DepressionNCT00633178
Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression
A study testing Group interpersonal therapy (IPT) and Treatment as usual (TAU) 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 group interpersonal psychotherapy for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies. 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
- What is being tested?
- Group interpersonal therapy (IPT) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2009
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Score of at least 10 on the Edinburgh Postnatal Depression Scale (EPDS)
Who cannot join
- Multi-fetal pregnancy
- Taking medications that affect the cardiovascular system (e.g., doxazosin)
- History of suicide attempt or current suicidal ideation
- Psychotic features
- Life-time history of bipolar disorder
- Current eating disorder
Show all 13Show fewer
- Currently diagnosed with any of the following: obsessive compulsive disorder, major depression with melancholic features, severe major depression, panic disorder, organic brain syndrome, mental retardation, antisocial personality disorder, borderline personality disorder, or presence of three or more schizotypal features
- Smokes cigarettes
- Substance dependence or abuse
- Complicated pregnancy or delivery
- Premature delivery
- Neonate medical/developmental problems
- Taking a psychotropic medication at the time of the initial phone contact with study investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Therapy for Prenatal Depression: Maternal & Fetal Effects
This study will evaluate the effectiveness of group interpersonal psychotherapy for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies.
Read the detailed description
The pregnancy and postpartum periods are times of remarkable emotional and physical change for a woman, making pregnant women more vulnerable to mood swings and depressive symptoms. It is estimated that approximately 10% to 15% of pregnant women experience depression, which can cause severe psychological distress for the woman as well as disturbances in infant development. Infants of depressed mothers are at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Moreover, new data indicate that prenatal depression also may adversely affect brain development of the child even before birth. Despite the high prevalence rates of prenatal depression and its negative consequences, few studies have tested the effectiveness of interpersonal psychotherapy (IPT), a treatment for depression that focuses on interpersonal issues and relationships, during pregnancy. The administration of group prenatal IPT for depression may be effective in enhancing women's prenatal and postpartum moods and improving fetal and newborn functioning. This study will compare the effectiveness of group IPT with that of treatment as usual (TAU) for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies. The study will also compare the fetal and newborn development of babies of healthy mothers with that of babies of depressed mothers.
This study will involve both healthy participants and participants with depression. All participants will start with an initial assessment visit between the 22nd and 23rd weeks of pregnancy. For participants who have shown signs of depression based on an initial phone interview, the initial visit will last about 2 hours and will include questions about medical and psychiatric history, depressive symptoms, and lifestyle habits and an examination of uterine blood flow using a Doppler ultrasound machine. Participants who do not show signs of depression will not undergo these assessments on the initial visit.
Participants found to be depressed on the first visit will then be assigned randomly to receive group IPT or TAU. Participants assigned to group IPT will attend 12 weekly psychiatrist-led sessions that will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women. Participants assigned to TAU will be referred to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving antidepressant medication may last longer than 12 weeks. During the treatment period, all participants will fill out weekly forms about their moods and will have monthly interviews with a psychiatrist. Upon completion of treatment, participants will have a 30-minute final evaluation meeting.
All participants, including healthy participants, will be asked to attend two sessions focused on their babies' development, one occurring between the 36th and 38th weeks of pregnancy and one shortly after giving birth. During the first developmental session, participants will complete a questionnaire about mood; undergo heart rate, breathing, and blood pressure monitoring; undergo an ultrasound; and perform a word matching task. The second developmental session will occur between 20 and 30 hours after birth of the baby and will include a newborn testing session that will consist of physiological and neurobehavioral assessments. Healthy participants' study participation will be over upon completion of the second developmental session. Depressed participants will be contacted by phone once every 2 weeks for 6 months after giving birth.
- Conditions
- Depression
- Being tested
- Group interpersonal therapy (IPT), Treatment as usual (TAU)
- Keywords
- Prenatal Depression, Postpartum Depression, Fetal Development, Interpersonal Therapy
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group interpersonal therapy (IPT)Behavioural
Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women.
Treatment as usual (TAU)Behavioural
TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group Interpersonal Therapy (IPT) | Experimental | Participants will receive group interpersonal therapy. Receives: Behavioral: Group interpersonal therapy (IPT) |
| Treatment as Usual (ETAU) | Active comparator | Participants will receive psychiatric treatment as usual. Receives: Behavioral: Treatment as usual (TAU) |
| No Treatment | No intervention | Participants are healthy and will receive no treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved prenatal mood
Hamilton Scales for Depression Score
Measured: Measured during the prenatal period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)
Postpartum depression
Hamilton Scales for Depression Score
Measured: Measured during the postpartum period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startJan 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 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
- Catherine Monk, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633178
- Sponsor's protocol ID
- R34MH072838, #4914
- Other IDs
- R34MH072838
- Status last verified
- Dec 2011
- First submitted
- 7 Mar 2008
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy for Prenatal Depression: Maternal & Fetal Effects
- ClinicalTrials.gov ID
- NCT00633178
- Acronym / sponsor ID
- R34MH072838, #4914
- Conditions
- Depression
- Keywords
- Prenatal Depression, Postpartum Depression, Fetal Development, Interpersonal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Mar 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 group interpersonal psychotherapy for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies.
