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

September 22, 2006
May 29, 2013
October 2006
August 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17) (measured at each IPT session)
  • Infant birth outcomes
Complete list of historical versions of study NCT00380419 on ClinicalTrials.gov Archive Site
Biologic measures related to depression in both mothers and infants [ Time Frame: Measured through 14 months fter delivery ] [ Designated as safety issue: No ]
Biologic measures related to depression in both mothers and infants
Not Provided
Not Provided
 
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Infant Outcomes and Depression Treatment in 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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Depression
  • Anxiety Disorders
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.
Experimental: 1
Participants will receive 16 sessions of interpersonal psychotherapy
Intervention: Behavioral: Interpersonal Psychotherapy (IPT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Female
21 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00380419
HUM00007344, R21MH072673, DSIR 83-ATAS
Yes
Sheila M Marcus, University of Michigan
University of Michigan
National Institute of Mental Health (NIMH)
Principal Investigator: Sheila M. Marcus, MD Universitiy of Michigan
University of Michigan
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP