Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy

Depression Clinical Trial

Official title:

Infant Outcomes and Depression Treatment in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380419
• Other study ID #: HUM00007344
• Secondary ID: R21MH072673DSIR
• Status: Completed
• Phase: N/A
• First received: September 22, 2006
• Last updated: May 29, 2013
• Start date: October 2006
• Est. completion date: August 2009

Study information

• Verified date: May 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)		Measured during pregnancy and the first 7 months after delivery	Yes
Primary	Infant birth outcomes		Measured during the first 7 months after delivery	No
Secondary	Biologic measures related to depression in both mothers and infants		Measured through 14 months fter delivery	No

External Links

•   Click here for the University of Michigan Depression Center's website on A Woman's Guide to Understanding Depression
•   Click here for the University of Michigan Depression Center's website on Interpersonal Therapy