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- Klinische proef NCT00380419
Effects of Interpersonal Psychotherapy on Depression During and After Pregnancy
Infant Outcomes and Depression Treatment in Pregnancy
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Participants will receive 16 sessions of interpersonal psychotherapy
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Mothers' depression symptom severity, as determined by the 17-item Hamilton Rating Scale for Depression (HAM-D 17)
Tijdsspanne: 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
Tijdsspanne: Measured during the first 7 months after delivery
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Measured during the first 7 months after delivery
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Biologic measures related to depression in both mothers and infants
Tijdsspanne: Measured through 14 months fter delivery
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Measured through 14 months fter delivery
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sheila M. Marcus, MD, Universitiy of Michigan
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HUM00007344
- DSIR 83-ATAS (NIMH Program Class Code)
- R21MH072673 (Subsidie/contract van de Amerikaanse NIH)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Interpersonal Psychotherapy (IPT)
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University College, LondonNog niet aan het wervenOntsteking | Parodontale aandoeningenVerenigd Koninkrijk
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Children's Hospital of PhiladelphiaNational Institute of Mental Health (NIMH); Rutgers UniversityVoltooidDepressieVerenigde Staten
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University of PittsburghVoltooidDepressie | Angst stoornissen | PaniekstoornisVerenigde Staten
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First Affiliated Hospital of Zhejiang UniversityWerving
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University of GeorgiaColumbia University; Ohio UniversityVoltooidDepressie | Hiv/aids
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Johns Hopkins UniversityNational Institute of Mental Health (NIMH)VoltooidErnstige stemmingsdisregulatieVerenigde Staten
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Linkoeping UniversityUniversity College, LondonVoltooid
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New York State Psychiatric InstituteVoltooidUnipolaire depressie | DysthymieVerenigde Staten
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University of IowaNational Institute of Mental Health (NIMH)VoltooidDepressie | Depressie, postpartumVerenigde Staten
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DBL -Institute for Health Research and DevelopmentVoltooidMalaria | BloedarmoedeGhana