DepressionPhase 4NCT00251043
Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Site
A Phase 4 study testing Interpersonal psychotherapy for depression in pregnancy and Parenting education program (PEP) in people with Depression, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of interpersonal psychotherapy in treating pregnant women with depression. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal psychotherapy for depression in pregnancy and Parenting education program (PEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Apr 2010
- Phase
- Phase 4
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Depressed Pregnant women between 18-45 years
- Meets diagnostic criteria for a major depressive disorder
- Reads and understands English or Spanish
- Physically healthy without serious medical illness
- Between 12 and 33 weeks gestation
- Meets diagnostic criteria of DSM-V for a major depressive disorder
- HAM-D score > 12
- EPDS>10
Who cannot join
- Drug or alcohol abuse in the 6 months prior to study entry
- Acute risk for suicide
- Clinically significant co-morbid Axis1 disorders
- High risk pregnancy or medical conditions that affect pregnancy when participation in the study will add to risk or compromise the medical condition
- History of or present non-drug induced psychosis
- Currently taking antidepressant medication
- Exclude severe (HAM-D (17 items) score >24) depression prominent vegetative symptoms and or loss of appetite
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites
This study will evaluate the effectiveness of interpersonal psychotherapy in treating pregnant women with depression.
Read the detailed description
The prevalence of antepartum depression (APD) increases twofold in women with poor social supports, low socioeconomic status (SES), and negative life events. APD may cause low birth weight, premature labor, and eclampsia. APD is also one of the best predictors of postpartum depression (PPD), which in turn may lead to impaired emotional and cognitive development of the infant. Therefore, early treatment of APD is important for the well-being of both the woman and her infant. Forms of psychotherapy have been successful in treating depression in the general population, but more research is necessary to determine the safest and most effective means of treating depression in pregnant women. Interpersonal psychotherapy targets interpersonal events and relationships. Interpersonal psychotherapy adapted for ADP may be effective in reducing depression, preventing PPD, and improving maternal infant attachment. This study will compare the effectiveness of interpersonal psychotherapy for depression in pregnancy (IPT-P) with a parenting education program (PEP) in treating depressed pregnant women who may be affected by SES and psychosocial factors.
Participation in this single-blind study will last through 6 months postpartum. Potential participants will first undergo initial screening, which will include a 90-minute interview with a psychiatrist and a mood assessment with an independent evaluator. Eligible participants will then be randomly assigned to receive 12 weeks of either IPT-P or PEP. Participants in both groups will attend 45-minute weekly sessions prior to delivery of their babies. At each visit, participants will complete questionnaires about mood, anxiety, mother-infant bonding, and daily function. Participants receiving IPT-P will learn ways to address emotional stressors associated with childbirth and will be regularly contacted by a therapist to discuss feelings and emotions. Participants receiving PEP will learn about the stages of pregnancy, childbirth, and early infant development.
After delivery, participants will receive weekly phone calls from a therapist during the first 4 weeks. All participants will then return for five evaluation visits, occurring at Weeks 4, 8, 12, 26, and 24 postpartum. During these visits, a therapist will evaluate participants' moods and mother-infant attachment and will refer participants to treatment if needed. The first four visits will be individual evaluations and the last visit will be a group meeting with other mothers and their infants.
- Conditions
- Depression
- Being tested
- Interpersonal psychotherapy for depression in pregnancy, Parenting education program (PEP)
- Keywords
- Pregnancy, Antepartum Depression, Major Depression
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal psychotherapy for depression in pregnancyBehavioural
Also called psychotherapy
IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.
