Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), October 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00380419
  Purpose

This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.


Condition Intervention
Depression
Anxiety Disorders
Behavioral: Interpersonal Psychotherapy (IPT)

MedlinePlus related topics: Anxiety Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Infant Outcomes and Depression Treatment in Pregnancy

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17) [ Time Frame: Measured during pregnancy and the first 7 months after delivery ] [ Designated as safety issue: Yes ]
  • Infant birth outcomes [ Time Frame: Measured during the first 7 months after delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biologic measures related to depression in both mothers and infants [ Time Frame: Measured through 14 months fter delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive 16 sessions of interpersonal psychotherapy
Behavioral: Interpersonal Psychotherapy (IPT)
IPT sessions will address adjustment to pregnancy, concerns about interpersonal relationships, and parenting concerns. Sessions will be weekly, but may be determined by clinical desires of patient and therapist.

Detailed Description:

Depression is a serious illness that affects a person's body, mood, and thoughts. Researchers believe that it is one of the most common complications during and after pregnancy. The following symptoms may be signs of depression during pregnancy: 2 or more weeks of depressed mood; decreased interest or pleasure in activities; change in appetite or sleep patterns; fatigue or decreased energy; difficulty concentrating; excessive feelings of guilt or worthlessness; thoughts of suicide; and extreme restlessness or irritability. Depression is difficult to diagnose during pregnancy because its symptoms are sometimes confused with those of pregnancy. If left untreated, depression during pregnancy may affect not only the mother, but also the baby. Specifically, the hormone changes brought on by depression may contribute to premature and low-birth-weight infants. Interpersonal psychotherapy (IPT) is a short-term talking therapy that has been proven to be effective in treating depression. This study will evaluate the impact of interpersonal psychotherapy on the course of depression during and after pregnancy, as well as its effect on infant birth outcomes.

This study is associated with a larger parent study. Participants in this open-label study may be recruited directly for this study or through the parent study. All participants will receive 16 sessions of IPT. Sessions will last approximately 50 minutes and will focus on achieving depression symptom remission by improving interpersonal functioning. The majority of IPT sessions will be held prior to delivery; up to four sessions may be held postpartum. No medication will be provided in this study, but women who are currently taking selective serotonin uptake inhibitors (SSRIs) at the time of study entry may continue taking their medication. Participants whose symptoms do not improve with IPT will be referred to their non-study physician for further evaluation, and may begin taking SSRI medication upon physician recommendation. The effects of both IPT and medication therapy will be considered when assessing outcomes. Study visits will occur at 28, 32, and 36 weeks gestation, as well as Weeks 1, 2, and 6, and Month 6 postpartum. Measurements will include cortisol levels, which will be obtained using a saliva sample, as well as depression symptom severity, which will be assessed at each IPT session. Blood samples will be taken as part of the parent study.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No more than 28 weeks pregnant at the time of study entry
  • History of depression or anxiety
  • Current symptoms of distress
  • Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS)
  • English-speaking

Exclusion Criteria:

  • Plans to move away from the area prior to giving birth
  • Current use of steroids for medical conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380419

Contacts
Contact: Katherine H. Bullard, MSW, MPH 734-763-4904 krharris@umich.edu
Contact: Susan E. Hamilton, MS 734-615-6493 sueileen@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Sheila M Marcus, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Sheila M. Marcus, MD Universitiy of Michigan
  More Information

Click here for more information at the University of Michigan Clinical Research Website  This link exits the ClinicalTrials.gov site
Click here for the University of Michigan Depression Center's website on Interpersonal Therapy  This link exits the ClinicalTrials.gov site
Click here for the University of Michigan Depression Center's website on A Woman's Guide to Understanding Depression  This link exits the ClinicalTrials.gov site

Responsible Party: University of Michigan ( Sheila M. Marcus, MD )
Study ID Numbers: R21 MH72673, DSIR 83-ATAS
Study First Received: September 22, 2006
Last Updated: October 21, 2008
ClinicalTrials.gov Identifier: NCT00380419  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Pregnancy
Postpartum Depression

Study placed in the following topic categories:
Depression
Anxiety Disorders
Depression, Postpartum
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 30, 2009