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Multidisciplinary Model of Nurse Midwife

5. august 2015 opdateret af: Barbara Posmontier, Drexel University

Multidisciplinary Model of Nurse Midwife Psychotherapy for Postpartum Depression

HYPOTHESES:

The hypotheses are that:

  1. nurse midwives will be able to safely deliver interpersonal psychotherapy by telephone to women with postpartum depression
  2. women receiving interpersonal psychotherapy will have less symptoms of postpartum depression, better functioning, better bonding with their babies, and better relationships with their partners
  3. women with postpartum depression will be more satisfied with their care than women in the group that was referred to a mental health center.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The specific aims of this pilot non-randomized clinical trial are to evaluate among women with PPD recruited between 6 and 24 weeks postpartum:

  1. The (a) feasibility, (b) acceptability and (c) safety of a psychological intervention (Interpersonal Psychotherapy [IPT]) provided by nurse midwives in collaboration with a mental health team (psychiatrist team leader and a licensed social worker) for treatment of PPD in a pilot two-armed non-randomized clinical trial.
  2. The preliminary evidence of efficacy of IPT in decreasing depressive symptoms when administered via telephone by nurse-midwives/ women's health nurse practitioner

  3. The proposed study will also evaluate preliminary evidence for the efficacy of IPT administered by nurse midwives in

    1. Improving the general level of maternal functioning
    2. Specific improvement in marital adjustment
    3. Increase in maternal infant bonding

This pilot study is the first step in developing an intervention to decrease depressive symptoms, improve functioning, improve interpersonal relationships between mother and spouse and infant, improve access to care, and improve treatment engagement among postpartum women diagnosed with PPD. The intervention will be cost-effective, brief and acceptable to both patients and nurse midwives for incorporation into current midwifery practice. If the IPT program is found to be feasible, acceptable and safe with preliminary evidence of efficacy, a postpartum IPT manual for advanced practice nurses will be finalized in order to test whether other advanced practice nurses such as pediatric nurse practitioners and family nurse practitioners can also safely and effectively administer IPT in a full-scale randomized clinical trial

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Phila, Pennsylvania, Forenede Stater, 19102
        • Drexel University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 6 to 24 weeks postpartum
  • 16 years and older
  • English-speaking
  • Have access to a telephone
  • Consents to enter the trial
  • Postpartum onset of postpartum depression
  • Current use of antidepressant medication as long as dose does not have to be adjusted by subject's healthcare provider during clinical trial

Exclusion Criteria:

  • Infant complications requiring medical care beyond 6 weeks postpartum
  • Infant birth defects
  • Infant being placed for adoption by 6 weeks postpartum
  • Maternal mental retardation
  • Current use of antidepressant medication that requires dosage adjustment by subject's healthcare provider during clinical trial
  • Diagnosis of depression prior to postpartum period
  • Active substance or alcohol abuse or dependence
  • Active suicidality, homicidality, or current psychosis as assessed by the MINI
  • Disabling pain that interferes with the ability to carry out activities of daily living
  • Concurrent serious medical co-morbidities (e.g. active lupus, multiple sclerosis, severe cardiac disease severe hypertension, cancer, etc).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CNM Interpersonal Psychotherapy
CNM Interpersonal psychotherapy
Adfærdsmæssigt: CNM Interpersonal Psychotherapy
Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
Aktiv komparator: Treatment as Usual
Treatment as Usual is psychotherapy with a mental health provider
Adfærdsmæssigt: Treatment as Usual
Treatment as Usual is psychotherapy provided by a mental health provider

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Hamilton Rating Scale for depression
Tidsramme: 12 weeks
Measure of depression severity
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Global Assessment of functioning
Tidsramme: 12 weeks
Measure of functional status
12 weeks
Dyadic Adjustment Scale
Tidsramme: 12 weeks
Measure of dyadic adjustment of marital couple
12 weeks
Social Support Questionnaire
Tidsramme: 12 weeks
Measure of improvement in social support
12 weeks
Client Satisfaction Questionnaire
Tidsramme: 12 weeks
Measure of client satisfaction with midwife counseling
12 weeks
Edinburgh Postnatal Depression Scale
Tidsramme: 12 weeks
Measure of severity of postpartum depression
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Drexel University

Efterforskere

  • Ledende efterforsker: Barbara E Posmontier, PHD, Drexel University
  • Ledende efterforsker: Richard Neugebauer, PhD, Columbia University
  • Ledende efterforsker: Rita Shaughnessy, PhD, MD, Drexel University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

24. maj 2010

Først indsendt, der opfyldte QC-kriterier

30. august 2013

Først opslået (Skøn)

5. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2015

Sidst verificeret

1. august 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18981

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fødselsdepression

Kliniske forsøg med CNM Interpersonal Psychotherapy

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Placeringer

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