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Trial record 14 of 902 for:    depression AND (woman OR women OR female)

Effectiveness of Group Interpersonal Psychotherapy in Treating Women With Prenatal Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00633178
First received: March 7, 2008
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Depression
Behavioral: Group interpersonal therapy (IPT)
Behavioral: Treatment as usual (TAU)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Therapy for Prenatal Depression: Maternal & Fetal Effects

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Improved prenatal mood [ Time Frame: Measured during the prenatal period ] [ Designated as safety issue: No ]
  • Postpartum depression [ Time Frame: Measured during the postpartum period ] [ Designated as safety issue: No ]
  • Fetal and newborn outcomes as compared with those of healthy control women's offspring [ Time Frame: Measured during the fetal and newborn period ] [ Designated as safety issue: No ]

Enrollment: 116
Study Start Date: January 2005
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive group interpersonal therapy.
Behavioral: 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.
Active Comparator: 2
Participants will receive psychiatric treatment as usual.
Behavioral: 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.
No Intervention: 3
Participants are healthy and will receive no treatment.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633178

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Catherine Monk, PhD Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00633178     History of Changes
Other Study ID Numbers: R34 MH072838, #4914, R34MH072838, DSIR 83-ATP
Study First Received: March 7, 2008
Last Updated: December 27, 2011
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Prenatal Depression
Postpartum Depression
Fetal Development
Interpersonal Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014