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Completed

NCT Number: NCT00380419

Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

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.

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Psychotherapy (IPT)

Behavioral

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 outcomes

  1. 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

  2. Infant birth outcomes

    Time frame: Measured during the first 7 months after delivery

Secondary outcomes

  1. Biologic measures related to depression in both mothers and infants

    Time frame: Measured through 14 months fter delivery

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Infant Outcomes and Depression Treatment in Pregnancy

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2006
Registry last updated
May 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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