyadic behavioral approach to PPD in which the investigators treat at-risk women by promoting maternally-mediated behavioral changes in their infants. The investigators will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits, then evaluate infant behavior at 6 and 14 weeks, and maternal mood at 6, 10, and 14 weeks postpartum. The investigators will fully exploit the investigative opportunities of this intervention study by using state-of-the-art EEG and fetal monitoring to characterize early biomarkers associated with infant behavior and behavior change. This study has the potential to have a major impact on clinical research, and to transform the standard care of PPD in that (1) the intervention will have high rates of treatment compliance because (a) the protocol sessions can be incorporated into usual perinatal medical visits, (b) parenting skills will appeal to women as a non-psychiatric intervention, (c) the clinical approach will have face validity given the dyadic focus of the perinatal period; (2) its aim is prevention; (3) it fosters both maternal and child well being; (4) it will expand the risk factors for PPD to include neurobehavioral markers in the perinate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention for PPD | Experimental | Behavioral: Behavioral Intervention for PPDBehavioral Intervention for PPD delivered over 3 in-person sessions. |
| Treatment As Usual | No intervention | –Referred to Treatment in the Community. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy, non-smoking pregnant women
- Ages 18-35
- Score of 28 or higher on the Predictive Index of Postnatal Depression
- Low to normal obstetric risk
- Before 34 weeks gestation
Key exclusion criteria (6 listed)
- High Risk pregnancy
- Taking medications that affect the cardiovascular system (α blockers, β blockers, corticosteroids
- Chronic-use asthma medications (e.g. beta2-adrenoceptor agonists)
- Smoking during pregnancy
- Illicit drug/alcohol use during pregnancy
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 Intervention for PPDAlso: Preventative Behavioral Intervention for PPD.We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits. | Behavioural | Behavioral Intervention for PPD |
Primary outcome
Hamilton Rating Scales of Depression
Time frame: 6 weeks postpartum
* Assessing severity of depression; clinician rated * 24 questions * 13 items are scored on a 5 point scale ranging from 0=not present to 4=severe * 11 items are scored from 0-2 * A composite score is created by the sum of the scores from all items. Scores can range from 0-74 * 0-7: normal * 8-13: mild depression * 14-18: moderate depression * 19-23: severe depression * 24: very severe depression * Higher summed values indicate a greater severity of depression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37146219Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
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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.
Catherine E Monk, Ph.D. principal investigator
Columbia University
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 Intervention for PPD in people with Postpartum Depression, run by New York State Psychiatric Institute 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 5 inclusion and 6 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 3 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hamilton Rating Scales of Depression (time frame: 6 weeks 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 NCT01379781, 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 3 Jul 2024.