Parenting education program (PEP)Behavioural
Also called PEP
PEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will Psychotherapy weekly for 12 weeks Receives: Behavioral: Interpersonal psychotherapy for depression in pregnancy |
| 2 | Active comparator | Parenting Education will include 45-minute weekly sessions for 12 week Receives: Behavioral: Parenting education program (PEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Measured: Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum
Secondary outcomes (1)
Mother-infant bonding
Measured: Measured at Weeks 4, 8, 12, 16, and 24 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startSep 2005
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Margaret G. Spinelli, MD, Principal investigator, New York State Psychiatric InstituteJean Endicott, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251043
- Sponsor's protocol ID
- #4830/6040R
- Other IDs
- R01MH069915, R01MH069915-01A2, 4830/6040R
- Status last verified
- Mar 2012
- First submitted
- 7 Nov 2005
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spinelli MG, Endicott J. Controlled clinical trial of interpersonal psychotherapy versus parenting education program for depressed pregnant women. Am J Psychiatry. 2003 Mar;160(3):555-62. doi: 10.1176/appi.ajp.160.3.555.
PubMed 12611838Spinelli MG, Endicott J, Goetz RR, Segre LS. Reanalysis of efficacy of interpersonal psychotherapy for antepartum depression versus parenting education program: initial severity of depression as a predictor of treatment outcome. J Clin Psychiatry. 2016 Apr;77(4):535-40. doi: 10.4088/JCP.15m09787.
PubMed 27137422Spinelli MG, Endicott J, Goetz RR. Disagreement between therapist raters and independent evaluators in a controlled clinical trial of interpersonal psychotherapy for depressed pregnant women. J Psychiatr Pract. 2015 Mar;21(2):114-23. doi: 10.1097/01.pra.0000462604.79606.4e.
PubMed 25782762Spinelli MG, Endicott J, Goetz RR. Increased breastfeeding rates in black women after a treatment intervention. Breastfeed Med. 2013 Dec;8(6):479-84. doi: 10.1089/bfm.2013.0051. Epub 2013 Aug 24.
PubMed 23971683Spinelli MG, Endicott J, Leon AC, Goetz RR, Kalish RB, Brustman LE, Carmona YR, Meyreles Q, Vega M, Schulick JL. A controlled clinical treatment trial of interpersonal psychotherapy for depressed pregnant women at 3 New York City sites. J Clin Psychiatry. 2013 Apr;74(4):393-9. doi: 10.4088/JCP.12m07909.
PubMed 23656847
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites
- ClinicalTrials.gov ID
- NCT00251043
- Acronym / sponsor ID
- #4830/6040R
- Conditions
- Depression
- Keywords
- Pregnancy, Antepartum Depression, Major Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2005
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 9 Nov 2005 (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 interpersonal psychotherapy in treating pregnant women with depression.
Detailed description
The prevalence of antepartum depression (APD) increases twofold in women with poor social supports, low socioeconomic status (SES), and negative life events. APD may cause low birth weight, premature labor, and eclampsia. APD is also one of the best predictors of postpartum depression (PPD), which in turn may lead to impaired emotional and cognitive development of the infant. Therefore, early treatment of APD is important for the well-being of both the woman and her infant. Forms of psychotherapy have been successful in treating depression in the general population, but more research is necessary to determine the safest and most effective means of treating depression in pregnant women. Interpersonal psychotherapy targets interpersonal events and relationships. Interpersonal psychotherapy adapted for ADP may be effective in reducing depression, preventing PPD, and improving maternal infant attachment. This study will compare the effectiveness of interpersonal psychotherapy for depression in pregnancy (IPT-P) with a parenting education program (PEP) in treating depressed pregnant women who may be affected by SES and psychosocial factors.
Participation in this single-blind study will last through 6 months postpartum. Potential participants will first undergo initial screening, which will include a 90-minute interview with a psychiatrist and a mood assessment with an independent evaluator. Eligible participants will then be randomly assigned to receive 12 weeks of either IPT-P or PEP. Participants in both groups will attend 45-minute weekly sessions prior to delivery of their babies. At each visit, participants will complete questionnaires about mood, anxiety, mother-infant bonding, and daily function. Participants receiving IPT-P will learn ways to address emotional stressors associated with childbirth and will be regularly contacted by a therapist to discuss feelings and emotions. Participants receiving PEP will learn about the stages of pregnancy, childbirth, and early infant development.