Detailed description
The pregnancy and postpartum periods are times of remarkable emotional and physical change for a woman, making pregnant women more vulnerable to mood swings and depressive symptoms. It is estimated that approximately 10% to 15% of pregnant women experience depression, which can cause severe psychological distress for the woman as well as disturbances in infant development. Infants of depressed mothers are at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Moreover, new data indicate that prenatal depression also may adversely affect brain development of the child even before birth. Despite the high prevalence rates of prenatal depression and its negative consequences, few studies have tested the effectiveness of interpersonal psychotherapy (IPT), a treatment for depression that focuses on interpersonal issues and relationships, during pregnancy. The administration of group prenatal IPT for depression may be effective in enhancing women's prenatal and postpartum moods and improving fetal and newborn functioning. This study will compare the effectiveness of group IPT with that of treatment as usual (TAU) for preventing postpartum depression in pregnant women with depression and for improving healthy outcomes in their babies. The study will also compare the fetal and newborn development of babies of healthy mothers with that of babies of depressed mothers.
This study will involve both healthy participants and participants with depression. All participants will start with an initial assessment visit between the 22nd and 23rd weeks of pregnancy. For participants who have shown signs of depression based on an initial phone interview, the initial visit will last about 2 hours and will include questions about medical and psychiatric history, depressive symptoms, and lifestyle habits and an examination of uterine blood flow using a Doppler ultrasound machine. Participants who do not show signs of depression will not undergo these assessments on the initial visit.
Participants found to be depressed on the first visit will then be assigned randomly to receive group IPT or TAU. Participants assigned to group IPT will attend 12 weekly psychiatrist-led sessions that will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women. Participants assigned to TAU will be referred to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving antidepressant medication may last longer than 12 weeks. During the treatment period, all participants will fill out weekly forms about their moods and will have monthly interviews with a psychiatrist. Upon completion of treatment, participants will have a 30-minute final evaluation meeting.
All participants, including healthy participants, will be asked to attend two sessions focused on their babies' development, one occurring between the 36th and 38th weeks of pregnancy and one shortly after giving birth. During the first developmental session, participants will complete a questionnaire about mood; undergo heart rate, breathing, and blood pressure monitoring; undergo an ultrasound; and perform a word matching task. The second developmental session will occur between 20 and 30 hours after birth of the baby and will include a newborn testing session that will consist of physiological and neurobehavioral assessments. Healthy participants' study participation will be over upon completion of the second developmental session. Depressed participants will be contacted by phone once every 2 weeks for 6 months after giving birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Interpersonal Therapy (IPT) | Experimental | Behavioral: Group interpersonal therapy (IPT)Participants will receive group interpersonal therapy. |
| Treatment as Usual (ETAU) | Active comparator | Behavioral: Treatment as usual (TAU)Participants will receive psychiatric treatment as usual. |
| No Treatment | No intervention | –Participants are healthy and will receive no treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Score of at least 10 on the Edinburgh Postnatal Depression Scale (EPDS)
Key exclusion criteria (13 listed)
- Multi-fetal pregnancy
- Taking medications that affect the cardiovascular system (e.g., doxazosin)
- History of suicide attempt or current suicidal ideation
- Psychotic features
- Life-time history of bipolar disorder
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 |
|---|---|---|
| Group interpersonal therapy (IPT)Group IPT will include weekly treatment sessions with a psychiatrist for 12 weeks. The sessions will focus on overcoming relationship problems associated with depression. The first two and last sessions will be alone with the psychiatrist and the remaining sessions will be with a group of five to eight other pregnant women. | Behavioural | Group Interpersonal Therapy (IPT) |
| Treatment as usual (TAU)TAU will include referrals to outpatient treatment, which may include cognitive behavioral psychotherapy, insight-oriented psychotherapy, and/or antidepressant medication. TAU participants receiving psychotherapy will attend 12 weekly treatment sessions comparable to the IPT group sessions; treatment for TAU participants receiving medication for their depression may last longer than 12 weeks. | Behavioural | Treatment as Usual (ETAU) |
Primary outcome
Improved prenatal mood
Time frame: Measured during the prenatal period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)
Hamilton Scales for Depression Score
Postpartum depression
Time frame: Measured during the postpartum period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)
Hamilton Scales for Depression Score
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 1 Jul 2021.
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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 Monk, PhD 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 Group interpersonal therapy (IPT) and Treatment as usual (TAU) 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 1 inclusion and 13 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 1 Jul 2021. 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?
Improved prenatal mood (time frame: Measured during the prenatal period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)). 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?
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 1 Jul 2021.