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Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

Primary Purpose

Depression, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy (IPT)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Pregnancy, Postpartum Depression

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Participants will receive 16 sessions of interpersonal psychotherapy

Outcomes

Primary Outcome Measures

Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)
Infant birth outcomes

Secondary Outcome Measures

Biologic measures related to depression in both mothers and infants

Full Information

First Posted
September 22, 2006
Last Updated
May 29, 2013
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00380419
Brief Title
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Official Title
Infant Outcomes and Depression Treatment in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety Disorders
Keywords
Pregnancy, Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive 16 sessions of interpersonal psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy (IPT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Infant birth outcomes
Time Frame
Measured during the first 7 months after delivery
Secondary Outcome Measure Information:
Title
Biologic measures related to depression in both mothers and infants
Time Frame
Measured through 14 months fter delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M. Marcus, MD
Organizational Affiliation
Universitiy of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.umms.med.umich.edu/engage/detail_pub_study.do?id=1669&TYPE=F
Description
Click here for more information at the University of Michigan Clinical Research Website

Learn more about this trial

Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

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