After delivery, participants will receive weekly phone calls from a therapist during the first 4 weeks. All participants will then return for five evaluation visits, occurring at Weeks 4, 8, 12, 26, and 24 postpartum. During these visits, a therapist will evaluate participants' moods and mother-infant attachment and will refer participants to treatment if needed. The first four visits will be individual evaluations and the last visit will be a group meeting with other mothers and their infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Interpersonal psychotherapy for depression in pregnancyParticipants will Psychotherapy weekly for 12 weeks |
| 2 | Active comparator | Behavioral: Parenting education program (PEP)Parenting Education will include 45-minute weekly sessions for 12 week |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Depressed Pregnant women between 18-45 years
- Meets diagnostic criteria for a major depressive disorder
- Reads and understands English or Spanish
- Physically healthy without serious medical illness
- Between 12 and 33 weeks gestation
Key exclusion criteria (7 listed)
- Drug or alcohol abuse in the 6 months prior to study entry
- Acute risk for suicide
- Clinically significant co-morbid Axis1 disorders
- High risk pregnancy or medical conditions that affect pregnancy when participation in the study will add to risk or compromise the medical condition
- History of or present non-drug induced psychosis
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 |
|---|---|---|
| Interpersonal psychotherapy for depression in pregnancyAlso: psychotherapyIPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth. | Behavioural | 1 |
| Parenting education program (PEP)Also: PEPPEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development. | Behavioural | 2 |
Primary outcome
Depression
Time frame: Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum
1 secondary outcome
Mother-infant bonding
Time frame: Measured at Weeks 4, 8, 12, 16, and 24 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 26 Mar 2012.
- Background: PubMed 12611838Spinelli MG, Endicott J. Controlled clinical trial of interpersonal psychotherapy versus parenting education program for depressed pregnant women. Am J Psychiatry. 2003 Mar;160(3):555-62. doi: 10.1176/appi.ajp.160.3.555.
- Derived from this study: PubMed 27137422Spinelli MG, Endicott J, Goetz RR, Segre LS. Reanalysis of efficacy of interpersonal psychotherapy for antepartum depression versus parenting education program: initial severity of depression as a predictor of treatment outcome. J Clin Psychiatry. 2016 Apr;77(4):535-40. doi: 10.4088/JCP.15m09787.
- Derived from this study: PubMed 25782762Spinelli MG, Endicott J, Goetz RR. Disagreement between therapist raters and independent evaluators in a controlled clinical trial of interpersonal psychotherapy for depressed pregnant women. J Psychiatr Pract. 2015 Mar;21(2):114-23. doi: 10.1097/01.pra.0000462604.79606.4e.
- Derived from this study: PubMed 23971683Spinelli MG, Endicott J, Goetz RR. Increased breastfeeding rates in black women after a treatment intervention. Breastfeed Med. 2013 Dec;8(6):479-84. doi: 10.1089/bfm.2013.0051. Epub 2013 Aug 24.
- Derived from this study: PubMed 23656847Spinelli MG, Endicott J, Leon AC, Goetz RR, Kalish RB, Brustman LE, Carmona YR, Meyreles Q, Vega M, Schulick JL. A controlled clinical treatment trial of interpersonal psychotherapy for depressed pregnant women at 3 New York City sites. J Clin Psychiatry. 2013 Apr;74(4):393-9. doi: 10.4088/JCP.12m07909.
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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.
Margaret G. Spinelli, MD principal investigator
New York State Psychiatric Institute
Jean Endicott, PhD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Interpersonal psychotherapy for depression in pregnancy and Parenting education program (PEP) in people with 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 8 inclusion and 7 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 26 Mar 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Depression (time frame: Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 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 NCT00251043, which also lists 5 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 26 Mar 2012.