Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Recruitment status was Recruiting
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| First Received Date ICMJE | September 22, 2006 | ||||||||
| Last Updated Date | March 23, 2009 | ||||||||
| Start Date ICMJE | October 2006 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00380419 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Biologic measures related to depression in both mothers and infants [ Time Frame: Measured through 14 months fter delivery ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Biologic measures related to depression in both mothers and infants | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy | ||||||||
| Official Title ICMJE | Infant Outcomes and Depression Treatment in Pregnancy | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: 1
Participants will receive 16 sessions of interpersonal psychotherapy
Intervention: Behavioral: Interpersonal Psychotherapy (IPT) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | August 2009 | ||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 21 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00380419 | ||||||||
| Other Study ID Numbers ICMJE | R21 MH072673, DSIR 83-ATAS | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Sheila M. Marcus, MD, University of Michigan | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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