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Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sheila M Marcus, University of Michigan
ClinicalTrials.gov Identifier:
NCT00380419
First received: September 22, 2006
Last updated: May 29, 2013
Last verified: May 2013
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infant Outcomes and Depression Treatment in Pregnancy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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 ]

Enrollment: 120
Study Start Date: October 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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: NCT00380419

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

Additional Information:
No publications provided

Responsible Party: Sheila M Marcus, Section Director Child & Adolescent Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT00380419     History of Changes
Other Study ID Numbers: HUM00007344, R21MH072673, DSIR 83-ATAS
Study First Received: September 22, 2006
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Pregnancy
Postpartum Depression

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

ClinicalTrials.gov processed this record on November 25, 2014