- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00380419
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Infant Outcomes and Depression Treatment in Pregnancy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
Participants will receive 16 sessions of interpersonal psychotherapy
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)
Tidsramme: Measured during pregnancy and the first 7 months after delivery
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Measured during pregnancy and the first 7 months after delivery
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Infant birth outcomes
Tidsramme: Measured during the first 7 months after delivery
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Measured during the first 7 months after delivery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Biologic measures related to depression in both mothers and infants
Tidsramme: Measured through 14 months fter delivery
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Measured through 14 months fter delivery
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sheila M. Marcus, MD, Universitiy of Michigan
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HUM00007344
- DSIR 83-ATAS (NIMH Program Class Code)
- R21MH072673 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Depression
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ProgenaBiomeRekrutteringDepression | Depression, postpartum | Depression, angst | Depression Moderat | Depression Alvorlig | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskForenede Stater
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Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekrutteringDepression | Depression Moderat | Depression Alvorlig | Depression MildForenede Stater
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Washington University School of MedicineAfsluttetBehandlingsresistent depression | Senlivsdepression | Geriatrisk depression | Refraktær depression | Terapi-resistent depressionForenede Stater, Canada
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University of California, San FranciscoRekrutteringDepression Moderat | Depression Mild | Depression, teenagerForenede Stater
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University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RekrutteringDepression Moderat | Depression Alvorlig | Depression MildBelgien
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Baylor College of MedicineUniversity of TexasRekrutteringDepression | Depression Moderat | Depression Alvorlig | Selvmord og selvskade | Depression i ungdomsårene | Depression MildForenede Stater
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Charite University, Berlin, GermanyAfsluttetBehandlingsresistent depression | Depression, Unipolar | Depression KroniskTyskland
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Northern Illinois UniversityUniversity Autonoma de Santo DomingoAfsluttetDepression Moderat | Depression MildForenede Stater, Dominikanske republik
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University of California, San FranciscoIkke rekrutterer endnuDepression Moderat | Depression MildForenede Stater
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University of BernAfsluttetDepression Moderat | Depression MildSchweiz
Kliniske forsøg med Interpersonal Psychotherapy (IPT)
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University College, LondonIkke rekrutterer endnuBetændelse | Periodontale sygdommeDet Forenede Kongerige
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Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); Rutgers UniversityAfsluttetDepressionForenede Stater
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University of PittsburghAfsluttetDepression | Angstlidelser | PaniklidelseForenede Stater
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Johns Hopkins UniversityNational Institute of Mental Health (NIMH)Afsluttet
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First Affiliated Hospital of Zhejiang UniversityRekruttering
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University of OregonAfsluttet
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University of GeorgiaColumbia University; Ohio UniversityAfsluttetDepression | HIV/AIDS
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Linkoeping UniversityUniversity College, LondonAfsluttet
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New York State Psychiatric InstituteAfsluttetUnipolar depression | DystymiForenede Stater
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University of IowaNational Institute of Mental Health (NIMH)Afsluttet