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Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group interpersonal therapy (IPT)
Treatment as usual (TAU)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prenatal Depression, Postpartum Depression, Fetal Development, Interpersonal Therapy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Score of at least 10 on the Edinburgh Postnatal Depression Scale (EPDS)

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Group Interpersonal Therapy (IPT)

Treatment as Usual (ETAU)

No Treatment

Arm Description

Participants will receive group interpersonal therapy.

Participants will receive psychiatric treatment as usual.

Participants are healthy and will receive no treatment.

Outcomes

Primary Outcome Measures

Improved prenatal mood
Hamilton Scales for Depression Score
Postpartum depression
Hamilton Scales for Depression Score

Secondary Outcome Measures

Full Information

First Posted
March 7, 2008
Last Updated
June 29, 2021
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00633178
Brief Title
Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression
Official Title
Therapy for Prenatal Depression: Maternal & Fetal Effects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Prenatal Depression, Postpartum Depression, Fetal Development, Interpersonal Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Interpersonal Therapy (IPT)
Arm Type
Experimental
Arm Description
Participants will receive group interpersonal therapy.
Arm Title
Treatment as Usual (ETAU)
Arm Type
Active Comparator
Arm Description
Participants will receive psychiatric treatment as usual.
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
Participants are healthy and will receive no treatment.
Intervention Type
Behavioral
Intervention Name(s)
Group interpersonal therapy (IPT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improved prenatal mood
Description
Hamilton Scales for Depression Score
Time Frame
Measured during the prenatal period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)
Title
Postpartum depression
Description
Hamilton Scales for Depression Score
Time Frame
Measured during the postpartum period (pregnant participants enroll at 23/24 weeks gestation and are assessed through 40 weeks of gestations)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Score of at least 10 on the Edinburgh Postnatal Depression Scale (EPDS) Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Monk, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression

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